The International Council on Infertility Information Dissemination, Inc

12th Edition of the EMD Serono Specialty Digest™ Now Available

Scott Filosi, Senior Vice President, Market Access & Customer Solutions, EMD Serono

Scott Filosi, Senior Vice President, Market Access & Customer Solutions, EMD Serono

Value of specialty medicines, appropriate clinical use identified as critical managed care challenges

ROCKLAND, Mass., May 9, 2016 /PRNewswire/ -- EMD Serono, the North America biopharmaceutical business of Merck KGaA, Darmstadt, Germany, announced the release of the 12th edition of the EMD Serono Specialty Digest™.  The Digest, which was featured last week at the Asembia Specialty Pharmacy Summit in Las Vegas, NV,  is an industry resource that provides market data on health plans' management of specialty pharmaceuticals in 2015 and identifies common trends occurring across plans. The Digest is available to those who request a copy at http://www.specialtydigest.emdserono.com.

"EMD Serono has a longstanding commitment to customers and patients to further the understanding of trends in the management of specialty pharmaceuticals and ultimately, improve patient outcomes," said Scott Filosi, Senior Vice President, Market Access & Customer Solutions, EMD Serono. "It is our hope that this year's Digest findings will help spur conversations around ways to ensure continued patient access to optimal care." 

The 12th edition of the EMD Serono Specialty Digest includes data from 58 commercial health plans across the country, representing more than 140 million covered lives. New to the Digest this year is an oncology-specific supplement that includes a deeper analysis into the therapeutic category, which continues to be a major focus for health plans.  The new oncology-specific supplement is scheduled to be available in June.

"The findings in the area of oncology shed light on new trends such as the adoption of clinical pathways as well as concerns around restricting product use and the cost of infusion site visits for payers," said Kevin Host, President, Artemetrx, who oversaw the development of this year's Digest. "Understanding these managed care challenges as they relate to oncology is an important step in better meeting the needs of patients."

Further findings from this year's Digest show that while alignment of pharmacy and medical benefits has improved, it still remains a major issue for some plans. Additionally, plans are more likely to select preferred products and to exclude non-preferred agents as a therapy class matures post-launch. 

The EMD Serono Specialty Digest was first developed in 2004 to provide a comprehensive reference for managed care decision makers regarding the management of specialty products. Over the past twelve years, health plans, Pharmacy Benefit Managers (PBMs), employers, specialty pharmacies, and pharmaceutical companies have relied on the Digest to identify current and future trends in the management of specialty pharmaceuticals.

About EMD Serono, Inc. 
EMD Serono is the North America biopharma business of Merck KGaA, Darmstadt, Germany - a leading science and technology company - focused exclusively on specialty care. For more than 40 years, the business has integrated cutting-edge science, innovative products and industry-leading patient support and access programs. EMD Serono has deep expertise in neurology, fertility and endocrinology, as well as a robust pipeline of potential therapies in oncology, immuno-oncology and immunology as R&D focus areas. Today, the business has more than 1,100 employees around the country with commercial, clinical and research operations based in the company's home state of Massachusetts.

www.emdserono.com

About Merck KGaA, Darmstadt, Germany
All Merck KGaA, Darmstadt, Germany, press releases are distributed by e-mail at the same time they become available on the EMD Group Website. In case you are a resident of the USA or Canada please go towww.emdgroup.com/subscribe to register again for your online subscription of this service as our newly introduced geo-targeting requires new links in the email. You may later change your selection or discontinue this service.

Merck KGaA, Darmstadt, Germany, is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2015, Merck KGaA, Darmstadt, Germany, generated sales of € 12.8 billion in 66 countries.

Founded in 1668, Merck KGaA, Darmstadt, Germany, is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck KGaA, Darmstadt, Germany, holds the global rights to the Merck KGaA, Darmstadt, Germany, name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.

Your Contact
Melissa Manganello 1-781-681-2393

Photo - http://photos.prnewswire.com/prnh/20160509/365030

SOURCE EMD Serono

RELATED LINKS
http://www.emdserono.com

Traditional Chinese Medicine in the Treatment of Infertility

Photo of Chines Stones with words representing the therapy (calm, smooth, peace)

Photo of Chines Stones with words representing the therapy (calm, smooth, peace)Traditional Chinese Medicine in the Treatment of Infertility

by Mike Berkley, L.Ac., FABORM 
The Berkley Center 
    (Note: Register and Join us on April 8 at 7:30 ET. Mike will answer your questions about how to use acupuncture and herbs to enhance fertility.)

Although the goals of Complementary medicine and conventional Western medicine are the same, their ideas about what causes a disease, the nature of the disease itself, and the process used to regain health are very different. The physician learns that disease must be cured by prescribing medicine or by surgery. There is nothing inherently wrong with this approach. It often works. But why does Complementary medicine succeed where conventional Western medicine sometimes fails? What is it about acupuncture and herbal medicine that can result in relief of symptoms or even a cure that is often lacking in conventional Western medicine? 

Though the ultimate result of Complementary medicine care is to cure the patient, the doctor of Complementary medicine attempts to do this by treating the whole person, taking into account the various attributes of an individual that, when combined, account for an individual’s health status.  A person, according to the tenets of Complementary medicine, is more than their condition. To treat just the condition may yield results, but, however impressive, these results are usually temporary. 

People are not, according to Complementary medicine, represented solely by their illness, but by the accumulation of every human interaction engaged in from the moment of their birth and by the culture they are exposed to. The emotional experiences, eating habits, work habits, work and living environment, personal habits, and social network all contribute to their disease, and are factors that, when changed appropriately, may lead to regained health.  

The power and effectiveness of Chinese medicine is evidenced by its long history of continued success. More than a quarter of the world’s population currently uses Complementary medicine as part of their health-care regimen. Chinese medicine is the only form of classical medicine that is regularly and continuously used outside of its country of origin.

The experienced doctor must use his or her own interpretive skills and consider not only what the patient reports to them about their condition, but also what they reveal without meaning too and what they don’t express. This leads to a better understanding of who the patient is and what the deeper, underlying cause of their condition may be.

The practitioner of Chinese medicine is trained to observe one’s tone of voice, complexion, eyes (in Complementary medicine, the shen or sprit of an individual is said to be revealed through the eyes), facial expression, overall demeanor, and how one walks, sits, and stands, and to use these observations to arrive at a diagnosis. Before the patient says one word, the doctor already has some idea of who this person is, clinically, simply by observing them.

A great doctor is one who can process a mix of medical knowledge with a personal sensitivity based on experience.  The practitioner of Complementary medicine specializes not just in inserting needles or prescribing herbal remedies, but in being able to see ‘hidden’ or subtle conditions that may not been seen or understood by practitioners of other types of medicine. This ability to see these hidden elements is difficult to master, and is done without the benefit of modern technology.

The only diagnostic tools used by practitioners of Chinese medicine are the “Four Examinations”: Observing, Listening/Smelling, Questioning, and Palpating. This method of diagnosis dates back over 3,000 years, and although it may seem quite simple, it is far from simplistic. Each of the Four Examinations can take years to master, and the astute practitioner uses them to arrive at a differential diagnosis.  With the advent of technology—as amazing, necessary, and beneficial as it is—there seems to be a direct correlation between advances in technology and a decline in doctor sensitivity to the patient, and thus, misdiagnosis.  The ability to listen and observe clearly, yields gems that are clues to the cause of disease.  This is the stuff of Complementary medicine.

Proper treatment in Complementary medicine is more than the elimination of the disease.  In addition to attacking a factor that is contributing to the disease process, it is the responsibility of the practitioner of Complementary medicine to support the individual in his or her goal of achieving overall total health, which includes the physical, psychological, emotional, and spiritual aspects of the patient.  This multidimensional approach is crucial to the process of healing. Without it, practitioner are merely “chasing” the sickness and forgetting that the patient is much more than their disease. They are a whole person—the sum of a lifetime of experiences.

Pathologies are guests (and we hope temporary ones!) in a home that serves as a gracious host—our physical, emotional, and spiritual selves.  Complementary medicine first is concerned with strengthening the immune function, which includes balancing the physical, emotional, and spiritual attributes of the patient, so as to be able to assist the patient in his or her endeavor to do battle and destroy the “enemy at the gates.” When people can’t sleep because they are anxious and depressed, they become chronically exhausted and chronically sick as a result of a compromised immune system.

The key to cure is to not view curing the disease itself as the be-all and end-all in treatment, but instead to treat the root of the disease—the anxiety and depression that causes the insomnia, which facilitates exhaustion, which lowers the immune function, which leads to chronic illnesses. So rather than prescribing antibiotics repeatedly, a practitioner of Complementary medicine might address the patient’s anxiety/depression syndrome or refer them to a psychotherapist for appropriate intervention while simultaneously providing Complementary forms of treatment.

Infertility and Complementary Medicine:  Mechanisms of Action

Historically, infertility—particularly “functional” infertility—was attributed to psychological problems of one or both partners. Preliminary works in the 1940s and 1950s considered “psychogenic infertility” as the major cause of failure to conceive in as many as 50% of cases. As recently as the late 1960s, it was commonly believed that reproductive failure was the result of psychological and emotional factors. Psychogenic infertility was supposed to occur because of unconscious anxiety about sexual feelings, ambivalence toward motherhood, unresolved Oedipal conflict, or conflicts of gender identity.

