Actively Recruiting

Age: 18Years - 42Years
FEMALE
ID07344623

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

Led by Chinese University of Hong Kong · Updated on 2026-05-11

3000

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying factors that may affect clinical pregnancy outcomes in intrauterine insemination (IUI) cycles, focusing on hormonal profiles such as luteinizing hormone (LH), estradiol, and progesterone, as well as follicular response, endometrial thickness, and sperm quality. The research aims to develop a predictive model for pregnancy success and compare natural versus gonadotropin-stimulated IUI cycles regarding hormonal changes, pregnancy outcomes, and cost-effectiveness. This observational study includes approximately 3000 eligible IUI cycles and is sponsored by the Chinese University of Hong Kong. The study analyzes hormonal levels on the trigger day of IUI cycles along with other key factors like female age and sperm quality. Statistical methods such as logistic regression, mediation and interaction analyses, ROC and AUC analyses, and machine learning will be applied to understand associations and develop predictive models. The comparison between natural and stimulated cycles will also assess incremental costs per clinical pregnancy. Participants' clinical pregnancy will be confirmed by ultrasound scanning at about 6 weeks gestation to detect a gestational sac with a fetal heartbeat. Secondary outcomes include biochemical and ongoing pregnancy rates up to 12 weeks and live birth rates up to 40 weeks. As a retrospective study, no written informed consent is required. The study does not involve interventions or treatments but collects and analyzes data from past IUI cycles to identify outcome predictors and cost-effectiveness.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 42Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Couples who underwent at least one IUI-intrauterine insemination cycle.
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Up to 12 weeks

Participants who underwent intrauterine insemination (IUI) cycles are evaluated for clinical pregnancy outcomes through ultrasound scanning and biochemical tests.

1 to 2 visits including ultrasound and biochemical assessments

Long-term Monitoring

Duration - Up to 40 weeks

Participants are monitored for ongoing pregnancy and live birth outcomes following IUI cycles.

Periodic assessments up to 40 weeks after IUI

Trial Site Locations

Total: 1 location

1

The Chinese University of Hong Kong

Hong Kong, China

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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