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OVARIAN CRYOPRESERVATION AND TRANSPLANTATION: An Emerging Tool for Fertility Preservation By Kutluk Oktay, M.D.

In the US alone, hundreds of thousands of women and children are subjected to medical treatment which result in infertility and premature ovarian failure. Among the many treatments that cause infertility and premature ovarian failure are:

1) Chemotherapy: Women and children are given chemotherapy for not only cancer but other conditions such as treatment of lupus nephritis, rheumatoid arthritis, sickle cell anemia etc. A common chemotherapy agent cyclophosphamide causes significant damage to ovarian follicles and result in infertility.

2) Radiation treatment: Pelvic and whole body radiation is also used in the treatment of thousands of cancer and non-cancer patients and when ovaries are in the vicinity of the radiation area, fertility is compromised

3) Tens of thousands of women undergo ovary removal procedures for benign diseases such as endometriosis and ovarian cysts.

4) Thousands of women undergo ovary removal preventively when there is family history of ovarian cancer and/or when BRCA gene is detected.

 

What are the techniques to preserve fertility?

When there is enough time and no medical hurdle to perform ovarian stimulation, and if the patient has a partner, embryo freezing can be performed to preserve fertility. In single patients, even though the success rates are much lower than that of embryo freezing, oocyte freezing is also possible. Even in breast cancer patients, tamoxifen or letrozole (an aromatase inhibitor) can be used to stimulate ovaries for the purpose of embryo or oocyte freezing. Unfortunately children, and many adult patients who have to start their sterilizing treatments within a short time will not have sufficient time to undergo ovarian stimulation. Ovarian tissue freezing was developed for those patients who cannot utilize more established assisted reproduction techniques to preserve fertility.

 

How is ovarian tissue frozen?

This procedure does not require ovarian stimulation and can be done anytime during the cycle. Typically, one ovary is removed with a simple laparoscopic technique within an hour, and the patient is discharged home the same day. The mantle of the ovary, which contains all the immature eggs called primordial follicles is separated from the connective tissue of the ovary and cut into dime size pieces. These pieces were then mixed with antifreeze substances and then frozen with a computerized machine very slowly. Tissue pieces are then stored in liquid nitrogen as long as needed without any significant compromise.

 

How is ovarian tissue transplanted?

Ovarian tissue can be transplanted either back to its origin in patient’s pelvis or it can be placed underneath the patient’s skin either in the forearm or lower abdomen. The latter technique is developed because:

1) In some cancer patients it may not be completely safe to put back ovarian tissue inside the body; It can be done under local anesthesia with less inconvenience , discomfort, and cost to the patient

2) Tissue can be tracked more practically

3) Not all of the tissue pieces are needed to implanted at once; since this is a procedure with local anesthesia, tissue strips can be inserted in repetitive procedures as the prior ones run out of its egg reserve.

Both techniques resulted in reversal of menopause in several patients. However, up until now only with placement under the skin that in vitro fertilization and embryo development was possible. Quest for achieving the first pregnancy after ovarian transplant is continuing in several centers around the world.

 

Are there any risks associated with ovarian transplant?

The biggest theoretical risk is the possibility of the transplanted ovarian tissue harboring cancer cells. For most cancers of children and young women however, this risk is negligible. In all cases of ovarian transplant however, samples of tissue are tested for presence of cancer cells prior to transplant. Because ovarian transplantation is a very recent experimental technique, a record of long term success and safety has not yet been established in patients. However, animal studies showed successful pregnancies without an increase in birth defects.

 

Conclusions:

Ovarian cryopreservation and transplantation are currently used to preserve fertility in women who run the risk of infertility and premature ovarian failure due to medical treatments. Even though pregnancies occurred in animal studies and embryos developed in patients after ovarian transplantation, first pregnancies are anticipated in patients within the recent future. At the present time, this experimental technique is recommended for elective purposes, such as postponement of childbearing.

 

References

Oktay K, Buyuk E, Veeck L et al. Embryo development after heterotopic transplantation of cryopreserved ovarian tissue. Lancet. 2004 Mar 13;363 (9412): 837-40.

