As there has recently been extensive media coverage of an ongoing child custody case resulting from a mix-up of embryos transferred by another Bay area IVF Center, we want to convey to our readers just how serious we consider this matter. Recognizing the devastating consequences of such an embryo mistake, many years ago we developed and put in place a system of patient-embryo recognition we call Pacific Fertility Center’s SurTransfer^SM protocol. To help dispel any unwarranted fears surrounding your IVF cycle, we are presenting in this issue a detailed explanation of this important system of multiple checkpoints and special procedures for ensuring proper recognition of all reproductive materials.

All of us who work in the field of assisted reproduction recognize the potential for human error. We feel very fortunate at Pacific Fertility Center to have never had a known case of mistaken identity and gamete or embryo mix-up in our In Vitro Fertilization program. However, we continually look for new and better ways to ensure these errors never will occur. Please know if ever there should be any mishaps with eggs, sperm or embryos, we are committed to immediate, complete and total forthrightness and honesty with our patients.

We find it reassuring there have been over 100,000 babies born in the U.S. with the help of IVF since the first birth in 1979 and instances of embryo or gamete mix-up are extremely rare. At Pacific Fertility Center we plan to maintain our positive track record through the continued use of our proven SurTransfer^SM protocol. Our fertility team strongly believes that, along with providing safe and successful infertility care, maintaining correct laboratory procedures is an equally important responsibility.

Sincerely,
Joe Conaghan, PhD, Philip Chenette, MD, Carolyn Givens, MD,
Carl Herbert, MD, Isabelle Ryan, MD, Eldon Schriock, MD

Q. How can I be sure that PFC will not accidentally confuse my eggs and my husband’s sperm and our embryos with someone else’s?

A. PFC recognizes that even with the best intentions, human error can occur. We’ve therefore designed our strict SurTransfer^SM laboratory security system of color-coding and clearly labeling all specimens and verbally identifying all patients. We have also devoted considerable time and effort into assembling one of the most highly trained teams in the country. Each of our Embryologists is Board Certified and Licensed, even though the State of California does not currently require licensure for Embryologists.
When a patient is scheduled for a procedure, a written procedure requisition is sent by the Physician to the laboratory staff, giving them at least 24hour notice and clear instructions on what is to be done. Each patient is assigned a specific color for their test tubes and Petri dishes; no two patients having procedures on the same day will be assigned the same color. Each of the patient’s specimens is carefully labeled with clear and unique identifying information that includes the patient’s name and date of birth.

During their stay in the lab, eggs, sperm and embryos are kept in incubators. We avoid assigning two cases to a single incubator on the same day. Each incubator has an exterior door and an interior door. Both doors are clearly labeled with name and color code. This labeling protocol allows the embryologist to verify the name twice before ever handling the specimen.

We have two embryologists performing all critical procedures to ensure accuracy; generally one handles the material while the other observes and verifies. We are not required to assign two people to procedures, but redundancy eliminates the possibility of an error.

Both embryologists sign off after checking the paperwork, labeling the specimen and performing the procedure.
Accepting sperm samples: When a man delivers his sample, we require it to be labeled with his unique information, including name, birth date and signature. We ask to see identification. The embryologist receiving the sample will sign that s/he received it and note the time and date of receipt. If s/he passes the sample to another member of staff, that individual will sign for it, thus continuing a chain of responsible custody.

Egg retrieval: A patient undergoing egg retrieval is asked in the retrieval room to identify herself before receiving sedating drugs. The embryologist will not rely on the physician, nor state the patient’s name and ask for a “yes or no” answer, but will instead ask her to state her full name. This avoids any possible miscommunication. As the procedure gets underway, two embryologists will take responsibility for accepting the collected eggs.

Inseminating eggs: This is arguably the most important part of the IVF procedure. While it is a relatively simple procedure to perform, we are sensitive to its significance. Without any exceptions, two embryologists perform the insemination. Even if there is only one egg to inseminate, or even if there is only one insemination on a given day, two people do it.

Embryo transfer: Similar to the retrieval procedure, one embryologist will ask the patient her name and a second embryologist will witness and verify that the correct embryos are loaded into the transfer catheter. As a final check, the embryologist will hand the catheter to the physician and state the patient’s full name and the number of embryos.

Freezing and thawing of sperm or embryos:

Frozen specimens are extensively labeled and catalogued. Thawing can only be directed by a physician, and as a rule an embryologist never handles or thaws a specimen without a witness. Once a specimen is thawed, there’s no going back.

Law Tries to Keep Up with ART: A spate of judicial decisions here in California has family law attorneys paying close attention to a handful of unique conflicts, or “gray zones” made in some way possible by Assisted Reproductive Technologies (ART). As the definition of “family” expands more broadly, thanks to ART, new laws are actually being forged. Couples that don’t fit the rubric of a traditional family (heterosexual man + woman = marriage) are being asked to make sure they have all of their legal ducks in a row.