Fortunately, advances in reproductive endocrinology and medical technology, as well as in psychological research, have de-emphasized the significance of psychopathology as the basis of infertility. Stress does, however, play a part.

A study done at Harvard showed that stress reduces the hypothalamic-anterior-pituitary-ovarian axis function, and should thus be considered in the infertility workup. Acupuncture releases endorphins that mitigate one’s response to stressful stimuli, thus enhancing the possibility of conception. Biologically, since the hypothalamus regulates both stress responses as well as the sex hormones, it’s easy to see how stress may contribute to infertility in some women.

Excessive physical stress may even lead to complete suppression of the menstrual cycle, and this is often seen in female marathon runners, who develop “runner’s amenorrhea.” In less severe cases, it could cause anovulation or irregular menstrual cycles. When activated by emotional stress, the pituitary gland also produces increased amounts of prolactin, and elevated levels of prolactin can contribute to irregular ovulation. The female reproductive tract contains stress-hormone receptors; stress can affect fertility.

However, more complex mechanisms may be at play, and researchers still don’t completely understand how stress interacts with the reproductive system. This is a story that is still unfolding, and during the last 20 years, the new field of psychoneuroimmunology has emerged. This field focuses on how your mind can affect your body. Research has shown that the brain produces special molecules called neuropeptides in response to emotions, and that these peptides can interact with every cell of the body, including those of the immune system.  In this view, the mind and the body are not only connected, but inseparable, so that it is hardly surprising that stress can have a negative influence on fertility.

Stress can reduce sperm counts as well. Testicular biopsy specimens obtained from prisoners awaiting execution (who were obviously under extreme stress) revealed complete spermatogenetic arrest in all cases.

The stress factors that acupuncture addresses stems from both psychological and emotional factors as well as physical ones. For example, extremely painful premenstrual or mid-cycle pain can be debilitating. This type of physical stress no doubt produces emotional stress as a result of missed work, interference in activities, and the pain itself, which in turn can compromise the function of the reproductive system.

The insertion of acupuncture needles has been shown to effectively increase blood circulation. Enhanced blood flow to the reproductive environment clearly improves pregnancy outcomes.

A Diagnostic Window: East Meets West

It is becoming more and more prevalent that research conducted by Western scientists and physicians are highlighting the effectiveness of traditional Chinese medicine. In an article published in the December 2002 issue of the medical journal Fertility and Sterility, the authors reviewed existing evidence regarding the role of acupuncture in the treatment of infertility, and identified a number of studies indicating that acupuncture can increase the success rates of infertility treatments, including IVF.

In a study conducted by Dr. Wolfgang Paulus (Christian-Lauritzen-Institut, Ulm, Germany) and colleagues, half of a group of 160 women who were about to undergo IVF were randomly assigned to receive acupuncture therapy before and after embryo transfer. In the women who received acupuncture, the needles were placed at points believed to influence reproductive factors (for example, by improving blood flow to the uterus).

The acupuncture group had a higher rate of pregnancy compared with those not given acupuncture (43% versus 26%), suggesting that acupuncture can be used to improve pregnancy rates during IVF.

One alternative medicine diagnosis that exists which may be help to explain male or female infertility is called Liver qi stagnation. Key identifiers of an individual with this condition are anger, rage, frustration, depression, and anxiety.

Dr. Secondo Fassino (University School of Medicine, Turin, Italy) and colleagues recorded the personal characteristics of 156 infertile and 80 fertile couples, and measured their degree of psychopathology. When the researchers divided the couples according to the nature of the infertility—organic, functional, or undetermined—they found that anxiety, depression, and a tendency toward anger suppression could predict the diagnosis of organic or functional infertility in women with 97% accuracy. For infertile men, anxiety was also an important independent predictor of functional infertility, increasing the likelihood of having this form of infertility five-fold, while depression was more predictive of organic infertility. However, unlike in women, anger did not appear to influence infertility in men. These results suggest that, beyond the distress that accompanies the failure of repeated attempts to conceive a baby, psychological problems may contribute to functional infertility.

Herbal Medicine

The exact mechanisms of action of herbal medicine intervention are not, at this time, completely understood. However, herbal medicine has been used successfully to treat infertility for thousands of years.               

Practitioners of Chinese herbal medicine rarely use a single herb in treatment. Chinese herbs are formula based; many herbs are mixed together to create the perfect ‘decoction’ specifically designed for the individual patient.

Some formulas contain two herbs and some thirty or more herbs. Each herb has many functions. Each herb has its own flavor, nature, temperature and trophism.  Prescribing the correct herbal medicinals requires extensive training and clinical experience. 

Self-medicating with herbal medicine presents a dual dilemma. At best the herbs will be useless, as the key to correct formula prescription is an accurate differential diagnosis that can only be rendered by a licensed, Board-Certified, experienced practitioner. In the worst case, self-prescribing of herbal medicine may prove harmful.  

One should take herbs only when they’re prescribed by a Board-Certified herbalist. Not only is herbal medicine safe, it is highly effective and free of harmful side effects that often accompany pharmaceutical drugs. There are more than one million hospitalizations per year as a result of drug-induced side effects; not so with herbal medicine.

I have prescribed herbal formulas for 14 years to improve egg and endometrial quality. This is often effective, but, as in all fields of medicine, there is no guaranty of success.  Herbal medicine is also very often used successfully in treating certain sperm anomalies.

The Berkley Center: Treating Fertility Challenges

Clearly, further research is needed to fully understand the mechanisms of action of acupuncture and herbal medicine in treating the infertile patient. Nevertheless, it is my opinion, based on fourteen years of clinical care that the best-case scenario for patient faced with fertility challenges is to offer them every reasonable option which may serve to address their underlying condition. The integration of acupuncture and herbal medicine into the treatment protocol of the infertile patient, from a clinical perspective, based on current scientific and empirical data makes sense.

STUDIES

  1. BMJ  2008;336:545-549 (8 March), doi:10.1136/bmj.39471.430451.BE (published 7 February 2008)

Effects of acupuncture on rates of pregnancy and live birth among women undergoing in vitro fertilisation: systematic review and meta-analysis

Eric Manheimer, research associate1, Grant Zhang, assistant professor1, Laurence Udoff, assistant professor2, Aviad Haramati, professor3, Patricia Langenberg, professor and vice-chair4, Brian M Berman, professor1, Lex M Bouter, professor and vice chancellor (rector magnificus)5

1 Center for Integrative Medicine, University of Maryland School of Medicine, 2200 Kernan Drive, Kernan Hospital Mansion, Baltimore, MD 21207, USA, 2 Department of Obstetrics, Gynecology and Reproductive Services, University of Maryland School of Medicine, 3 Department of Physiology and Biophysics and Medicine, Georgetown University School of Medicine, Washington, DC, 4 Department of Epidemiology and Preventive Medicine, University of Maryland School of Medicine, 5 VU University Amsterdam De Boelelaan 1105, 1081 HV Amsterdam, the Netherlands

Correspondence to: E Manheimer emanheimer@compmed.umm.edu

Objective To evaluate whether acupuncture improves rates of pregnancy and live birth when used as an adjuvant treatment to embryo transfer in women undergoing in vitro fertilisation.

Design Systematic review and meta-analysis.

Data sources Medline, Cochrane Central, Embase, Chinese Biomedical Database, hand searched abstracts, and reference lists.

Review methods Eligible studies were randomised controlled trials that compared needle acupuncture administered within one day of embryo transfer with sham acupuncture or no adjuvant treatment, with reported outcomes of at least one of clinical pregnancy, ongoing pregnancy, or live birth. Two reviewers independently agreed on eligibility; assessed methodological quality; and extracted outcome data. For all trials, investigators contributed additional data not included in the original publication (such as live births). Meta-analyses included all randomised patients.

Data synthesis Seven trials with 1366 women undergoing in vitro fertilisation were included in the meta-analyses. There was little clinical heterogeneity. Trials with sham acupuncture and no adjuvant treatment as controls were pooled for the primary analysis. Complementing the embryo transfer process with acupuncture was associated with significant and clinically relevant improvements in clinical pregnancy (odds ratio 1.65, 95% confidence interval 1.27 to 2.14; number needed to treat (NNT) 10 (7 to 17); seven trials), ongoing pregnancy (1.87, 1.40 to 2.49; NNT 9 (6 to 15); five trials), and live birth (1.91, 1.39 to 2.64; NNT 9 (6 to 17); four trials). Because we were unable to obtain outcome data on live births for three of the included trials, the pooled odds ratio for clinical pregnancy more accurately represents the true combined effect from these trials rather than the odds ratio for live birth. The results were robust to sensitivity analyses on study validity variables. A prespecified subgroup analysis restricted to the three trials with the higher rates of clinical pregnancy in the control group, however, suggested a smaller non-significant benefit of acupuncture (odds ratio 1.24, 0.86 to 1.77).

Conclusions Current preliminary evidence suggests that acupuncture given with embryo transfer improves rates of pregnancy and live birth among women undergoing in vitro fertilisation.

