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NCT Number: NCT07344623

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

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

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Key information

Conditions

Reproductive Issues

Age range

18 year–42 year

Sex eligibility

Female

Study type

Observational

Primary location

The Chinese University of Hong Kong

Hong Kong, China

Location status: Recruiting

Location contact

Chung PW Jacqueline

CONTACT

[email protected]

35053489

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Biochemical pregnancy rate

    Time frame: Up to 12 weeks

    Rate of biochemical pregnancy outcome in subjects undergoing IUI

  2. Ongoing pregnancy rate

    Time frame: Up to 12 weeks

    Rate of Ongoing pregnancy outcome in subjects undergoing IUI

  3. live birth rate

    Time frame: Up to 40 weeks

    Rate of live birth rate outcome in subjects undergoing IUI

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 15, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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