NCT07344623

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: Female
• Age: 18 Years – 42 Years
• Healthy volunteers: Not accepted

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

Detailed description

Statistical Analysis Each sub-study will employ specific analytical approaches: * Univariate and multivariate logistic regression for associations * Mediation and interaction analysis * ROC and AUC analysis for predictive modeling * Machine learning for model development * Cost-effectiveness evaluated via incremental cost per clinical pregnancy Consent This is a retrospective study, and thus, there is no need for a written informed consent. Sample Size All eligible IUI cycles, estimated to be approximately 3000 cycles, will be included

Conditions

• Reproductive Issues

Timeline

• Start date: 2026-01-13
• Primary completion: 2027-07-01
• Completion: 2028-01-01
• First posted: 2026-01-15
• Last updated: 2026-01-15

Locations

1 site across 1 country: China