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

NCT07344623 | Not Yet Recruiting DMC

• 1 other identifier: 2025.831
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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

Conditions

Reproductive Issues

Outcome Measures

Primary Outcomes (1)

• 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 (3)

• Biochemical pregnancy rate

  Up to 12 weeks

• Ongoing pregnancy rate

  Up to 12 weeks

• live birth rate

  Up to 40 weeks

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• Couples who underwent at least one IUI-intrauterine insemination cycle.

You may not qualify if:

• Couples who used donor sperm.
• Cases with missing core outcome data

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, China

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 15, 2026
• Study Start: January 13, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

CN (1)