Comparing Letrozole Alone Versus Combined Letrozole and Clomiphene Citrate for Ovulation Induction in Women Aged 18 to 40 With Ovulation Disorders

What this Trial Is About

Researchers are evaluating whether combining letrozole LE and clomiphene citrate CC leads to higher live birth rates than using letrozole alone in infertile women with WHO IIIV ovulatory disorders. This open-label randomized controlled trial is conducted across six fertility clinics in Vietnam. The study aims to recruit 600 women aged 18 to 40 years to compare live birth outcomes after one treatment cycle. Participants are randomly assigned to one of two groups one receiving a combination of 5 mg letrozole and 50 mg clomiphene citrate daily, and the other receiving 5 mg letrozole alone. Both treatments are given for five consecutive days starting from the second to fourth day of the menstrual cycle. Ovulation induction involves ultrasound monitoring of ovarian follicles and endometrial thickness, and ovulation is triggered with an injection of human chorionic gonadotropin hCG. Intrauterine insemination IUI or natural intercourse is scheduled based on physician and patient preferences. Women who join the study will undergo screening for eligibility, provide informed consent, and have blood samples taken for hormone and biochemical analysis. Throughout the treatment cycle, participants will receive ultrasound assessments and hormone monitoring. The primary outcome measured is live birth after one treatment cycle, with secondary outcomes including ovulation rates, pregnancy tests, pregnancy progression, birth outcomes, and safety events. The study includes follow-up through pregnancy to assess these outcomes.

LE + CC vs. LE for Ovulation Induction