Factors Associated With Clinical Pregnancy Outcomes in Intrauterine Insemination (IUI) Cycles
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Reproductive Issues. Basic parameters: 18 years — 42 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Primary outcome measures
- 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.]
Secondary outcome measures (3)
- Biochemical pregnancy rate [Time frame: Up to 12 weeks]
- Ongoing pregnancy rate [Time frame: Up to 12 weeks]
- live birth rate [Time frame: Up to 40 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
China · 1 center
- The Chinese University of Hong Kong — Hong Kong
Identifiers
NCT: NCT07344623 · 2025.831