A few California cases are summarized here, including at least one that may reach the state Supreme Court.

Lesbian Parents and Child Support: This complex case involves two lesbian partners, not registered as domestic partners, who jointly agreed to have children using the same sperm donor. Both women conceived, one year apart, and one of the infants was born with Down syndrome, prompting one of the women to remain at home as the care-giver. Two years later, the two women separated and the primary caregiver began receiving monthly child support payments from the woman who worked. When the child support provider halted payments after 18 months, county social workers attempted to tap her wages, a standard to which a biological father would have been held.

Although a Superior court judge agreed with the county that child support payments should continue because the woman showed initial “intent” to raise the children, this past May the Court of Appeal in Sacramento reversed that decision to the dismay of gay rights legal activists. This decision is particularly disturbing, asserts Deborah Wald, a San Francisco attorney who specializes in non-traditional family law. “Children of same-sex couples do not have the same rights compared to children that have two parents of opposite sex; this is a shocking ruling and one that we are confident that the state Supreme Court will overturn,” she said. Posthumous Conception: Many are anxiously watching a case that is pending final decision by the Los Angeles federal court. A wife had medical personnel extract her husband’s sperm for freezing after his unexpected death. This was not contested. Four years later, after she conceived a daughter with his sperm, the mother sought Social Security survivor benefits. Although she didn’t seek inheritance or life insurance claims, the outcome of this case is expected to have implications in these other areas.

The Social Security Administration denied the benefits, insisting that the deceased dad is not recognized as the father under California law. The SSA follows specific state guidelines in resolving such issues, and has granted posthumous benefits in other states. But California has no laws governing children conceived after the death of a parent. This case has simultaneously prompted the state Legislature to craft AB 1910, which is enjoying broad support. This bill establishes that a posthumously conceived child is entitled to inheritance rights and other benefits under the Uniform Parentage Act if the decedent intended his or her genetic material to be used for posthumous conception of the child and expressed it in writing. It is expected to be signed by the Governor in September. Copies can be found at www.assembly.ca.gov .

Lesbian Parents and Custody: A woman who provided the donor eggs for her female partner, enabling the partner to conceive twins, signed away her parental rights per a standard egg donor contract used by a Bay Area infertility clinic seven years ago. Nevertheless, the two women spent the next six years living together and raising the children. As the egg donor started pressuring the gestational mother about being identified as a legal co-parent, their relationship fell apart, and the gestational mother moved across country with the twins, eventually cutting off all contact between the children and the egg donor.

A California Court of Appeals ruling affirmed the gestational mother’s hold on primary custody, saying its decision is based on the “intent” contract signed by the egg donor, which absolved her of all parental rights and future claims. The biological mother has appealed, the case has received a flurry of press, and the case may end up at the First District Court of Appeal in 2005.

Q. Considering how much trouble we’re going through to get pregnant, I don’t mind if we have twins, or even triplets. What do you think?

A. Many parents undergoing infertility treatment are open to, or even welcome the idea of having more than one baby without fully understanding the risks that a multiple gestation pregnancy poses to the mother and infants. You are wise to research this thoroughly before entering into your cycle.
Let’s first look at the facts:
– Over 50% of twin pregnancies result in preterm births;
– Over 90% of triplet pregnancies result in preterm births;
– Virtually all pregnancies of quadruplets (and greater) result in premature labor;
– Compared to a singleton pregnancy, a twin is seven times more likely, and a triplet is
over 20 times more likely to die in the first month of life.

Even with medical advances to handle early birth trauma, premies are more likely to suffer from respiratory distress syndrome, intra-cranial hemorrhage, cerebral palsy, blindness and neonatal morbidity. These stark statistics and more have been compiled by the American Society for Reproductive Medicine (www.asrm.org), and distributed in a patient’s fact sheet.

Because these facts are undisputed, infertility specialists with the help of our professional associations began a campaign to actively educate couples about the risks of multiple gestations, and to make responsible decisions. Fortunately, this work is now showing results. Research published in the April 14th 2004 New England Journal of Medicine revealed a drop since 1997 in the number of high-order multiple pregnancies. In 1997, women under 35 faced nearly a 14 percent chance of having triplets or more! Today that figure has dropped to 8.1 percent, which is still higher than the natural incidence of multiple gestation.

Couples who share the goal of conceiving a single, healthy child generally end up as happy, and with far fewer complications, as those couples that have more. If the embryos are of good quality, our doctors will transfer no more than two embryos in a first IVF cycle for women under 35. Bear in mind that identical twins are possible, since an embryo can split in two. If a couple is opposed to selective reduction, a single embryo transfer is sometimes the best choice, especially if a young donor’s eggs are used.

With our guidance and your understanding, we trust you will make the right decision for your health and the health of your baby.

