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

May 8, 2026 updated by: Chung Pui Wah Jacqueline, Chinese University of Hong Kong

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

Study Overview

Status

Recruiting

Conditions

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

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This retrospective study will include all infertile couples who underwent intrauterine insemination (IUI) at the Asisted Reproductive Unit, Department of Obstetrics and Gynaecology, Prince of Wales Hospital, Hong Kong, China

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Outcome Measure
Measure Description
Time Frame
Biochemical pregnancy rate
Time Frame: Up to 12 weeks
Rate of biochemical pregnancy outcome in subjects undergoing IUI
Up to 12 weeks
Ongoing pregnancy rate
Time Frame: Up to 12 weeks
Rate of Ongoing pregnancy outcome in subjects undergoing IUI
Up to 12 weeks
live birth rate
Time Frame: Up to 40 weeks
Rate of live birth rate outcome in subjects undergoing IUI
Up to 40 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

December 30, 2025

First Submitted That Met QC Criteria

January 13, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2025.831

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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