The Effects of Male Factors on the Success Rate of in Vitro Fertilization. Will Deposition of Seminal Plasma Around the External Cervical os Increase Pregnancy Rate?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,600
- 试验地点
- 2
- 主要终点
- Pregnancy rate
研究概览
简要总结
All couples planned for IVF will be asked to participate. After information and received informed consent they will be randomized into two groups.
At the time for ovum pick up during an IVF procedure either half of the amount of seminal plasma or the same amount of physiological NaCl solution will be installed around the external cervical opening in vagina. The syringe with seminal plasma or physiological NaCl solution will be prepared according to a prearranged randomization list by a technician.
The success rate will be the number of diagnosed pregnancies and live births.
详细描述
All couples planned for IVF will be asked to participate. After information and received informed consent they will be randomized into two groups.
At the time for ovum pick up during an IVF procedure either half of the amount of seminal plasma or the same amount of physiological NaCl solution will be installed around the external cervical opening in vagina.
Normally we do not use the seminal plasma but now half of it will be installed and the other half analysed regarding a number of cytokines possibly involved in the immunological preparation of the female internal genitalia.
The syringe with seminal plasma or physiological NaCl solution will be prepared according to a prearranged randomization list by a technician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •subjects have given informed consent
- •infertility for at least 1 year
- •the couple wishing IVF
- •subjects aged between 20 - 40 years
- •Exclusion criterion:
- •azoospermia
排除标准
- 未提供
结局指标
主要结局
Pregnancy rate
时间窗: 40 weeks
Pregnancy as a viable fetus at ultrasonography around week 12 and delivery of baby
次要结局
- Cytokine content(40 weeks)
研究者
Elizabeth Nedstrand
MD, PhD
Ostergotland County Council, Sweden