Abstract
To identify baseline characteristics of women with unexplained infertility to determine whether treatment with an aromatase inhibitor will result in a lower rate of multiple gestations than current standard ovulation induction medications. Randomized, prospective clinical trial. Multicenter university-based clinical practices. A total of 900 couples with unexplained infertility. Collection of baseline demographics, blood samples, and ultrasonographic assessments. Demographic, laboratory, imaging, and survey characteristics. Demographic characteristics of women receiving clomiphene citrate (CC), letrozole, or gonadotropins for ovarian stimulation were very consistent. Their mean age was 32.2 ± 4.4 years and infertility duration was 34.7 ± 25.7 months, with 59% primary infertility. More than one-third of the women were current or past smokers. The mean body mass index (BMI) was 27 and mean antimüllerian hormone level was 2.6; only 11 women (1.3%) had antral follicle counts of <5. Similar observations were identified for hormonal profiles, ultrasound characterization of the ovaries, semen parameters, and quality of life assessments in both male and female partners. The cause of infertility in the couples recruited to this treatment trial is elusive, as the women were regularly ovulating and had evidence of good ovarian reserve both by basal FSH, antimüllerian hormone levels, and antral follicle counts; the male partners had normal semen parameters. The three treatment groups have common baseline characteristics, thereby providing comparable patient populations for testing the hypothesis that use of letrozole for ovarian stimulation can reduce the rates of multiples from that observed with gonadotropin and CC treatment. NCT 01044862.
Highlights
In regularly ovulating women with unexplained infertility, a frequently chosen option that has been shown to enhance the likelihood of conception is empiric ovulation induction [1,2,3,4]
The three treatment subgroups have common baseline characteristics, thereby providing comparable patient populations for testing the hypothesis that use of letrozole for ovarian stimulation can reduce the rates of multiples from that observed with gonadotropin and clomiphene citrate treatment
A major challenge of ovulation induction in the United States has been the increased incidence of multiple births associated with the administration of fertility promoting agents, including gonadotropins and clomiphene citrate (CC)(5, 6) Multiple gestations following the use of these agents are associated with increased risk for preterm labor, preterm delivery, antepartum maternal hospitalization, and neonatal morbidity and mortality associated with preterm delivery [7,8,9,10] A direct result of the prolonged maternal and neonatal hospitalizations is the marked increase in expense related to this intensive care,(11, 12) and an overall increased risk for lifelong morbidity for these babies
Summary
In regularly ovulating women with unexplained infertility, a frequently chosen option that has been shown to enhance the likelihood of conception is empiric ovulation induction [1,2,3,4]. The use of AIs would lead to both a reduction in multi-fetal pregnancies and the potential maternal and long-term neonatal morbidity associated with them, and a decrease in the significant, short-term morbidity associated with ovarian hyperstimulation syndrome (OHSS). To examine these major clinical issues, the Eunice Kennedy Shriver National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network (RMN) conducted the Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS) clinical trial. This report summarizes the baseline demographic, biomedical, and quality of life survey characteristics of nine hundred male and female partners who participated in the AMIGOS trial
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