  1. Acupuncture and IVF Study Shows Early Promise for Increased Take Home Baby Rates

Posted on: Tuesday, 12 August 2008, 15:00 CDT

Dr. Paul C. Magarelli, a nationally noted specialist in the field of reproductive endocrinology and infertility, and Dr. Diane K. Cridennda, a recognized authority on acupuncture and Traditional Chinese Medicine, have announced early results of an ongoing study linking acupuncture to positive in-vitro fertilization (IVF) outcomes. The study, which includes the largest-ever participant pool for a study of its kind, explores the increase in take home baby rates associated with combined Eastern and Western medicine treatments.

Drs. Magarelli and Cridennda's ongoing research shows an astonishing 15 percent increase in pregnancies, with a 23 percent climb in actual births in IVF patients treated with acupuncture. In addition, of the 578 patients Magarelli has co-treated at the Reproductive Medicine & Fertility Centers and East Winds Acupuncture from 2003 to 2008, 26 percent more patients became pregnant with acupuncture treatments added to IVF, saving them the costs and heartache of having to repeat an IVF cycle. This savings would decrease the national IVF fertility costs by more than $150,000,000 per year in the United States alone.

"Infertility is a condition that affects more than 7.3 million people nationwide, and many of those couples are unaware of the potential that acupuncture holds for them," said Dr. Magarelli. "Our study demonstrates that acupuncture increases uterine blood flow, reduces stress and has an overall positive impact on our IVF patients. And the results really speak for themselves: one of every four of our patients who have used acupuncture in conjunction with IVF has not had to repeat an IVF cycle to create their families."

A three-part exploration of Drs. Magarelli and Cridennda's ongoing breakthrough acupuncture and IVF study will be published in Fertility Today magazine later this year. ABOUT DR. PAUL C. MAGARELLI

Dr. Paul Magarelli, MD., Ph.D., a member of the GENESIS Network for Reproductive Health (www.genesisivf.com), recently won the Practicing Physicians Award from the Pacific Coast Reproductive Society for his groundbreaking research on the impact of acupuncture on IVF pregnancies. Not only is he known for his instrumental work in creating new pricing structures to provide cost-effective, competent IVF care for the average wage earner, but he is best known to his patients for applying high-tech procedures with a personal touch. In addition to co-founding the Corona Institute for Reproductive Medicine & Fertility, he is the medical director of the Reproductive Medicine and Fertility Centers in Colorado and New Mexico, where he specializes in infertility and all aspects of hormonal pathology in women. Dr. Magarelli has been interviewed as an expert source for MSNBC, Fertility & Sterility and PregnancyandBaby.com. To learn more, visit www.ColoradoSpringsIVF.com and www.CoronaFertility.com.

ABOUT DR. DIANE K. CRIDENNDA

Diane K. Cridennda, L.Ac., (FABORM) is Board Certified in the field of Reproductive Oriental Medicine. She graduated from the International Institute of Chinese Medicine in l995 with her Masters of Oriental Medicine degree. She trained in Beijing, China to explore the root of this ancient healing art. She is NCCA certified, licensed in Colorado and is a member of Resolve, a national infertility support group. She has also had extensive training in Traditional Chinese Herbal Medicine. For more than seven years, Diane has been working with Reproductive Endocrinologists using a combination of Eastern and Western medicine therapies for the treatment of infertility. To learn more, visit www.EastWindsAcupuncture.com.

  1. Fertility & Sterility Journal Volume 85, Issue 5, Pages 1347-1351 (May 2006)

Bottom of Form

Effect of acupuncture on the outcome of in vitro fertilization and intracytoplasmic sperm injection: a randomized, prospective, controlled clinical study

Top of Form

Stefan Dieterle, M.D.aCorresponding Author Informationemail address, Gao Ying, M.D.ab, Wolfgang Hatzmann, M.D.a, Andreas Neuer, M.D.a

4.      Can acupuncture boost my fertility?

Skrivet för BabyCentre UK

The BabyCentre Editorial Team svarar:

Research suggests that acupuncture may be helpful to couples undergoing in-vitro fertilisation (IVF), but the verdict is still out on whether it can improve fertility in general. Although smaller studies show promising results, more research is needed before we can say for sure that this age-old therapy can help you get pregnant.

Acupuncture is based on the theory that vital energy (or "qi," pronounced "chee") flows through the body along certain pathways. Acupuncturists try to balance this energy and restore health by stimulating specific points along the pathways with thin needles. Although it has been a staple of Chinese medicine for some 5,000 years, acupuncture has only gained acceptance in the Western medical community in the past few decades.

In 2002, a team of German researchers discovered that acupuncture significantly increased the odds of pregnancy among a group of 160 women who were undergoing IVF treatment. Forty-two per cent of the women who received acupuncture got pregnant, compared to 26 per cent of those who didn't receive the treatment.

Since then, more research has given support to the benefits of acupuncture for women undergoing IVF. One study, also in Germany, reported that conception and ongoing pregnancy rates were higher for women who had acupuncture treatment in the the second part of their menstrual cycle (the luteal phase) following IVF or ICSI. While a Danish study found that conception rates were best improved by having an acupuncture treatment on the day the embryos were transferred into the uterus. Their findings showed that having an additional acupuncture treatment two days later did not improve the chances of conception or ongoing pregnancy.

So how does it work? Nobody really knows, but researchers think that acupuncture may help increase blood flow to the uterus and relax the muscle tissue, giving the embryos a better chance of implanting.

Acupuncture may also help male infertility. Regular treatments have been shown to improve sperm counts and motility (the strength with which the sperm swim) for men with fertility problems but not always significantly. To improve the chances of pregnancy by natural means, acupuncture treatment would need to increase a man's sperm count over the threshold needed for conception. This means a minimum of 10 to 12 million moving sperm per ejaculate, and the men in these studies didn't get up to those levels.

However, for couples considering assisted conception, acupuncture can help by improving the quality of the sperm. In a study published in 2005, researchers analysed sperm samples from men with infertility of unknown cause before and after acupuncture treatments. They found that acupuncture was associated with fewer structural defects in sperm and an increase in the number of normal sperm.
 

Most experts believe that we need larger and better studies, ideally random and double blind trials, using fake needles for some patients and real ones for others, in order to really know whether acupuncture is effective. In some of the studies mentioned above, the patients and healthcare providers knew that acupuncture was performed, so the studies weren't "blind" and the success of the treatment might have been due to what's known as the placebo effect. Perhaps it was the patients' belief in acupuncture, rather than the acupuncture itself, that accounted for the treatment's success.

However, in the end it doesn't matter that much whether the success of acupuncture is a placebo effect or not. The bottom line is that acupuncture is relatively safe, and if it improves fertility, even if it's only because you think it does, it may be worthwhile.

The best first step to treating any fertility problem is to contact a specialist. If you do decide to try acupuncture, look for a registered acupuncturist, some of whom are also medical doctors. The British Acupuncture Council (www.acupuncture.org.uk) can help you find one near you.

Reviewed May 2007

Sources

Chang R, Chung PH, Rosenwaks Z. 2002. Role of acupuncture in the treatment of female infertility. Fertil Steril. 78(6):1149-53

Dieterle S, Ying G, Hatzmann W, Neuer A. 2006. Effect of acupuncture on the outcome of in vitro fertilization and intracytoplasmic sperm injection: a randomized, prospective, controlled clinical study. Fertil Steril. 85(5):1347-51.

Paulus WE, Zhang M, Strehler E, El-Danasouri I, Sterzik K. 2002. Influence of acupuncture on the pregnancy rate in patients who undergo assisted reproduction therapy. Fertil Steril, 77(4):721-4

Pei J, Strehler E, Noss U, Abt M, Piomboni P, Baccetti B, Sterzik K. 2005. Quantitative evaluation of spermatozoa ultrastructure after acupuncture treatment for idiopathic male infertility. Fertil Steril, 84(1):141-7

Siterman S, Eltes F, Wolfson V, Lederman H, Bartoov B. 2000. Does acupuncture treatment affect sperm density in males with very low sperm count? A pilot study. Andrologia, 32(1):31-9

Siterman S, Eltes F, Wolfson V, Zabludovsky N, Bartoov B. 1997. Effect of acupuncture on sperm parameters of males suffering from subfertility related to low sperm quality. Arch Androl, 39(2):155-61

Westergaard LG, Mao Q, Krogslund M, Sandrini S, Lenz S, Grinsted J. 2006. Acupuncture on the day of embryo transfer significantly improves the reproductive outcome in infertile women: a prospective, randomized trial. Fertil Steril. 85(5):1341-6

Zhang M, Huang G, Lu F, Paulus WE, Sterzik K. 2002. Influence of acupuncture on idiopathic male infertility in assisted reproductive technology. J Huazhong Univ Sci Technolog Med Sci, 22(3):228-30

 

 

Multiple Miscarriage, Infertility and the Use of Herbal Medicine

Herbs used in Alternative or Complementary Medicine

by Mike Berkely

Herbs used in Alternative or Complementary MedicineBoth anticoagulants and antiplatelet mitigators are medicines that reduce blood clotting in an artery, a vein or the heart.

