Effect of Intrauterine Insemination on Subsequent Pregnancy Outcomes in Couples With Unexplained Pregnancy Loss: A Multicenter, Open-label, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 558
- 试验地点
- 3
- 主要终点
- Early Miscarriage Rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Natural Conception
Participants attempt natural conception without intrauterine insemination.
Intrauterine Insemination (IUI)
Participants undergo intrauterine insemination after randomization to improve the probability of conception.
干预措施: Intrauterine Insemination (IUI) (Procedure)
结局指标
主要结局
Early Miscarriage Rate
时间窗: From randomization until 10 weeks of gestation
The proportion of women who experience pregnancy loss before 10 weeks of gestation among those achieving pregnancy.
次要结局
- 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))
研究者
Fang Wang
Lanzhou University Second Hospital
Lanzhou University Second Hospital