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Effect of Intrauterine Insemination on Subsequent Pregnancy Outcomes in Couples With Unexplained Pregnancy Loss: A Multicenter, Open-label, Randomized Controlled Trial

NCT07759609 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 558

Last updated 2026-08-12

No results posted yet for this study

Summary

Unexplained pregnancy loss remains a major reproductive challenge, and effective management strategies for affected couples are limited. Although intrauterine insemination (IUI) is widely used in reproductive medicine, its effectiveness in improving subsequent pregnancy outcomes among couples with unexplained pregnancy loss has not been well established.

This multicenter, open-label, randomized controlled trial aims to evaluate whether IUI improves subsequent pregnancy outcomes compared with natural conception in couples with unexplained pregnancy loss. A total of 558 eligible couples will be enrolled and randomly assigned to either an IUI group or a natural conception group. Participants will be followed to assess reproductive outcomes. The findings of this study are expected to provide high-quality evidence regarding the role of IUI in the management of unexplained pregnancy loss and to inform future clinical practice.

Conditions

  • Unexplained Pregnancy Loss

Interventions

PROCEDURE

Intrauterine Insemination (IUI)

Participants assigned to the intervention group undergo intrauterine insemination (IUI) according to the study protocol. Processed sperm is placed into the uterine cavity during the periovulatory period to improve the likelihood of conception.

Sponsors & Collaborators

  • Lanzhou University Second Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
37 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-27
Primary Completion
2027-12-01
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07759609 on ClinicalTrials.gov