Did you know that 343 babies were born as a result of assisted reproduction procedures performed at Pacific Fertility Center in 2002? Of these 343 babies, 98 or 28.6%, were babies conceived after having been stored as a frozen embryo.

This year marks the 20th anniversary of the first successful birth that resulted from human embryo cryopreservation. Since then, thousands of babies have been born worldwide after having undergone embryo cryopreservation. Freezing of excess good quality embryos allows for the transfer of fewer embryos in the stimulated IVF cycle and therefore ensures fewer high-order (triplets or more) multiple births. This process provides patients with a “back-up” should the initial fresh embryo transfer not result in a pregnancy. It is a much lower cost procedure than starting IVF all over again and often is performed with minimal medications. Frozen embryo transfers (FET) have allowed many of our patients to achieve more than one pregnancy from a single cycle of ovarian stimulation.

How safe is embryo cryopreservation? Even after 20 years, there are few studies in the scientific and medical literature concerning outcomes after embryo cryopreservation. However, the few studies that have been published are thus far reassuring.

The four largest studies performed on children conceived after embryo freezing have been done in England, France, Greece and Sweden. In all of these, the authors reported no significant difference in minor or major malformation rates in babies compared to fresh IVF embryo transfers or spontaneously conceived babies. The largest was the Swedish study, which followed 255 children born after embryo cryopreservation up to 18 months of age. Researchers compared them to 255 children born stimulated IVF cycle and therefore ensures fewer high-order (triplets or more) multiple births. This process provides patients with a “back-up” should the initial fresh embryo transfer not result in a pregnancy. It is a much lower cost procedure than starting IVF all over again and often is performed with minimal medications. Frozen embryo transfers (FET) have allowed many of our patients to achieve more than one pregnancy from a single cycle of ovarian stimulation.

How safe is embryo cryopreservation? Even after 20 years, there are few studies in the scientific and medical literature concerning outcomes after embryo cryopreservation. However, the few studies that have been published are thus far reassuring. The four largest studies performed on children conceived after embryo freezing have been done in England, France, Greece and Sweden. In all of these, the authors reported no significant difference in minor or major mal-formation rates in babies compared to fresh IVF embryo transfers or spontaneously conceived babies. The largest was the Swedish study, which followed 255 children born after embryo cryopreservation up to 18 months of age. Researchers compared them to 255 children born. The longest-term follow-up was conducted in the French study, which followed 82 children, aged 1-9, born after cryopreservation as embryos. The total malformation rate was 3.4%. Incidence of medical and surgical illness was not excessive and scholastic performance in the older children was as expected.

What is the longest time an embryo can remain frozen and still be viable? Just this month, a clinic in Israel reported the birth of healthy twins from a transfer of frozen-thawed embryos that had been cryopreserved for 12 years. Embryos, once frozen, may have unlimited potential for viability, as long as they remain at the extremely low temperatures of liquid nitrogen storage.

At Pacific Fertility Center, we are very proud of our record of success with frozen embryo transfers. We see many healthy children at baby visits that were once stored at PFC as frozen embryos. We believe that the data on safety is reassuring. We see cryopreservation as yet another way for patients to achieve healthy pregnancies through assisted reproduction.

References:

Postnatal growth and health in children born after cryopreservation as embryos. Wennerholm UB, Albertsson-Wikland K, Bergh C, Hamberger L, Niklasson A, Nilsson L, Thiringer K, Wennergren M, Wikland M, Borres MP. Lancet. 1998 Apr 11;351(9109):1085-90.

Perinatal outcome and follow-up of 82 children aged 1-9 years old conceived from cryopreserved embryos. Olivennes F, Schneider Z, Remy V, Blanchet V, Kerbrat V, Fanchin R, Hazout A, Glissant M, Fernandez H, Dehan M, Frydman R. Hum Reprod. 1996 Jul;11(7):1565-8.

Minor congenital anomalies, major congenital malformations and development in children conceived from cryopreserved embryos. Sutcliffe AG, D’Souza SW, Cadman J, Richards B, McKinlay IA, Lieberman B. Hum Reprod. 1995 Dec;10(12):3332-7.

Follow-up of children conceived from cryopreserved embryos. Sutcliffe AG. Mol Cell Endocrinol. 2000 Nov 27;169(1-2):91-3.

Outcome in children from cryopreserved embryos. Sutcliffe AG, D’Souza SW, Cadman J, Richards B, McKinlay IA, Lieberman B. St Mary’s Hospital, Manchester. Arch Dis Child. 1995 Apr;72(4):290-3.

Pregnancy and child outcome after assisted reproduction techniques. Tarlatzis BC, Grimbizis G. Hum Reprod. 1999 Sep;14 Suppl 1:231-42.

Twin delivery following 12 years of human embryo cryopreservation: case report. Revel A, Safran A, Laufer N, Lewin A, Reubinov BE, Simon A. Hum Reprod. 2004 Feb;19(2):328-9.