Objectives: TO determine whether a supplementary folliclestimulating hormone (FSH) bolus given at the time of the human chorionic gonadotropin (hCG) trigger can improve the pregnancy and live birth rates in women with unexplained infertility (UI) underwent letrozole stimulated intrauterine insemination (IUI). Design: A randomized controlled trial. Patients and methods: One-hundred and eight women with primary unexplained infertility underwent combined letrozole superovulation and IUI. At the time of ovulation triggering patients were randomized into hCG trigger alone (Control group) versus combined FSH plus hCG trigger (Study group). Primary outcome included the clinical pregnancy and the live birth rates. Secondary outcomes included the frequency of ovarian hyperstimulation syndrome (OHSS), multiple gestations, and abortion. Results: Significantly higher pregnancy rates pre-cycle (12.5% vs. 5.8%: p=0.049) and per-woman (33.33% vs. 16.67%: p=0.049) and live birth rate (29.6% vs. 12.5%; p= 0.039) were noted in the study group compared to the control group. Abortion occurred in 2 out of 18 pregnancies (11.11 %) in the study group and in 2 out of 9 pregnancies (22.22 %) in the control group with no significant difference. No case of multiple gestations or OHSS reported in either group. Conclusion: Ovulation trigger with the dual administration of FSH and hCG compared to hCG alone significantly increased clinical pregnancy rate and the live birth rate in women with unexplained infertility underwent combined letrozole superovulation and IUI.
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