It is well known that there is a significant decline in fertility after age 35. The standard of care for women 35 and older who are having difficulty achieving pregnancy is to consult a fertility specialist if, after six months of trying (i.e. unprotected intercourse), pregnancy has not been achieved.
Based upon the increasing number of patients in this age group who are being seen earlier in the treatment process, it is clear to us at RMA that the general OBGYN community has become increasingly sensitive to the needs of these patients and the benefits of seeing a specialist sooner rather than later. For us, the physicians at RMA, the initial question we need to answer is how aggressive should we be with our new patients, if no treatment has been tried, prior to arriving in our offices?
Fortunately the physicians at Boston IVF, conducted a study that has made treatment options for these patients a little clearer. In a randomized clinical trial (the FORT Trial), 154 couples were assigned to one of three treatment groups. One group went straight to IVF, while the other two groups utilized oral medication (clomiphene citrate) with intrauterine insemination (IUI) or injectable medication (follicle stimulating hormone FSH) with IUI. Those couples who did not conceive in two cycles of oral or injectable medication, moved on to in vitro fertilization (IVF) for all future cycles.
In order to be included in the study, couples had to have tried achieving pregnancy for at least six months without any prior exposure to the study medications. The female partner had to be between 38-42 years old, have regular menstrual cycles, good ovarian reserve, and no abnormalities of the reproductive tract. The male partner had to have a normal number of motile sperm.
The results were quite striking. The group that went straight to IVF had a 49% pregnancy rate with 31% giving birth. Of those who took oral medication 22% became pregnant with a 16% birth rate, while those in the injectable medication group had a 17% pregnancy rate with 14% live birth rate. Those who started with IVF averaged two cycles to conceive, while the groups who were started on ovulation drugs averaged 3-4 cycles to conceive.
What we learn from this study is that starting with IVF initially in older couples is the most effective form of treatment. Equally important, if a couple chooses to try ovulation medication with IUI and forego IVF; oral drugs are just as effective as injectable medication in leading to pregnancy. An important side note—at RMA, many of our older patients undertaking IVF have extra embryos to freeze for future family building, which is important for those patients who want to have more children in the future.
While the sample size of this study is not extremely large, the early data are quite helpful in directing our patients to the best pathway for achieving a pregnancy. We are looking forward to larger studies that will also confirm that moving to IVF quickly in the older infertility population will lead to a positive outcome.