Sonmezer M and Oktay K. Fertility preservation in female patients.
Hum Reprod Update. 2004 May-Jun;10(3):251-66.

Oktay K and Buyuk E. Fertility preservation in women undergoing cancer treatment.
Lancet. 2004 May 29;363(9423):1830. Oktay et al, JAMA

Oktay K and Karlikaya G. Ovarian function after transplantation of frozen, banked autologous ovarian tissue.
N Engl J Med. 2000 Jun 22;342(25):1919.

Oktay K, Buyuk E, Davis O et al. Fertility preservation in breast cancer patients: IVF and embryo cryopreservation after ovarian stimulation with tamoxifen.
Hum Reprod. 2003 Jan;18(1):90-5.

Kutluk Oktay, M.D. 
Phone: 212-746-1762
Email: kuo9001@med.cornell.edu
 

 

Fertility Preservation: Egg Freezing by Geoffrey Sher, MD

Egg Freezing
By Geoffrey Sher, MD

 

Women who want to preserve their fertility for reasons of cancer treatment, career, or other personal choice, have faced a difficult barrier due to the poor success rates for egg freezing.  Pregnancy rates for women using frozen/thawed eggs have been less than 4% for each individual egg frozen.  This is due to the fact that;  1) at least 60% of eggs frozen are chromosomally abnormal from the outset and therefore cannot produce a normal embryo and; 2) traditional (slow) egg freezing techniques commonly cause ice crystal formation within the cell structure, reducing viability or destroying the cells in the process.

 

A recent published breakthrough by SIRM and its affiliate, ReproCure (Genetics), addresses both of these issues, markedly reducing the downside of egg/embryo freezing.  It involves CGH, the method described above for identifying all the chromosomes in the cell .

 

First, using proprietary CGH process-technology, eggs are tested for their chromosomal integrity prior to freezing, ensuring that only the "competent" ones  are frozen.  Second, a new method of ultra-rapid freezing (recently modified by ReproCure) called "vitrification" is used, allowing much more successful freezing without ice crystal formation.  Through this CGH/Vitrification combination, we have been able to achieve post-thaw pregnancy rates that are more than 8 times higher per egg stored than previously reported methods.

 

At SIRM/ReproCure we have transferred embryos derived from CGH-tested eggs and embryos to more than 300 women resulting in >100 births and as many pregnancies still ongoing, thereby accounting for more CGH-derived pregnancies than the rest of the ART world combined. We are convinced that use of this technology will progressively grow and within the next 5-10 years will a "new standard of care" in the ART arena.

 

This exciting breakthrough, published recently in the medical journal "Reproductive Biomedicine Online" has opened the door to viable fertility preservation (FP) for women. We are now offering egg freezing and banking services at SIRM offices nationwide.

 

 

For more information visit http://www.haveababy.com
Dr. Saleh of Dallas also will answer your questions on INCIID Forums. http://www.inciid.org/forum/

 

For more information visit http://www.haveababy.com
Dr. Saleh of Dallas also will answer your questions on INCIID Forums. http://www.inciid.org/forum/

 

 

Cancer & Fertility: What you need to know BEFORE you begin your Cancer Treatment.

In this section:

 

OVARIAN CRYOPRESERVATION AND TRANSPLANTATION: An Emerging Tool for Fertility Preservation By Kutluk Oktay, M.D.
In the US alone, hundreds of thousands of women and children are subjected to medical treatment (including treatment for cancer). These treatments can result in infertility and premature ovarian failure. What can be done to help perserve fertility? Dr. Kutluk Oktay, gives an overview.

