Factors Associated With Clinical Pregnancy Outcomes in Intrauterine Insemination (IUI) Cycles
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 3,000
- Locations
- 1
- Primary Endpoint
- Clinical pregnancy rate (CPR)
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 42 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Clinical pregnancy rate (CPR)
Time Frame: 6 weeks gestation and ultrasound scanning will be performed to confirm at least one gestational sac around 2 to 3 months after IUI.
Rate of clinical pregnancy outcome in subjects undergoing IUI
Secondary Outcomes
- Biochemical pregnancy rate(Up to 12 weeks)
- Ongoing pregnancy rate(Up to 12 weeks)
- live birth rate(Up to 40 weeks)
Investigators
Chung Pui Wah Jacqueline
Associate Professor
Chinese University of Hong Kong