Effect of Intrauterine Insemination on Subsequent Pregnancy Outcomes in Couples With Unexplained Pregnancy Loss: A Multicenter, Open-label, Randomized Controlled Trial
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.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Fang Wang, PhD
- 电话号码：+86 13919302888
- 邮箱：ery_fwang@lzu.edu.cn
学习地点
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Beijing Municipality
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Beijing、Beijing Municipality、中国
- 尚未招聘
- Beijing Amcare Beisanhuan Women's & Children's Hospital
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接触：
- Xinna Chen
- 电话号码：+8613501207016
- 邮箱：xinnachen70@hotmail.com
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Gansu
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Lanzhou、Gansu、中国
- 招聘中
- Lanzhou university second hosipital
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接触：
- Fang Wang, PhD
- 电话号码：+86 13919302888
- 邮箱：ery_fwang@lzu.edu.cn
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Hebei
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Shijiazhuang、Hebei、中国
- 尚未招聘
- Hebei Reproductive Health Hospital
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接触：
- Lirong Du
- 电话号码：+86 18533118669
- 邮箱：lirongdu@sina.cn
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：Natural Conception
Participants attempt natural conception without intrauterine insemination.
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实验性的：Intrauterine Insemination (IUI)
Participants undergo intrauterine insemination after randomization to improve the probability of conception.
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Early Miscarriage Rate
大体时间：From randomization until 10 weeks of gestation
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The proportion of women who experience pregnancy loss before 10 weeks of gestation among those achieving pregnancy.
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From randomization until 10 weeks of gestation
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Clinical Pregnancy Rate
大体时间：From randomization until clinical pregnancy assessment (6-8 weeks of gestation)
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Clinical pregnancy confirmed by ultrasonographic visualization of an intrauterine gestational sac.
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From randomization until clinical pregnancy assessment (6-8 weeks of gestation)
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Live Birth Rate
大体时间：From randomization until delivery (approximately 40 weeks of gestation)
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Delivery of a live infant after 24 weeks of gestation.
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From randomization until delivery (approximately 40 weeks of gestation)
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Preterm Birth Rate
大体时间：From randomization until delivery (approximately 40 weeks of gestation)
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Delivery occurring between 28 and 37 completed weeks of gestation.
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From randomization until delivery (approximately 40 weeks of gestation)
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Adverse Event Rate
大体时间：From enrollment until completion of study follow-up (approximately 40 weeks of gestation)
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Occurrence of adverse events including ovarian hyperstimulation syndrome, infection, and other treatment-related complications.
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From enrollment until completion of study follow-up (approximately 40 weeks of gestation)
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2025A-1361
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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