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.
Female participants aged 20-37 years.
History of at least one ultrasound-confirmed pregnancy loss (excluding biochemical pregnancy, ectopic pregnancy, and hydatidiform mole), with the most recent pregnancy loss occurring within the previous 12 months.
Desire for pregnancy at the time of enrollment.
Basal follicle-stimulating hormone (FSH) <10 IU/L.
Congenital or acquired uterine structural abnormalities.
Thyroid dysfunction, defined as thyroid-stimulating hormone (TSH) >4.0 mIU/L.
Positive antiphospholipid antibodies, including lupus anticoagulant, anticardiolipin antibodies, or anti-β2 glycoprotein I antibodies.
Parental chromosomal abnormalities or a history of fetal chromosomal abnormalities in a previous pregnancy.
Parallel
Intrauterine Insemination (IUI)
Procedure/SurgeryParticipants 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.
Early Miscarriage Rate
The proportion of women who experience pregnancy loss before 10 weeks of gestation among those achieving pregnancy.
Clinical Pregnancy Rate
Clinical pregnancy confirmed by ultrasonographic visualization of an intrauterine gestational sac.
Live Birth Rate
Delivery of a live infant after 24 weeks of gestation.
Preterm Birth Rate
Delivery occurring between 28 and 37 completed weeks of gestation.
Adverse Event Rate
Occurrence of adverse events including ovarian hyperstimulation syndrome, infection, and other treatment-related complications.
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