Ovarian Cryopreservation by Michael Opsahl, MD
There are a number of medical treatments (including chemotherapy) and other cancer treatments that can destroy the ability to procreate. Read about ovarian cryopreservation - a hope for the future

 

Surrogacy in the Metropolitan Washington, DC Area by Diane S. Hinson and Linda C. ReVeal

Surrogacy in the Metropolitan Washington, DC Area
Maryland, the District of Columbia, and Virginia 
by Diane S. Hinson and Linda C. ReVeal

 

Every day, people who live in the Washington, DC metropolitan area drive through the adjacent jurisdictions of Maryland, the District of Columbia, and Virigina without giving much notice as they pass from one jurisdiction into another.  Surrogates, however, do not have that luxury.  In fact, they are required to take notice.  Surrogacy contracts typically put restrictions on a surrogate’s travel outside her state of residence after a certain number of weeks --  and the surrogacy laws of Maryland, DC and Virginia vary so dramatically that a surrogate living in Maryland will often be prohibited in her contract from traveling into nearby DC or Virginia in the late stages of her pregnancy!

In a nutshell:  The District of Columbia has a statute that makes all surrogacy contracts illegal – indeed, criminal.  Virginia has a statute that permits surrogacy, but restricts it to those who fit within narrow and conservative limitations, making the option of surrogacy off-limits to many prospective parents.  Maryland, by contrast, has no statute but has developed case law that is favorable to gestational surrogacy, even those creating non-traditional families.  Traditional surrogacy, however, is questionable in Maryland and most likely illegal. 

We will examine each jurisdiction in turn. We start with Maryland, which offers the  best protections for the majority of Gestational Carriers and Intended Parents and, indeed, is currently one of the most popular states for Gestational Carrier Surrogacy.

 

Maryland: Good for Gestational Surrogacy and Open to Same-Sex Families. Traditional Surrogacy Likely Illegal

Intended parents of all types come to Maryland from all over the United States and abroad to work with Gestational Carriers.   Maryland is considered a “surrogacy-friendly” state because the laws permit intended parents to establish their parental rights in Maryland courts.  Many parents are able to obtain a pre-birth parentage order, declaring the intended parents to be the sole legal parents and terminating any presumed parental rights of the Gestational Carrier.  A birth certificate may then be obtained in the first instance that includes only the names of the intended parents.  Intended Parents are well advised to procure the services of an experienced Assisted Reproductive Technology attorney in Maryland to ensure that the case is adjudicated in a county that will issue a pre-birth order --,particularly if the intended parents are a same-sex couple, a single parent, an unmarried couple, or a couple using donor gametes. 

There is no statute in Maryland that governs surrogacy and only one published judicial opinion:  In Roberto de.B., 372 Md. 684, 814 A.2d 570 (2003), Maryland’s Court of Appeals (the highest court in Maryland) held that a Gestational Carrier who carried twins for a single father should not be listed as the mother on the birth certificate because she was not the genetic mother, but rather a Gestational Carrier.  That ruling gave the official judicial stamp of approval to gestational surrogacy in Maryland. 

Traditional surrogacy, however, is a different story.  Available precedent in Maryland strongly indicates that traditional surrogacy runs afoul of Maryland’s very strict anti-baby selling law.  In Maryland, a birth mother cannot receive any fees or reimbursements in connection with an adoption for any costs other than medical or legal expenses.  In  2000, Maryland’s Attorney General isued an opinion in which he concluded that paid traditional surrogacy violates the baby-selling statute because a traditional surrogate is giving up parental rights to her own child.  She is essentially “a birth mother” and, therefore, must be treated like one for compensation purposes.  Notably, the Attorney General distinguished Gestational Surrogacy as factually different (given that a Gesational Carrier is not genetically related to the child).

Today, virtually all surrogacy cases in Maryland in which attorneys are involved are Gestational Surrogacy cases.  The family law courts continue to recognize the intended parents working with Gestational Carriers as the sole legal parents, consistent with the holding of Roberto d.B.  And, depending on the particular court, pre-birth orders granting parental rights have been issued to “traditional” married couples, single parents, unmarried heterosexual couples, couples using donor gametes, and same-sex couples..

As with any state in which there is no statute, there is always the risk that new legislation might change the equilibrium.  Over the years, legislation pertaining to surrogacy has been proposed numerous times in Maryland and at least two separate bills have been vetoed by the sitting governor.  More recently, legislation has been proposed that would establish a commission to evaluate the need for surrogacy legislation.  Although this legislation has failed to make it out of committee, interest in some sort of regulatory oversight nevertheless continues.

