A Prospective, Randomized, Double-Blind, Controlled Clinical Trial of the Effects of Oxygen Tension on Clinical In Vitro Fertilization Outcomes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 851
- 试验地点
- 8
- 主要终点
- The primary outcome is live birth rate.
研究概览
简要总结
Primary Aim
- Evaluate whether human embryo exposure to physiologic levels of oxygen during culture improves the percentage of women who deliver a baby following in vitro fertilization and embryo transfer.
Hypothesis to be tested: Physiologic oxygen tension during embryo culture, which approximates the oxygen tension in the fallopian tube and uterus, improves live birth rate in clinical In Vitro Fertilization Embryo Transfer (IVF-ET).
Secondary Aims
Evaluate whether human embryo exposure to physiologic levels of oxygen during culture during in vitro fertilization and embryo transfer
- improves embryo cleavage
- improves clinical pregnancy rate
- reduces multiple pregnancy rate
- reduces miscarriage rate
Hypothesis to be tested: Physiologic oxygen tension during embryo culture, which approximates the oxygen tension in the fallopian tube and uterus, improves embryo cleavage and clinical pregnancy rates and reduces miscarriage rates in clinical IVF-ET.
详细描述
Study Design
This will be a multi-center, prospective, double-blind clinical trial of physiologic (5%) oxygen tension in culture media vs. standard of care, atmospheric (SOC, 20%) oxygen tension with 840 eligible couples recruited to participate. The randomization scheme will be coordinated through the central data coordinating center (DCC-Yale) and the randomization will be stratified by age group of the woman (18-34, 35-37, 38-40 and 40-42) and each participating site.
Treatment
Couples will be randomized to either have their gametes and embryos placed in a physiologic (5%) oxygen atmosphere or in the currently widely used atmospheric (20%) oxygen atmosphere.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The critical inclusion criteria will be the diagnosis of infertility and the need for in vitro fertilization as determined by the treating clinician. (We do not plan to alter the standard of care for the indication for IVF at any of the sites.)
- •Couple's age must be between 18 and 42 years old
- •Patient and partner are scheduled to undergo in vitro fertilization for treatment of infertility
- •Couple able to participate in a research project and A) Able to understand study requirements B) Willing to sign informed consent C) Able to return for required follow-up D) Have access to telephone
排除标准
- •Critical exclusion criteria for this trial will be medical conditions which may complicate treatment or no plans to undergo embryo transfer, as in patients banking embryos prior to cancer therapy. In addition, donor egg and frozen embryo transfer cycles will be excluded.
- •Medical contraindication to egg retrieval or pregnancy
- •Inability to participate in a research project (Non-English speaking or unable to read or write and/or concurrent participation in any other interventional trial)
- •Couple with more than three previous failed IVF cycles
- •Donor egg and frozen embryo transfer cycles
结局指标
主要结局
The primary outcome is live birth rate.
时间窗: 2 years
次要结局
- The impact of treatment on embryo cleavage(2 years)
- The impact of treatment on multiple pregnancy(2 years)
- The impact of treatment on clinical pregnancy(2 years)
- The impact of treatment on miscarriage(2 years)
研究者
Heping Zhang
Principal Investigator
Yale University