Effect of Intrauterine Insemination on Subsequent Pregnancy Outcomes in Couples With Unexplained Pregnancy Loss: A Multicenter, Open-label, Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 558
- Locations
- 3
- Primary Endpoint
- Early Miscarriage Rate
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 37 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •Anti-Müllerian hormone (AMH) >1.1 ng/mL.
- •Male partner's semen analysis meeting the criteria for intrauterine insemination (IUI), with a post-processing total progressive motile sperm count ≥5 × 10⁶.
- •Ability and willingness to provide written informed consent.
Exclusion Criteria
- •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.
- •Participation in another interventional clinical trial during the study period.
Arms & Interventions
Natural Conception
Participants attempt natural conception without intrauterine insemination.
Intrauterine Insemination (IUI)
Participants undergo intrauterine insemination after randomization to improve the probability of conception.
Intervention: Intrauterine Insemination (IUI) (Procedure)
Outcomes
Primary Outcomes
Early Miscarriage Rate
Time Frame: From randomization until 10 weeks of gestation
The proportion of women who experience pregnancy loss before 10 weeks of gestation among those achieving pregnancy.
Secondary Outcomes
- Clinical Pregnancy Rate(From randomization until clinical pregnancy assessment (6-8 weeks of gestation))
- Live Birth Rate(From randomization until delivery (approximately 40 weeks of gestation))
- Preterm Birth Rate(From randomization until delivery (approximately 40 weeks of gestation))
- Adverse Event Rate(From enrollment until completion of study follow-up (approximately 40 weeks of gestation))
Investigators
Fang Wang
Lanzhou University Second Hospital
Lanzhou University Second Hospital