A Double-Blinded Prospective Randomized Clinical Trial Comparing Euploidy Rates Among Embryos Created From Sibling Oocytes Exposed to Sperm After Ultrashort Abstinence Compared With Standard Abstinence
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 187
- 试验地点
- 2
- 主要终点
- Euploidy rate per oocyte
研究概览
简要总结
This research is being done to determine if producing sperm after an ultrashort period of abstinence (1 hour of abstinence) will be effective in improving the rates of embryos with normal chromosomes (structures that carry genetic information) during in vitro fertilization (IVF) treatment. The investigators hypothesize that a shorter period of abstinence is effective at improving rates of normal chromosomes among embryos.
详细描述
As part of the in vitro fertilization (IVF) process, eggs are removed from the ovaries and are inseminated (mixed) or injected with sperm. Typically, sperm samples for IVF are produced on the day of egg retrieval. The current recommendation for abstinence prior to providing this sample is 2-7 days. However, new research has shown that there may be improved IVF outcomes with a shorter period of abstinence including improved integrity of sperm DNA (called sperm DNA fragmentation), sperm parameters (such as motility and shape), embryo quality, implantation rates, pregnancy rates, and live birth rates. One small study found that shorter abstinence may even lead to a higher rate of chromosomally normal embryos.
The purpose of this research study is to determine whether using an ultrashort period of abstinence increases the rates of embryos with normal chromosomes. On the day of egg retrieval, participants will produce two semen samples. The first sample will be collected after 2-5 days of abstinence (standard abstinence). The second sample will be collected 1 hour after the first sample (ultrashort abstinence). Both of these samples will be used for IVF.
At the time of egg retrieval, participants will have their eggs randomized (like the flip of a coin) into two groups. Half of the eggs will be exposed to sperm produced after 2-5 days of abstinence (standard abstinence). The other half of the eggs will be exposed to sperm produced after 1 hour of abstinence (ultrashort abstinence). The goal is to determine the rate of embryos with normal chromosomes in each group. Other goals include looking at how many patients get pregnant after embryo transfer.
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)
盲法说明
Participants, clinical providers, investigators and outcome assessors will be blinded to outcomes.
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
- •Subjects are nonpregnant females ≥ 18 years and ≤ 42 years of age.
- •Subjects obtain greater than or equal to 6 mature oocytes at the time of oocyte retrieval for ICSI or greater than or equal to 8 oocytes at the time of oocyte retrieval for standard insemination.
- •Subjects are utilizing standard insemination or ICSI for fertilization.
- •Subjects are undergoing PGT-A (PGT for aneuploidy) or PGT-M (PGT for monogenic disorders).
- •Subjects are willing to comply with study protocol and procedures and provide written informed consent.
排除标准
- •Subjects are utilizing donor oocytes, donor sperm, or gestational carrier.
- •Subjects have a diagnosis of cryptozoospermia (no spermatozoa identified in fresh semen sample).
- •Subjects are utilizing surgically removed sperm (e.g. via testicular sperm aspiration [TESA] or microsurgical epididymal sperm aspiration [MESA]).
- •Subjects are utilizing frozen/thawed sperm, including in cases in which a fresh sample was planned and the sample is insufficient for use.
- •Subjects are utilizing frozen/thawed oocytes.
- •Subjects undergoing PGT-SR (PGT for structural rearrangements).
- •Subjects are undergoing a day 3 (cleavage stage) embryo transfer.
- •Subjects obtain less than 6 mature oocytes at the time of oocyte retrieval for ICSI or less than 8 oocytes at the time of oocyte retrieval for standard insemination.
- •Subjects obtain greater than or equal to 6 mature oocytes at the time of oocyte retrieval for ICSI or greater than or equal to 8 oocytes at the time of oocyte retrieval for standard insemination but choose to fertilize fewer than 6 (for ICSI) or 8 (for standard insemination).
- •Male partner is unable to produce a second semen sample within three hours of the first semen sample (standard abstinence sample)
- •Male partner has an infectious disease.
研究组 & 干预措施
Standard abstinence
Half of participants eggs will be exposed to sperm produced after standard abstinence (2-5 days of abstinence).
干预措施: Standard abstinence (Other)
Ultrashort abstinence
Half of participants eggs will be exposed to sperm produced after ultrashort abstinence (1 hour of abstinence).
干预措施: Ultrashort abstinence (Other)
结局指标
主要结局
Euploidy rate per oocyte
时间窗: Within 2-4 weeks of IVF cycle
Rate of embryos with normal chromosomes in both groups
Euploidy rate
时间窗: Within 2-4 weeks of IVF cycle
Rate of embryos with normal chromosomes in both groups
次要结局
- Pregnancy rates after transfer of euploid embryos(Within 1-2 weeks of transfer)
- Fertilization rate(Within 1 - 2 weeks of IVF cycle)
- Blastulation rate(Within 2-3 weeks of IVF cycle)
研究者
Lawrence Engmann
Principal Investigator, Lead Physician, Reproductive Endocrinology and Infertility, Center for Advanced Reproductive Services
UConn Health