Factors Associated With Clinical Pregnancy Outcomes in In... | NCT07344623

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

NCT07344623

Sponsor

Chinese University of Hong Kong

Status

Recruiting

Last Update Posted

May 11, 2026Actual

Enrollment

3,000Estimated

Phase

Not provided

Conditions

Reproductive Issues

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 13, 2026Actual

Primary Completion Date

Jul 1, 2027Estimated

Completion Date

Jan 1, 2028Estimated

First Submitted Date

Dec 30, 2025

First Submission Date that Met QC Criteria

Jan 13, 2026

First Posted Date

Jan 15, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 8, 2026

Last Update Posted Date

May 11, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chung Pui Wah Jacqueline, Associate Professor, Chinese University of Hong KongPrincipal Investigator

Lead Sponsor

Chinese University of Hong KongOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical pregnancy rate (CPR)	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

42 Years

Standard Ages

Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Chinese University of Hong Kong	Recruiting	Hong Kong			China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided