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

NCT ID: NCT07344623

Last Updated: 2026-01-15

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-13

Study Completion Date

2028-01-01

Brief Summary

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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

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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

Conditions

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Reproductive Issues

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Chung Pui Wah Jacqueline

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Chinese University of Hong Kong

Hong Kong, , China

Site Status

Countries

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China

Facility Contacts

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Chung PW Jacqueline

Role: primary

Other Identifiers

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2025.831

Identifier Type: -

Identifier Source: org_study_id

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