 

DC: Surrogacy Contracts are Criminal

Surrogacy contracts are prohibited by statute in Washington, DC.  In fact, entering into a surrogacy agreement in Washington, DC is a criminal offense, punishable  by a fine up to $10,000 and up to a year in prison.  This prohibition, which appears to apply to any kind of surrogacy contract, dates back to the early 1980’s, when only traditional surrogacy existed.  The first gestational surrogacy birth did not occur until 1985.  The statute, however, has never been amended to differentiate between the two kinds of surrogacy.

 

VA: Surrogacy is Permitted but with Strict Limitations that

Restrict its Scope Significantly
Virginia is one of a handful of states with extensive legislation governing surrogacy.  In fact, it was the intention of the Virginia legislature to provide a haven for both traditional and gestational surrogacy, crafting legal protections for all involved.  Ironically, the result of these good intentions was a set of very restrictive and conservative limitations that makes surrogacy in Virginia unattainable for many families and arduous or risky for those who do qualify.

First, the statute limits surrogacy to married couples between a man and a woman,  and the wife must be able to demonstrate infertility.  Same-sex families need not apply.  Indeed, gay couples are not even allowed to adopt in Virginia – a restriction that extends to second parent adoptions after deliveries by surrogacy. 

Second, for families that do qualify, Virginia imposes a panoply of additional restrictions:  A third party “broker” cannot be paid to assist in matching the intended parents and the surrogate.  Compensation to the Surrogate is strictly limited to “reasonable medical and ancillary costs.”   And the parents cannot formally establish their legal parental rights until at least three days after the child is born, when they file the “Surrogate Consent and Report Form” that must be signed by all parties, including the Gestational Carrier.  If she declines to sign the form, then even though she is in breach of her contract, and even though one or both of the Intended Parents are likely the genetic parents of the child, she nonetheless is still legally the Child’s parent under the VA statute. 

On the plus side, Virginia surrogacy agreements can be pre-approved by the court, giving them the force of law right from the outset.  That option appears to be more of a theoretical than a practical option, however.   The process to have a surrogacy agreement pre-approved is time consuming and expensive, requiring both an extensive home study to be done, much like in in an adoption proceeding, and further that a guardian ad litum be appointed to represent the unborn child.   As a result, very few people choose to go through such a procedure.  By the time most couples decide to undertake a surrogacy journey, they would like it to have happened “yesterday.”  They do not want it to take an additional 10-12 months.

Accordingly, most intended parents who proceed with a surrogate in VA do so without obtaining prior court approval.  In addition, many intended parents do surrogacy through self-matching and with a relative or friend so that it is a compassionate surrogacy, eliminating the compensation and their worry that the surrogate might change her mind. 

It is also sometimes possible that even with a Virginia surrogate, the case can still be governed under MD law.  If a GC match looks good, the first thing we determine is where everyone lives.  If the GC lives in VA and the IPs live in MD, and the GC is willing to regularly goes to an obstetrician who practices in MD and has delivery privileges in MD, that establishes enough of a nexus (or connection) that she has demonstrated her intent to deliver in MD.  The MD delivery, in turn, establishes a nexus to the State of MD sufficient for the surrogacy contract to be written under MD law and for the petition for parentage to be filed in a Maryland court!  In the law, this is called “choice of law.”  In the Metropolitan DC area, the choice is clear:  The choice is Maryland.*

 

*The information in this article is not, nor is it intended to be, legal advice. You should consult an attorney for individual advice regarding your own situation

 

Email:
Diane S. Hinson, Esq.**
Linda C. ReVeal, Esq.

 

Visit:
Creative Family Connections LLC
2 Wisconsin Circle
Suite 700
Chevy Chase, MD 20815
240-235-6006 phone
240-235-4555 fax

**Fellow, American Academy of Assisted Reproduction Technology Attorneys
Member, American Bar Association, Committee on Assisted Reproductive Technologies
Member, Legal Professional Group, American Society of Reproductive Medicine

 

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