Reproductive Issues
Conditions
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. Sample Size All eligible IUI cycles, estimated to be approximately 3000 cycles, will be included
Interventions
None listed
Sponsors
Chinese University of Hong Kong
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 42 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy rate (CPR) | 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
| Measure | Time frame | Description |
|---|---|---|
| Biochemical pregnancy rate | Up to 12 weeks | Rate of biochemical pregnancy outcome in subjects undergoing IUI |
| Ongoing pregnancy rate | Up to 12 weeks | Rate of Ongoing pregnancy outcome in subjects undergoing IUI |
| live birth rate | Up to 40 weeks | Rate of live birth rate outcome in subjects undergoing IUI |
Countries
China
Outcome results
None listed