Heparin and Lovenox are anticoagulants and aspirin is an antiplatelet.  Antiplatelets such as aspirin decreases platelet aggregation and thrombus formation. They are mostly used in problems with arterial circulation where anticoagulants have little effect.

Anticoagulant medications make the blood 'thinner' and prevent the formation of blood clots and hence could prevent stroke. Both anticoagulants and antiplatelet medications have been used to treat chronic recurrent miscarriage due to thrombophilic disease.

There are several herbal medicines which possess antiplatelet and anticoagulant properties.
Jiang Huang and Yu Jin are herbs that possess antiplatelet properties. Chuan xiong has both anticoagulant and antiplatelet properties.

I am not recommending that a patient with a thrombophilic presentation use herbs instead of Western medicine which possess the required qualities necessary to prevent miscarriage via anticoagulant or antiplatelet activity. Sometimes however, a drug does not possess the same qualities of an herb. An herbal formula, for example, has a multitiered effect. The correct formula might for example, be used to reduce inflammation, reduce platelet aggregation and/or reduce coagulopathies as well as reduce stress, strengthen the immune function and help facilitate weight loss in an obese patient. All of these things would be required in a patient of this type to increase the odds of a successful on-going pregnancy; not just Heparin or Lovenox or Aspirin. This is important to consider in case you miscarry even when taking these types of meds.

A patient may need more intervention than these traditional Western medications are capable of providing.

Patients should follow the instructions of their reproductive endocrinologist  However, in the face of failure with traditional Western medical approaches, trying herbs may help contribute to a full term pregnancy. In my practice I have seen this occur multiple times.

Many patients faced with the difficult challenge of trying to conceive or who recurrently miscarry are instructed by their reproductive endocrinologists not to take herbs. This is because their doctor is trying to protect the patient. Western trained physicians with no education in Chinese medicine typically may not feel comfortable mixing Western medical techniques and practices with herbs. It is my experience and training in Chinese medicine as a board certified heralist that herbs can complement Western medications and patients who otherwise lost pregnancies can carry to term.

Herbs do not reduce the effectiveness of the medications nor, in most cases increase the potency. The only exception to this would occur herbs were prescribed in conjuction with medication that have anticoagulant/antiplateleet properties such as Lovenox or Heparin. This could present a potentiating and possibly dangerous effect.

Acupuncture can increase metabolic function and stimulate the flow of blood throughout the body. Increasing hemodynamics is not, however the same as actually reducing platelet aggregation or reducing hypercoagulation.  The benefit of using acupuncture with herbs is that the acupuncture will help ensure the distribution of the herbs throughout the body.

Typically when Western medical techiques for treating infertility and recurrent pregnancy loss fail, is to combine acupuncture, herbs and Western medicine to create a synergistic and complementary affect.

When seeking to use herbal medications be certain that a board certified herbalist is prescribing.

Email Mike.  Visit the Healing Arts Complementary Medicine Forum.

 

 

 

Use of Complementary Medicine for Miscarriage Prevention

by Mike Berkley, L.Ac,

A New Protocol Developed by Mike Berkley to Help Prevent Miscarriage

For many years I never needled the abdomen of a pregnant woman for fear of causing miscarriage. This method of behavior stems in part from fear of over-stimulating blood flow to the embryo or placenta. This thinking, as I have recently discovered, is incorrect. It has taken me ten years of study and research to enable me to fully understand what is happening in the uterus after a successful pregnancy and why abdominal acupuncture for the first three months of pregnancy is not only safe but serves significantly to prevent miscarriage.

At the luteal phase or secretory phase of the menstrual cycle the predominant hormone is progesterone. Progesterone is created from the follicle that has ovulated the mature egg. This follicle is now known as the 'yellow body' or corpus lutuem. The corpus luteum, under the influence of luteinizing hormone which emanates from the anterior pituitary in the brain secretes progesterone. This action is done to enable the uterine lining to be amenable to a successful embryo implantation and pregnancy. If pregnancy is not successful, the corpus luteum becomes atretic (dies) and progesterone levels diminish and menstruation starts.

When a woman does successfully become pregnant, the LH which is required to maintain high levels of progesterone (P) no longer comes from the anterior pituitary gland in the brain. It comes in fact, from the developing blastocyst itself. The blastocyst (developing baby), secretes HCG or Human Chorionic Gonadotropin which has a very similar molecular structure to LH. The HCG causes the corpus luteum to continue to secrete P (this is called corpus luteum- rescue), until the placenta is fully formed at which point the placenta itself secretes appropriate amounts of P to help maintain pregnancy.

So, if the developing blastocyst is responsible for secreting HCG to keep itself alive it made sense to me to use very few and well placed needles in the abdomen to gently stimulate blood flow to the blastocyst so that P would continue to be secreted from the corpus luteum.

This, in my opinion is one of the major ways that miscarriage prevention can be achieved with acupuncture. I am the first one to arrive at this idea and have been using it with great success.  My protocol consists of using acupuncture twice weekly for 13 weeks after IUI, IVF or donor-egg or after a natural pregnancy is confirmed. The majority of miscarriages occur within the first twelve weeks of pregnancy. Our goal is to take the patient one week outside of the danger zone; this is why we treat for 13 weeks and not 12.

After 6 or 7 weeks the placenta is formed and it secretes P. The corpus luteum is no longer necessary. But, one of the major causes of miscarriage is inappropriate blood flow to the placenta. One of the causes of this is due to thrombophilic disorders (The tendency to form blood clots).  But clinically what does this mean? Blood carries oxygen, hormones and nutrients to the placenta and excretes dead cells from it.

These dead cells are called 'debris'. By continuing to use abdominal acupuncture, we continue to gently stimulate  blood flow to the placenta (reducing the effects of poor hemodynamics which can occur due to thrombophilic disorder or just poor circulation), maintaining its ability to secrete P, estrogen, human placental-lactogen, relaxin and other hormones necessary for the maintenance of a healthy pregnancy.

I am constantly studying Western reproductive medicine and translating my findings into a Chinese medical model which serves to increase a useful knowledge-base to help couples achieve pregnancy. However, achieving pregnancy is only half the battle. The other half is maintaining a healthy pregnancy.  The focus of many acupuncturists is to help their patients become pregnant. This too is my first goal, but only my first. My second goal is to maintain a viable pregnancy and this is where my research and studies are now taking me.

This new Berkley Center protocol is working wonders for those suffering with repeated pregnancy loss, as well as those who have had difficulty in conceiving.

Acupuncture treatment for the infertile patient as well as the patient suffering with repeated pregnancy loss must be continued after pregnancy is achieved to increase the odds of a successful, full-term pregnancy.  Treatment should be continued for thirteen weeks, as 90% of miscarriages occur within the first trimester.

Mike Berkley, L.Ac., FABORM

Mike will answer your questions live on the Healing Arts Complementary Medicine Forum
 

 

Improving Egg Quality

Improving Egg Quality with the Use of Mitochondrial Nutrients

Improving Egg Quality with the Use of Mitochondrial NutrientsImproving Egg Quality
(Supplementation with Mitochondrial Nutrients)
By Mike Berkley

Supplementation of mitochondrial nutrients may improve the availability of energy production for the maturing oocyte and the developing embryo and thus reduce aneuploidy and assist in clinical pregnancies and live birth rates.

Ovulation leads to resumption of meiosis in the oocyte. This means that there is an alignment and separation of chromosomes by the nuclear spindle. The mature oocyte then contains 23 chromosomes. 23 chromosomes are isolated outside of the zona- pellucida in the first polar body. When penetrated by a euploidic sperm a second polar body is extruded and the zygote then has a normal diploid complement of 46 chromosomes. The process of extruding chromosomes outside of the oocyte as well as expulsion of the second polar body requires energy.

The energy required for metabolic function of the oocyte is provided by mitochondria and ATP. The egg has more mitochondrial cells than any other tissue in the body. During recruitment of follicles mitochondrial DNA increases from 6000 copies to about 200,000.

Mitochondrial DNA is very vulnerable to mutations and deletions. The inheritance of mitochondrial DNA is strictly maternal. We can see from a TCM perspective that this is a clear depiction of yang within yin since the absence of the female’s yang qi would mean a complete lack of mitochondria/ATP. Mitochondria is where the power cells, ATP are stored. As a woman ages her mitochondrial function (yang qi) declines and, as a result there are mutations and deletions in the nucleotides which is where mitochondrial DNA is stored.

Oxidative phosphorylation is a metabolic pathway that uses energy released by the oxidation of nutrients to produce adenosine triphosphate (ATP). Although oxidative phosphorylation is a vital part of metabolism, it produces reactive oxygen species such as superoxide and hydrogen peroxide, which lead to propagation of free radicals, damaging cells and contributing to disease and, possibly, aging (senescence). Free radicals are harmful to egg and sperm quality.

One of the more frequent nucleotide deletions is the “common” deletion of 4977 base pairs, almost a third of the whole mitochondrial DNA genome. This deletion was shown to have a high prevalence in unfertilized oocytes and oocytes from older patients. As women and eggs age, mitochondrial energy production diminishes. Many processes of oocyte maturation especially nuclear spindle activity and chromosomal segregation become impaired.

