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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Eligibility

Primary outcome measure(s)

• Early Miscarriage Rate — From randomization until 10 weeks of gestation
  The proportion of women who experience pregnancy loss before 10 weeks of gestation among those achieving pregnancy.

Trial sites (3)

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