Assessment of multiple intrauterine gestations from ovarian stimulation (AMIGOS) trial: baseline characteristics

Abstract

Objective 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. Design Randomized, prospective clinical trial Patients 900 couples with unexplained infertility Interventions: Ovarian stimulation with gonadotropins, clomiphene citrate, or letrozole in conjunction with intrauterine insemination. Setting Multicenter University based clinical practices. Main Outcome Measures Demographic, laboratory, imaging, and survey characteristics. Interventions Collection of baseline demographics, blood samples, and ultrasonographic assessments. Results Demographic characteristics of women receiving clomiphene citrate, 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 1/3 of the women were current or past smokers. The mean BMI was 27 and mean AMH level was 2.6; only 11 women (1.3%) had antral follicle counts of less than 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. Conclusion 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, AMH levels, and antral follicle counts; the male partners had normal semen parameters. 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.

Letrozole, Gonadotropin, or Clomiphene for Unexplained Infertility

“…S1 and S2 in the Supplementary Appendix). Baseline characteristics have been reported previously 24 and are presented in Table 1; baseline characteristics in the per-protocol analysis are provided in Table S1 in the Supplementary Appendix. Treatment-cycle cancellation rates were 6.9% for gonadotropin, 3.3% for clomiphene, and 3.7% for letrozole (P<0.001 for differences among the three groups) (see Table S2 in the Supplementary Appendix for reasons for cycle cancellation).…”

“… * Data are from Diamond et al 24 Plus–minus values are means ±SD. There were no significant differences (P<0.05) among the three groups in any of the baseline characteristics.…”

Association of uterine fibroids and pregnancy outcomes after ovarian stimulation–intrauterine insemination for unexplained infertility

“…Study participants were women ≥18 to ≤ 40 years of age, with regular menses (9 or more per year), a normal uterine cavity, at least one patent fallopian tube, and a male partner with an ejaculated semen specimen of at least 5 million motile sperm. A complete description of study design, inclusion and exclusion criteria, statistical analyses, baseline characteristics, endocrine assays, and treatment outcomes of participants has been previously reported (27, 32, 33). Institutional Review Board approval was obtained at each study site and all participants provided informed consent prior to participation.…”

“…Baseline demographic and reproductive characteristics from all screening ultrasound examinations were recorded for the original study (27, 32). A normal uterine cavity contour and patency of at least one fallopian tube was confirmed with either hysterosalpingogram or sonohysterogram prior to inclusion in the study (32).…”

“…A normal uterine cavity contour and patency of at least one fallopian tube was confirmed with either hysterosalpingogram or sonohysterogram prior to inclusion in the study (32). Uterine fibroid measurements were recorded in three dimensions with standard 7.5 MHz transvaginal ultrasound examination and the uterine volume (cubic centimeters [cm 3 ]) and the volume (cm 3 ) of the largest fibroid (if present) were recorded for each participant prior to the first treatment visit during study screening (33).…”