Couples with unexplained infertility seeking treatment at Boston IVF or Harvard Vanguard Medical Associates were screened for eligibility to participate in the randomized, controlled trial. Eligibility criteria included: trying to conceive for 12 months without prior fertility treatment (excepting up to three cycles of clomiphene without intrauterine insemination (IUI)); a female partner 21 to 39 years old with sufficient ovarian reserve and without pelvic pathology; and adequate sperm concentration in the male partner.

Couples enrolled in the study followed either a conventional course of treatment or an accelerated course until they achieved pregnancy or elected to stop treatment. The conventional treatment included three IUI cycles stimulated with clomiphene citrate for ovulation induction, followed by three FSH-stimulated IUI cycles, then up to six cycles of IVF. The accelerated treatment plan omitted the FSH-stimulated cycles and went to IVF after three clomiphene-stimulated IUIs. The couples were followed from the date of their enrollment until the closing date of the study. Charge data obtained from insurers included all healthcare items and services for women during the trial- from the time of randomization through hospital discharge of mother and baby after delivery, or until one year after completing treatment without pregnancy.

Of 503 couples enrolled, 64% delivered at least one baby by the end of the study. Babies were born to 150/247 couples in the conventional treatment group and to 171/256 couples in accelerated treatment. The time to pregnancy was significantly shortened for the couples in the accelerated arm of the study. Those couples achieved pregnancy in an average of eight months compared with an average time to pregnancy of 11 months for couples in the conventional arm.

Insurance charge data were collected for 448 participating couples. Average charges per delivery were $9,800 lower in the accelerated arm than for conventional treatment. Savings of $2,624 per couple were observed in the accelerated treatment arm.

Foregoing gonadotropin-stimulated IUI eliminated not only the charges for that treatment from overall charges, but also reduced the risk of multiple conception and the increased charges associated with multiple pregnancies and births.

Elizabeth Ginsburg, President of the Society for Assisted Reproductive Technology, commented, “This is a very important study that will likely influence physicians to reduce the number of stimulated inseminations for patients with unexplained infertility. Adoption of such an accelerated course of treatment could result in many patients conceiving in less time with less expense.”

Reindollar et al, A randomized clinical trial to evaluate optimal treatment for unexplained infertility: the fast track and standard treatment (FASTT) trial, Fertility and Sterility, in press.

The American Society for Reproductive Medicine, founded in 1944, is an organization of more than 8,000 physicians, researchers, nurses, technicians and other professionals dedicated to advancing knowledge and expertise in reproductive biology. Affiliated societies include the Society for Assisted Reproductive Technology, the Society for Male Reproduction and Urology, the Society for Reproductive Endocrinology and Infertility and the Society of Reproductive Surgeons.


Topics #Clinical Trial #Infertility Treatment