It appears that free radicals along with reduced ATP and mitochondrial anomalies cause follicular damage and aneuploidy in the older woman.
 

Supplementation of mitochondrial nutrients may improve the availability of energy production for the maturing oocyte and the developing embryo and thus reduce aneuploidy and assist in clinical pregnancies and live birth rates. There are two ways to supplement these nutrients; exogenously and endogenously. For example, exogenous supplementation with Coenzyme Q10 helps to create ATP. It is also a major antioxidant. Natural systemic CoQ10 decreases with age.
 

An endogenous means of supplementation has less to do with directly affecting the function of the ovaries than improving systemic function so that ovarian function will improve naturally.

In order for a family to function in a healthy fashion all members of the family must be healthy. Let’s look at this statement from a different perspective: if one family member is sick, it will affect the others members of the family, either physically, emotionally or both. So the family dynamic must be treated; not just the sick individual. This is a more organic and holistic approach to treating the root and not the branch or the etiology as opposed to the symptoms. This is the goal of endogenous supplementation with, for example, herbal medicine.

An herbal formula that may be used to treat poor egg quality endogenously, due to yin-essence vacuity with depletion of yang might be composed of:

Xiang fu, dang gui, bai shao, shu di, rou cong rong, rou gui, shan yao, dang shen, mai dong and lu rong.

Of course, a formula must be created based upon a differential diagnosis and must strictly follow a treatment principle but this formula elucidates the pathology being treated: yin-essence vacuity with yang qi depletion.

There are two herbs, dang gui and xiang fu which will help ‘move’ the other herbs so stagnation will not occur but dissemination will. There also two herbs to help benefit the kidneys through supplementation of the spleen qi; shan yao and dang shen. Mai dong is used to benefit metal so as to promote water. Rou cong rong, rou gui and lu rong warm the kidneys, promote yang and benefit essence.

These methods of treatment involving benefitting the kidneys through supplementation of the spleen qi and benefitting metal to promote water; are referred to as treating ‘one step removed’. In other words we don’t just treat the organ or channel involved but we also treat organs that have a direct effect on other organs. It’s similar to using lung acupuncture points as part of a protocol to positively affect the large intestine.

Aging is a natural process and in the present culture health-care providers are often faced with the challenge of trying to reverse the reproductive clock with assisted reproductive interventions. These techniques such as IUI and IVF are often successful but more often they are not.

The main reason that ART fails more than it succeeds is because ART is primarily a mechanical process which cannot improve the components required to facilitate a clinical pregnancy and a live birth – egg and sperm.

Though CoQ10 has shown promising results, it still is not a full system approach. In other words it works on egg and sperm but not lining and other presentations which can alter the perfect balance, integration and function of the entire body to allow for pregnancy.

 

Acupuncture and herbal medicine are less involved per se in improving one area of function but more to the point, they improve all systems and functionality of the human organism –psycho-emotionally and physically.

Let’s use an analogy. If you lived in a rickety old house which was literally falling apart and it had very drafty windows you could spend $20,000.00 replacing the windows with state-of-the art windows and the drafts would be gone. But the house would fall apart anyway in a short time. In order for the house to be healthy the entire house must be addressed, not just the windows. IUI and IVF are really just dealing with the windows. TCM rebuilds the house.

The lungs, spleen and kidneys are the primary organs which, according to the theory of TCM, contribute to the creation and dissemination of energy or qi in the human being. As a person grows older their aerobic capacity decreases, their digestion worsens, their lower back and knees weaken, and their sexual and urinary functions worsen. That’s because these named organs are becoming deficient in qi which is a natural part of aging. If these organs could be nurtured, supplemented, and regulated their functionability may improve.

Improvement would be witnessed as improvement in the functions associated with each organ that I mentioned above. However, these three organs have far greater responsibility than that which is associated with the organs themselves. Egg quality, sperm quality, lining quality and the emotional state can all be improved with their respective improvement.

Then, when an IVF ET is performed the products (egg, sperm and endometrium) that the REI are mechanically manipulating will be superior in health and have a higher possibility of manifesting in a live birth.

The best outcomes for pregnancy and live births will come not from improved IVF techniques or more powerful drugs to facilitate greater folliculogenesis but through the improvement of the quality of the necessary components to achieve pregnancy: sperm, egg, and lining along with the down-regulation of pathogenic factors that can mitigate fertility such as immunological factors, blood clotting factors and inflammatory processes (endometriosis without pelvic distortion for example).

Acupuncture and herbal medicine has been effective in treating many cases of infertility for more than two thousand years.

When East meets West in the clinic, then patients will have the best chance of turning their dreams of having a family into a reality.

Mike answers questions on the INCIID Healing Arts Forum. He is an INCIID Advisory Board member and the director and founder of the Berkley Center in NYC.
 

The Truth about Herbal Medicine

By Mike Berkley, LAc.

Chinese herbal medicine has been used for more than 3000 years to treat various types of pathological presentations including infertility. The main difference between acupuncture and herbal medicine is that acupuncture helps to move energy and improve blood flow throughout the body in general and to specific areas in particular. If for example, one is trying to improve ovarian health and egg-quality, acupuncture can be used to drive blood to the ovaries, generally improving their function and making them more responsive to gonadotropins.

Herbal medicine however actually affects system function. Herbs help to stimulate and nourish what is deficient (low platelet count) and to eradicate what is in excess (elevated androgen levels). Many reproductive endocrinologists do not want their patients to take herbs. The following two reasons are usually given:

1. “Herbs lower fsh falsely because they contain phytoestrogens.” This misinformation would only be accurate if the herbs lowered fsh, and the patient’s estrogen levels rose above 65pg/ml. The fact remains that many patients have their fsh levels regulated with herbal medicine in the context of an estradiol level which remains between 25pg/ml to 65pg/ml.

2. “Herbs can interfere with reproductive medicine.” This is not true.  Herbs actually work synergistically with reproductive medicine. For example, many patients are poor responders to gonadotropins but, when gonadotropins are used in conjunction with herbs the response is frequently improved.

The main reason that your doctor does not want you to take herbal medicine is because she or he is trying to protect you against what they perceive to be a health hazard which may occur as a result of the herbs. Of course these herbs when prescribed by a Board Certified herbalist are completely safe. Health hazards do not occur as a result of taking herbs anymore than health hazards occur as a result of taking Lupron or Gonal-F.

Your doctor should be commended for his or her responsible behavior towards their patient, but, unfortunately their information comes from not having the information; in other words, ignorance.

This attitude may also be manifested by practitioners of Complementary medicine. Many Complementary medicine doctors frequently advise their patients to stay away from IVF or IUI procedures because the “drugs will be harmful.” Of course this is utterly untrue. Once again, it comes from a position of ignorance. Western reproductive medical intervention is efficacious and safe. Think about this: when was the last time that you heard of someone being hospitalized or dying from herbal medicine which was prescribed by a Board Certified herbalist? I have never heard of such a case.

 

 

Mike Berkley - Complementary Medicine, Acupuncture and Herbal Medicine

Mike Berkley, L.Ac.
Founder and Director,
The Berkley Center for Reproductive Wellness

Mike Berkley, Founder and Director of The The Berkley Center for Acupuncture & Herbal Medicine in New York City, is licensed and Board Certified in Acupuncture in New York State. Mike is also certified in Chinese Herbology by the National Certification Commission for Acupuncture and Oriental Medicine.

Mike graduated from The Pacific College of Oriental Medicine in New York in 1996, and he has been treating reproductive disorders since then. Mike is the first acupuncturist/herbalist in the United States to work exclusively in the field of reproductive medicine

He works exclusively in the area of reproductive medicine and enjoys working in conjunction with some of New York’s most prestigious reproductive endocrinologists.
 

TELEVISION AND RADIO APPEARANCES
1997   Dr. Robert Atkins Radio Show, WEVD, New York, NY
1997   News All Day, NY1-TV, New York, NY
2002   Today in New York, WNBC (NBC), New York, NY
2002   Live With Regis & Kelly, WABC-TV (ABC), New York, NY
2002   The Early Show, WCBS-TV (CBS), New York, NY
2004   Interviewed on WHLV Talk Radio, Buffalo, NY
2006   WBAI - Global Medicine Radio. Interviewed by Dr. Kamau Kokayi
2006   Interviewed on the ROSHOW with Rolanda Watts
2007   Karma Radio, Myths and Realities of Infertility
2007   Conceive On Air, Talk Radio with Kim Hahn
2007   Interviewed on WWOR-TV Channel 9 News by Tena Ezzeddine

Mike Answers your questions on the Hearling Arts Complementary, Acupuncture and Herbal Medicine Forum here on INCIID!

 

Uniting as a Couple to Beat the Holiday Stress

UNITING AS A COUPLE TO BEAT HOLIDAYSTRESS

by Helen Adrienne, MSW, ACSW, BCD

 

 

 

Infertility is stressful; the holidays are stressful. Taken together, one plus one equals way more than two. Yet just as the Chinese character for crisis is a combination of the characters for danger and opportunity, the crisis of infertility can present an opportunity to turn to the marital relationship as a refuge from holiday stress.

