Factors Associated With Clinical Pregnancy Outcomes in Intrauterine Insemination (IUI) Cycles
NCT ID: NCT07344623
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
3000 participants
OBSERVATIONAL
2026-01-13
2028-01-01
Brief Summary
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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
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Detailed Description
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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
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Study Design
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OTHER
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Cases with missing core outcome data
18 Years
42 Years
FEMALE
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Chung Pui Wah Jacqueline
Associate Professor
Locations
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The Chinese University of Hong Kong
Hong Kong, , China
Countries
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Facility Contacts
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Other Identifiers
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2025.831
Identifier Type: -
Identifier Source: org_study_id
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