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

The Chinese University of Hong Kong

Status: Not yet enrolling

Conditions: Reproductive Issues

Study type: Observational

Funder types: Other

Identifiers

NCT07344623

2025.831

Details and patient eligibility

About

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

Full 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

Enrollment: 3,000 estimated patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Couples who underwent at least one IUI-intrauterine insemination cycle.

Exclusion criteria

• Couples who used donor sperm.
• Cases with missing core outcome data