 

It is no longer in dispute that both the mental and physical experiences of stress land in the body. That’s about the last thing that an infertility patient needs. Your body is the stage upon which the drama of treatment gets played out. Being poked and prodded physically evolves very naturally into a mental ordeal. And in this society, many of us are already living in a state of red alert, tolerating high levels of stress.

 

At holiday time, tensions abound even in the best of families. The backdrop for get-togethers may have to do with who expects what, who can’t stand whom, whose house is center stage, whose traditions “win,” who’s impossible to buy presents for and who’s jealous of what. And of course, a sharp and very long thorn is who’ll be present at celebrations with babies. The who’s whose and what’s go on ad nauseum.

 

This does not mean that all families are Looney Toons. It does mean that families can’t ever be perfect, and you are not likely to be in the mood for anyone’s imperfections. Often, well-meaning people who know about your struggle do not know what to say and say the wrong thing. If they don’t know, keeping the secret creates additional stress for you.

 

Infertility may be the first crisis of major proportions that has hit you in the time that you’ve been together. Any crisis will demand that a person locate his or her coping methods, and infertility might put you in a spin if you need better coping mechanisms. It is only the rare couple whose coping mechanisms are congruent at the time a crisis hits.

 

The holiday opportunity for any couple lies in the fact that it is critically important to be on the same page when it comes to making decisions about how to handle the holidays. You may already be supportive of one another; most couples are. But there is a difference between the general support that flows out of compassion for someone you love and the achievement of a united front, which works best.

 

Whether on your own or with professional help, successfully deciding and declare your decisions about the holidays will help to minimize the impact of family holiday stress on your bodies. It may feel dangerous to set limits to holiday celebrations with one or both families. But it is very important for any couple to define their “coupleness.” As married adults, it is your job and your right to let both families know what your boundaries are. It is highly recommended that if you cannot get past the pull of your families, you seek the guidance of a therapist with skills in both infertility counseling and family counseling.

 

Beyond the logistics, now is the time to explore holiday activities and techniques of mind/body relaxation that you can enjoy together. Being on the same page, and feeling loved and understood, is palliative. 

 

As hectic as the holiday time can be, it would make a difference if you could find a nonsexual way to release physical stress together. Perhaps you can locate a yoga or massage class for couples, or go to a spa together for a weekend. Couples can learn methods of breathing, muscle relaxation, mindfulness meditation and self-hypnosis that go a long way toward breaking the grip of the infertility challenge from the inside out. These techniques are extremely empowering at a time when couples tend to feel powerless. By focusing on gaining physical relief from tension, you can break the grip that the infertility challenge has on your bodies.

 

Infertility is nasty. But the silver lining in the clouds is that as a couple, you can and should put your needs front and center. You need to keep your love alive, for each other and for yourselves. The best way to do this is to acknowledge the enormous stress involved and take the opportunity to learn to communicate so you can land on the same page. And you can pursue the myriad of techniques available these days to reduce stress on the body and the mind.

 

HELEN ADRIENNE, MSW, ACSW, BCD, is a PSYCHOTHERAPIST and PRACTITIONER OF MIND/BODY MEDICINE in private practice in New York.

 

Acupuncture and Traditional Oriental Medicine to Enhance Fertility

Acupuncture and Traditional Oriental Medicine  To Enhance Fertility

Randine Lewis, Ph.D. L.Ac. and Susan Fox, M.S., L.Ac.

 

 

Although Chinese medicine has been used to address fertility for thousands of years, only recently has acupuncture received notable press in the West for its ability to address fertility issues. In the 1990’s the World Health Organization of the United Nations first publicly recognized acupuncture’s therapeutic effect to overcome infertility. Following behind, a Swedish study noted acupuncture’s ability to improve ovarian blood flow and increase pregnancy rates. And in Germany a study verified acupuncture’s ability to improve embryo implantation rates. Because of this, there has been a trend toward utilizing acupuncture, either alone or in conjunction with other advanced fertility methods, to support the journey to pregnancy or parenthood.  Some of the most cutting edge reproductive clinics in the West have begun to study Chinese medicine and incorporate acupuncture treatments to increase pregnancy rates. Acupuncture is but one tool in the entire system of Traditional Oriental Medicine, which relies upon a proper individual diagnosis, and also includes herbal medicine, lifestyle and nutritional counseling, QiGong and meditation.  

 

Acupuncture is a system that identifies energy pathways in the body, which are referred to as meridians. There are twelve meridian systems that traverse every tissue of the body.  Stimulation of acupuncture points has a regulatory effect on the nervous, circulatory and endocrine systems, reducing the tendency to be in hypersensitive Sympathetic (flight or fight) state, and shifting energies toward the Parasympathetic (rest and cleanse) system.  Acupuncture alone can regulate the hormones, restoring menstrual regularity. Acupuncture points are identified for specific health issues, and an acupuncture prescription is designed to address an individual’s unique presentation of symptoms.  This is particularly evident, for example, when two patients with the same conventional diagnoses will present with distinctly different symptoms. 

 

Our “flight or fight” response directs blood flow to our extremities, which impedes circulation to our detoxification and reproductive systems.   Acupuncture and abdominal massage (referred to in Traditional Oriental Medicine as Chi Nei Tsang) help redirect our energies and provide nutrition via increased circulation to our reproductive organs.   Patients frequently experience a deep sense of relaxation while undergoing acupuncture treatment. which is the very source of balance they are seeking during the oftentimes stressful periods of focusing on fertility challenge.

 

A significant component of healing that occurs for patients undergoing acupuncture for fertility care results from the degree of intimacy that Traditional Oriental Medicine incorporates into its methods in inquiry and treatment. Because our system does not separate the emotional and spiritual “bodies” from the physical, we are often able to address these aspects as part of the whole person’s imbalance.  This can be viewed from the physical effects; i.e., how acupuncture can positively affect the hypothalamus -> pituitary -> ovarian axis, or it can be viewed holistically; i.e., attending to the emotional body of the person(s) undergoing a life challenge.  Certainly, should the mind/body inquiry reveal the need for psychotherapeutic intervention, one should be prepared to address such issues with a licensed psychotherapist. 

 

Beyond the clinical setting, there is a wonderfully supportive program entitled The Fertile Soul, which holds retreats for women and couples experiencing challenges with fertility.  Randine Lewis has developed a healthy, supportive retreat system that empowers attendees to understand and recapture their innate creative potential, develop lifestyle choices to prepare for and support family building and to heal patterns that do not serve their life’s goals.

 

To find an acupuncturist whose specialty is in the area of fertility, contact The Fertile Soul’s Clinical Excellence in Fertility practitioners at www.thefertilesoul.com.

 

Ovarian Cryopreservation by Michael Opsahl, MD

Ovarian Cryopreservation 
by Michael S. Opsahl, MD 

 
Cryopreservation of ovarian tissue is a technique to bank oocytes (eggs) in situations where the woman may lose all her eggs from a medical treatment, disease process or even the natural loss from natural aging. Potential uses for this technique include restoring fertility and normal ovarian hormone production without the use of medications. The technique of ovarian tissue cryopreservation and transplantation of the thawed tissue is experimental. Since the first significant publication on ovarian tissue cryopreservation and transplantation in 1994(1), over 100 publications attest to the scientific interest in this technique or treatment strategy.(2-36)

Background

Several diseases and their treatments threaten to destroy all the eggs in a woman's ovaries. Diseases rarely have a direct effect on the eggs in the ovary. Exceptions include genetic disorders such as women with a single X chromosome (Turner Syndrome) or women missing a specific piece(s) of an X chromosome, in which case the eggs die quickly and the women have premature menopause. Chemotherapy or radiation used to treat cancer or some non-cancerous disorders have the unfortunate side effect of destroying the eggs in the ovary as well as the diseased cells.

Unlike sperm production in men which is continuous, women are born with all their eggs and they do not produce any more. The natural process of each menstrual cycle consumes approximately 500-1000 eggs until the supply is exhausted (about age 51, menopause). Any treatment that accelerates the loss of eggs threatens to decrease fertility and will cause menopause at an earlier age than expected. Surgery to remove all or a portion of one or both ovaries, some chemotherapy (cyclophosphamide, doxorubicin, vinblastine, etc.), and radiation therapy all have known toxic effects on eggs. The number of eggs that die from these treatments depends primarily on the agent(s), the dose, and the age of the woman when treated. The higher the dose and the older the woman, the more likely that most eggs will be lost and that menopause will occur.

Men have been able to cryopreserve (freeze) their sperm for decades. However, women have not been able to freeze their eggs reliably because the eggs are hard to retrieve and unfertilized eggs have generally not survived freezing. With the advent of IVF, egg or embryo freezing became possible. IVF has several significant limitations. IVF takes time to complete since the hormones used to stimulate the ovary are administered at specific times of the menstrual cycle and then are administered for 2-4 weeks. Many cancer patients must begin their cancer treatment before IVF can be completed. Many cancer patients are young and unmarried; therefore, they do not have a partner to provide sperm to fertilize the eggs. Cryopreservation of unfertilized eggs is an alternative that has gained interest with newer freezing techniques and there are successful pregnancies. Further, IVF is medically inappropriate for many women with hormonally responsive tumors such as breast cancer. The ovaries can be surgically moved from the field of radiation in selected cases but this technique does not help women with chemotherapy.

