Clinical Trial

Factors Associated With Clinical Pregnancy Outcomes in Intrauterine Insemination (IUI) Cycles

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Summary
Hypotheses: We hypothesize that variations in hormonal profiles (LH, estradiol, progesterone) during ovarian stimulation, follicular response, endometrial characteristics, and sperm quality parameters are significantly associated with clinical pregnancy outcomes in intrauterine insemination (IUI) cycles. Aims * To investigate the association between hormonal profiles on the trigger day (LH, estradiol, progesterone), follicular response, endometrial thickness, and sperm parameters with clinical pregnancy outcomes in IUI cycles. * To develop and validate a predictive model for clinical pregnancy incorporating key determinants such as female age, hormonal response, endometrial characteristics, and sperm quality. * To compare natural and gonadotropin-stimulated IUI cycles in terms of hormonal profiles, pregnancy outcomes, and cost-effectiveness. Primary Outcome Clinical pregnancy rate (CPR), defined as the presence of a gestational sac with a fetal heartbeat on ultrasound at approximately 6 weeks of gestation following intrauterine insemination. Secondary Outcomes * Biochemical pregnancy rate. * Ongoing pregnancy rate * Live birth rate
Protocol Amendment History 1 change
critical Recruitment opened 2026-05-12
Trial Details
NCT Number NCT07344623
Lead Sponsor Chinese University of Hong Kong
Conditions Reproductive Issues
Enrollment 3,000 participants
Start Date 2026-01-13
Primary Completion 2027-07-01 (estimated)
Study Completion 2028-01-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-11