Multiple Births with Fertility Drugs

As a Fertility Physician, one of the most frequently asked questions, and one of the largest concerns expressed by Fertility Patients regards the risk of multiple births. This concern has been exacerbated by the recent publicity associated with the birth of octuplets in California.

Why do fertility physicians not want to have pregnancies that result in multiple births?

Multiple births including twins can be associated with prematurity and other complications that jeopardize the health of the baby or babies. The higher the number of multiples, the higher the risk there is of prematurity and all of its associated complications. The bad outcomes associated with multiple births are associated with both immediate and long term problems. Immediate problems can include difficulties with breathing associated with poorly developed lung function. This often jeopardizes the immediate survival of these infants. Longer term problems may include poor development of the baby with possible long term physical and learning disabilities.

Fertility physicians are constantly walking the thin line between assisting the couple to achieve a pregnancy, but more importantly to ensure that the pregnancy produces a healthy infant that will live and develop a normal life. Unfortunately, in many cases, more aggressive treatment will lead to a higher pregnancy rate, but the downside of more aggressive therapy is the possibility of high order multiple pregnancies with all of their negative outcomes. Unfortunately, the Fertility Industry in the United States is a highly competitive field, with many of the treatments not covered by Insurance. Overheads associated with high tech fertility clinics are high, and clinics can be motivated by financial factors to "push the envelope" of therapy to ensure high rates of success. It is very important that the philosophy of the particular clinic encompasses the larger picture of not only producing a pregnancy, but producing a healthy baby by not compromising the health of either the mother or child.

Until recently, the Fertility Industry in the United States has been largely unregulated. ART clinics are now mostly reporting their results to the CDC in Atlanta Georgia. The CDC in conjunction with the Society for Assisted Reproductive Technologies has made major efforts to standardize the success rates of various clinics, so that consumers are able to make an "apple to apple" comparison of the outcomes of various clinics. In spite of these efforts, other variables that are not reportable may come into play in regard to measuring the outcomes of various clinics. An example may be that Clinic A is not willing to fertilize a small select number of eggs in Roman Catholic patients or other religious persuasions that may not want to deal with the ethical and moral issues of multiple embryos. Clinic A may want to be able to report higher success rates to drive further business and may not allow patients this therapeutic option. Clinic B, on the other hand may offer this type of therapy, knowing full and well that this may not lead to optimal embryo selection. With proper counseling, there are patients who may opt for the second option, knowing full and well that they may be compromising their chances of success.

What are some of the risks of multiples associated with various fertility treatments?

  • Clomiphene citrate (Clomid, Serophene) is the only FDA approved oral drug for ovulation induction. The generally accepted twin rate in patients using this medication is 10%.
  • Letrezole or Femara, which is frequently used for ovulation induction in North American, is not FDA approved for this indication. Twin rates with this medication approximate that with Clomid. The risk of triplets with either of these medications is rare, but not unknown.
  • Gonadotrophin therapy or Controlled Ovarian Hyperstimulation uses more physiologic or "natural" medications to induce ovulation. These medications have a much higher predilection for producing multiple pregnancies, particularly in women with Polycystic Ovarian Syndrome.
It is imperative that these cycles be closely monitored with ultrasound and blood tests, and that patients undergoing this therapy be counselled regarding the risk of unprotected intercourse in the treatment cycle until the number of developing follicles can be assessed. Most clinics will not proceed with these cycles unless there are two or fewer developing follicles. There may be extenuating circumstances where conception might be encouraged with three follicles, but that decision would only be made after considering a number of extenuating circumstances. The risk of multiple gestation in this instance should be clearly stated to the patient. In order to lessen the financial burden of these cycles, our clinics provide these cycles using a "global fee," so that couples will be aware of the exact cost of the cycle, regardless of the number of ultrasounds or blood tests required for those cycles.

In some ways In Vitro Fertilization can potentially lead to fewer multiple gestations than COH treatment. The American Association of Reproductive Medicine has published "Guidelines on number of embryos transferred." These are based on CDC/ASRM/ART data available in 2006.

The Guideline reviewed June 2008 includes the following considerations:

"The number of embryos transferred should be agreed upon by the physician and the treated patient(s), informed consent documents completed, and the information recorded in the clinical record. In the absence of data generated by the individual program, and based on data generated by all clinics providing ART services, the following guidelines are recommended.
  • A. For patients under the age of 35 who have a more favorable prognosis, consideration should be given to transferring only single embryo. All others in this age group should have no more than 2 embryos (cleavage-stage or blastocyst) transferred in the absence of extraordinary circumstances.
  • B. For patients between 35 and 37 years of age who have a more favorable prognosis, no more than 2 cleavage-stage embryos should be transferred. All others in this age group should have no more than 3 cleavage-stage embryos transferred. If extended culture is performed, no more than 2 blastocysts should be transferred to women in this age group.
  • C. For patients between 38 and 40 years of age who have a more favorable prognosis, no more than 2 blastocysts should be transferred. All others in this age group should have no more than 4 cleavage-stage embryos or 3 blastocysts transferred.
  • D. For patients greater thana 40 years of age, no more than 5 cleavage-stage embryos or 3 blastocysts hould be transferred.
  • E. For patients with 2 or more previous failed IVF cycles, or a less favorable prognosis, additional embryos may be transferred according to individual circumstances after appropriate consultation.
  • F. In donor egg cycles, the age of the donor should be used to determine the appropriate number of embryos to transfer.
These recommendations are voluntary at the current time. However, if physicians violate these recommendations, it certainly invites future Governmental intervention, and places the physician and program at risk for legal liability.

In summary, then, the ideal goal of fertility treatment should be the production of a healthy, low risk pregnancy. While many circumstances prevail that may mitigate more aggressive therapy, one should never lose sight of the fact that multiple pregnancies are often associated with undesirable outcomes, and that the higher the order of multiples, the greater the risk of poor outcomes.


Mack said...

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