Ovarian hormone suppression (gonadotropin releasing hormone agonist) during chemotherapy significantly protected human eggs in one research study. Follow-up studies by other centers and with larger numbers of women will clarify the value of this approach. Gonadotropin releasing hormone agonist administration is inexpensive, relatively safe and unlikely to compromise other treatments; therefore, it deserves serious consideration despite limited data on its effectiveness. Donor eggs, for those women who have irreversible ovarian failure, provide very high rates of successful pregnancies, if other options fail.

Perhaps the largest group of women who may benefit from egg banking, are those women who delay child-bearing, for whatever reason, until the late thirties or forties. It is widely recognized that female reproduction becomes progressively more inefficient with advancing age and pregnancies are quite rare by the mid-forties. Whether, egg banking at an early age will be practical or effective remains speculative.

For all these reasons, a technique to bank eggs would allow women to have the same reproductive options as men when faced with a serious disease that threatens to destroy their eggs.

 

Dr. Roger Gosden's published paper in Human Reproduction in 1994 demonstrated the ability to cryopreserve ovarian tissue, transplant it after thawing and obtain functioning ovarian tissue that led to successful births of healthy animals.(1) His team also demonstrated long-term functioning of transplanted cryopreserved ovarian tissue for about two years in sheep.(21) The fertility rate after ovarian cryopreservation in mice was approximately 50 - 75% after ovarian tissue autotransplantation.(27;33) Human tissue was viable after transplantation into a mouse model.(9;15;29) Whether human results will be as successful as animal results will require time and experience. Consequently, until clinical trials demonstrate the viability of this technique, ovarian tissue cryopreservation and transplantation must be considered highly experimental.

Based on preliminary animal data, human trials of ovarian tissue cryopreservation began in 1995.(30) These ongoing trials have produced limited human data since humans often require many years to be free of cancer, or they may not have partners and may not be ready for pregnancy.

 

Techniques

Ovarian tissue cryopreservation begins with laparoscopy or mini-laparotomy. Ordinarily, the surgeon removes only one ovary to allow normal ovarian hormone production from the other ovary during treatment and because the woman may have ovarian function after treatment of her disease. The laboratory staff portion sections the ovarian cortex (which contains the eggs) into thin tissue slices. The tissue slices are cryopreserved at -196°C using specialized cryoprotectants and controlled-rate freezing equipment.

When the woman and her physicians feel fertility is appropriate, transplantation of the ovarian tissue strips can be attempted. 

In animals and humans, frozen ovarian slices have a high survival rate after thawing. The location for tissue transplantation could be in the abdomen near the fallopian tube to allow natural ovulation and conception. Natural conception occurred in all animal studies. The ovarian tissue began to function within several months after transplantation. The disadvantage of transplantation into the abdominal cavity is limited access, potentially lower viable tissue since ingrowth of blood vessels occurs primarily from only one side of the tissue, and adhesion formation (scar tissue) during the recovery period after surgery.

Recently, transplantation of human ovarian tissue into the forearm resulted in follicle formation and egg retrieval with a needle. Parathyroid tissue transplanted into the forearm routinely functions normally in patients with other medical disorders. The forearm is well-vascularized, easy to access, and is a site with little surgical risk. Consequently, because the ovarian tissue is surrounded with vascularized tissues, it may have a greater probability of short and long-term function. Transplantation of tissue into the forearm precludes natural conception. Assisted reproduction with IVF using eggs retrieved from the arm would necessarily be applied. Risks Surgery is necessary to remove the ovary. Despite routine surgical and anesthetic techniques, complications invariably occur but they are uncommon. The risks are no greater for this procedure than are the risks for any other patient who undergoes ovary removal. If the patient has cancer, the oncologist should address any pre-operative medical needs.

Most cancers do not spread (metastasize) to the ovary. However, if cancer cells are in the ovarian tissue at the time of cryopreservation, they may survive freezing and thawing and they will be transplanted with the normal ovarian tissue. Transplantation of tumor containing ovaries resulted in cancer in the recipient animals. (36) You should ask your doctor for his/her opinion about the likelihood of metastatic cancer cells in the ovary.

Usually, pathology evaluates a sample of the excised ovary. However, the sample is insufficient to confirm a cancer-free ovary. In selected cases, researchers may be able to stain a small portion of the ovarian tissue for cancer markers that to detect tumor cells before transplanting the tissue strips. Other researchers explored the possibility of growing a sample of the ovarian tissue in an immune-deficient mouse to detect occult cancer in the tissue.

Most oncologists believe transmission of cancer cells should be very remote; however, the possibility is real and collaboration between the oncologist and the reproductive surgeon is essential to minimize this risk.

Currently, the process requires removal of all or a part of an ovary and less often both ovaries. The oophorectomy, by definition, will remove 50% of the woman's eggs. It follows that this should increase the probability of menopause from the chemotherapy or radiation to follow if one believes that menopause occurs earlier in women with fewer eggs. Available research suggests that complete removal of an ovary before age 30 accelerates the age of onset for menopause to 44 years, on average. Removing an ovary after age 30 has less effect, incrementally, on menopause.(37-39)

 

Future Directions

Any number of questions remain unanswered, but of critical importance, to bring this technique into mainstream use. For example: How long can the tissue remain frozen and still function after thawing?, Where is the best location to transplant the tissue strips?, How much ovarian tissue is required to provide enough eggs for successful pregnancy?, How long will the tissue function after transplantation?, and many more.

A very interesting avenue of research involves the growth of ovarian tissue from one species in another species (xenograft).(5;6;9;11;15;26) If this technique works and proves safe, several problems become less of an issue.

First, tissue grown in another animal prevents cancer in the human recipient. Even patients with ovarian cancers may be able to use this technique to recover normal eggs without any associated cancer cells. Second, the ovarian tissue contains a limited number of eggs. A xenograft may allow more efficient maturation and retrieval of eggs for IVF. Third, the limited tissue strips might be used more gradually over time for additional children.

Fourth, if only small amounts of tissue prove adequate for IVF, then a small biopsy of tissue in a young woman may be a means of banking eggs if she later finds herself infertile.

Another line of research is egg freezing. Ovarian stimulation similar to IVF allows egg retrieval. The eggs are frozen before they are inseminated and fertilized. Subsequently, when the time is right, the eggs are thawed and inseminated. Embryos derived from cryopreserved unfertilized eggs have yield embryos that developed into normal children. The number of children is limited but growing and the number of successful births clearly exceeds that with ovarian tissue cryopreservation. Only a few centers offer this technique.

 

Questions to ask your doctor and yourself before consulting a reproductive specialist.

Q: What is the likelihood that sterility will occur after treatment? Most patients view their participation in experimental therapies differently when the risk of sterility is 10% versus 90%.

Q: What is the risk of cancer cells in the ovary at the time of ovarian cryopreservation? Clearly, if the risk of metastatic cancer in the ovary is high, this technique is probably not a good idea until methods of extracting the eggs from the tissue without transplantation are available.

Q: How much time do you have before cancer therapy begins? With limited time (less than one month), IVF is impractical but surgery can be performed very quickly - within a few days if necessary. With more time, IVF for production of eggs or embryos is a realistic option.

Q: Are you single or married? Single women have less reason to pursue IVF and embryo cryopreservation unless they have a partner. Embryos formed with donor sperm may be less desirable for producing a family when later a woman finds a partner. Egg freezing may be a better option for single women. Women with a partner should consider IVF and freezing embryos. The woman may want to retain sole control of the embryos once they are frozen. Occasionally, marriages or relationships fail and the former partner could prevent the embryos from being used if the couple agrees to joint control of the embryos.

Q: Do you have a tumor sensitive to reproductive hormones? Women with breast cancer, for example, probably do not want to risk stimulation of their cancer from the high estrogen levels generated during IVF. Nevertheless, many breast cancer survivors can become pregnant safely, so some method of conserving their eggs seems reasonable.

Q: Are you willing to be part of a highly experimental research protocol? Until more experience is available, your participation in ovarian tissue cryopreservation places you on the cutting edge of science. Participation involves risks, known and unknown, and likely expenses that are not covered by insurance. If you are a healthy woman who wants to delay conception and pregnancy for any reason, the experimental and uncertain success of ovarian tissue cryopreservation makes this a very controversial technique for you. In addition to the experimental aspects of participation, the act of removing all or a portion of an ovary may actually increase the probability of an earlier menopause, which is counter-productive to the reason for participating.

Michael Opsahl, M.D. retired from a prestigious career in the United States Navy in 1994 and joined the Genetics & IVF Institute. Dr. Opsahl is board certified in Obstetrics and Gynecology and Reproductive Endocrinology.

 

Selected scientific articles:

1. Gosden RG, Baird DT, Wade JC, Webb R. Restoration of fertility to oophorectomized sheep by ovarian autografts stored at -196 degrees C. Hum Reprod 9[4], 597-603. 1994. 
2. Wang H, Mooney S, Wen Y, Behr B, Polan ML. Follicle development in grafted mouse ovaries after cryopreservation and subcutaneous transplantation. Am J Obstet Gynecol 187[2], 370-374. 2002. 
3. Salle B, Demirci B, Franck M, Rudigoz RC, Guerin JF, Lornage J. Normal pregnancies and live births after autograft of frozen-thawed hemi-ovaries into ewes. Fertil Steril 77[2], 403-408. 2002.
4. Schnorr J, Oehninger S, Toner J, Hsiu J, Lanzendorf S, Williams R, Hodgen G. Functional studies of subcutaneous ovarian transplants in non-human primates: steroidogenesis, endometrial development, ovulation, menstrual patterns and gamete morphology. Hum Reprod 17[3], 612-619. 2002.
5. Snow M, Cox SL, Jenkin G, Trounson A, Shaw J. Generation of live young from xenografted mouse ovaries [In Process Citation]. Science 2002 Sep 27;297[5590], 2227. 2002. 
6. Wolvekamp MC, Cleary ML, Cox SL, Shaw JM, Jenkin G, Trounson AO. Follicular development in cryopreserved Common Wombat ovarian tissue xenografted to Nude rats. Anim Reprod Sci 65[1-2], 135-147. 2001. 
7. Liu J, Van der EJ, Van den BR, Dhont M. Live offspring by in vitro fertilization of oocytes from cryopreserved primordial mouse follicles after sequential in vivo transplantation and in vitro maturation. Biol Reprod 64[1], 171-178. 2001. 
8. Kim SS, Battaglia DE, Soules MR. The future of human ovarian cryopreservation and transplantation: fertility and beyond. Fertil Steril 75[6], 1049-1056. 2001. 
9. Gook DA, McCully BA, Edgar DH, McBain JC. Development of antral follicles in human cryopreserved ovarian tissue following xenografting. Hum Reprod 2001 Mar;16[3], 417-422. 2001.
10. Callejo J, Salvador C, Miralles A, Vilaseca S, Lailla JM, Balasch J. Long-term ovarian function evaluation after autografting by implantation with fresh and frozen-thawed human ovarian tissue. J Clin Endocrinol Metab 86[9], 4489-4494. 2001. 
11. Metcalfe SS, Shaw JM, Gunn IM. Xenografting of canine ovarian tissue to ovariectomized severe combined immunodeficient (SCID) mice. J Reprod Fertil Suppl 2001;57, 323-329. 2001. 
12. Radford JA, Lieberman BA, Brison DR, Smith AR, Critchlow JD, Russell SA, Watson AJ, Clayton JA, Harris M, Gosden RG, Shalet SM. Orthotopic reimplantation of cryopreserved ovarian cortical strips after high-dose chemotherapy for Hodgkin's lymphoma. Lancet 357[9263], 1172-1175. 2001. 
13. Kagabu S, Umezu M. Transplantation of cryopreserved mouse, Chinese hamster, rabbit, Japanese monkey and rat ovaries into rat recipients. Exp Anim 49[1], 17-21. 2000. 
14. Cox S, Shaw J, Jenkin G. Follicular development in transplanted fetal and neonatal mouse ovaries is influenced by the gonadal status of the adult recipient. Fertil Steril 74[2], 366-371. 2000. 
15. Nisolle M, Casanas-Roux F, Qu J, Motta P, Donnez J. Histologic and ultrastructural evaluation of fresh and frozen-thawed human ovarian xenografts in nude mice. Fertil Steril 2000 Jul;74[1], 122-129. 2000. 
16. Oktay K, Newton H, Gosden RG. Transplantation of cryopreserved human ovarian tissue results in follicle growth initiation in SCID mice. Fertil Steril 73[3], 599-603. 2000.
17. Candy CJ, Wood MJ, Whittingham DG. Restoration of a normal reproductive lifespan after grafting of cryopreserved mouse ovaries. Hum Reprod 15[6], 1300-1304. 2000.
18. Imthurn B, Cox SL, Jenkin G, Trounson AO, Shaw JM. Gonadotrophin administration can benefit ovarian tissue grafted to the body wall: implications for human ovarian grafting. Mol Cell Endocrinol 163[1-2], 141-146. 2000. 
19. Shaw JM, Cox SL, Trounson AO, Jenkin G. Evaluation of the long-term function of cryopreserved ovarian grafts in the mouse, implications for human applications. Mol Cell Endocrinol 161[1-2], 103-110. 2000. 
20. Weissman A, Gotlieb L, Colgan T, Jurisicova A, Greenblatt EM, Casper RF. Preliminary experience with subcutaneous human ovarian cortex transplantation in the NOD-SCID mouse. Biol Reprod 60[6], 1462-1467. 1999. 
21. Baird DT, Webb R, Campbell BK, Harkness LM, Gosden RG. Long-term ovarian function in sheep after ovariectomy and transplantation of autografts stored at -196 C. Endocrinology 140[1], 462-471. 1999. 
22. Callejo J, Jauregui MT, Valls C, Fernandez ME, Cabre S, Lailla JM. Heterotopic ovarian transplantation without vascular pedicle in syngeneic Lewis rats: six-month control of estradiol and follicle-stimulating hormone concentrations after intraperitoneal and subcutaneous implants. Fertil Steril 72[3], 513-517. 1999. 
23. Meirow D, Fasouliotis SJ, Nugent D, Schenker JG, Gosden RG, Rutherford AJ. A laparoscopic technique for obtaining ovarian cortical biopsy specimens for fertility conservation in patients with cancer. Fertil Steril 71[5], 948-951. 1999. 
24. Salle B, Lornage J, Demirci B, Vaudoyer F, Poirel MT, Franck M, Rudigoz RC, Guerin JF. Restoration of ovarian steroid secretion and histologic assessment after freezing, thawing, and autograft of a hemi-ovary in sheep. Fertil Steril 72[2], 366-370. 1999. 
25. Aubard Y, Piver P, Cogni Y, Fermeaux V, Poulin N, Driancourt MA. Orthotopic and heterotopic autografts of frozen-thawed ovarian cortex in sheep. Hum Reprod 1999 Aug;14[8], 2149-2154. 1999. 
26. Gunasena KT, Lakey JR, Villines PM, Bush M, Raath C, Critser ES, McGann LE, Critser JK. Antral follicles develop in xenografted cryopreserved African elephant (Loxodonta africana) ovarian tissue. Anim Reprod Sci 53[1-4], 265-275. 1998. 
27. Sztein J, Sweet H, Farley J, Mobraaten L. Cryopreservation and orthotopic transplantation of mouse ovaries: new approach in gamete banking. Biol Reprod 58[4], 1071-1074. 1998.
28. Oktay K, Newton H, Mullan J, Gosden RG. Development of human primordial follicles to antral stages in SCID/hpg mice stimulated with follicle stimulating hormone. Hum Reprod 13[5], 1133-1138. 1998. 
29. Gunasena KT, Lakey JR, Villines PM, Critser ES, Critser JK. Allogeneic and xenogeneic transplantation of cryopreserved ovarian tissue to athymic mice. Biol Reprod 57[2], 226-231. 1997. 
30. Opsahl MS, Fugger EF, Sherins RJ, Schulman JD. Preservation of reproductive function before therapy for cancer: new options involving sperm and ovary cryopreservation. Cancer J Sci Am 3[4], 189-191. 1997. 
31. Marconi G, Quintana R, Rueda-Leverone NG, Vighi S. Accidental ovarian autograft after a laparoscopic surgery: case report. Fertil Steril 68[2], 364-366. 1997. 
32. Oktay K, Nugent D, Newton H, Salha O, Chatterjee P, Gosden RG. Isolation and characterization of primordial follicles from fresh and cryopreserved human ovarian tissue. Fertil Steril 67[3], 481-486. 1997. 
33. Gunasena KT, Villines PM, Critser ES, Critser JK. Live births after autologous transplant of cryopreserved mouse ovaries. Hum Reprod 1997 Jan;12[1], 101-106. 1997. 
34. Nugent D, Meirow D, Brook PF, Aubard Y, Gosden RG. Transplantation in reproductive medicine: previous experience, present knowledge and future prospects. Hum Reprod Update 3[3], 267-280. 1997. 
35. Newton H, Aubard Y, Rutherford A, Sharma V, Gosden R. Low temperature storage and grafting of human ovarian tissue. Hum Reprod 11[7], 1487-1491. 1996. 
36. Shaw JM, Bowles J, Koopman P, Wood EC, Trounson AO. Fresh and cryopreserved ovarian tissue samples from donors with lymphoma transmit the cancer to graft recipients. Hum Reprod 11[8], 1668-1673. 1996. 
37. Melica F, Chiodi S, Cristoforoni PM, Ravera GB. Reductive surgery and ovarian function in the human--can reductive ovarian surgery in reproductive age negatively influence fertility and age at onset of menopause? Int J Fertil Menopausal Stud 40[2], 79-85. 1995. 
38. Gosden RG, Faddy MJ. Ovarian aging, follicular depletion, and steroidogenesis. Exp Gerontol 29[3-4], 265-274. 1994. 
39. Faddy MJ, Gosden RG, Gougeon A, Richardson SJ, Nelson JF. Accelerated disappearance of ovarian follicles in mid-life: implications for forecasting menopause. Hum Reprod 7[10], 1342-1346. 1992. 

 

 

 

Pages