Prophylactic Antibiotics Prior to Embryo Transfer: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
The objective of this study is to determine the impact on clinical pregnancy rate of withholding routine prophylactic antibiotic therapy during IVF. The hypothesis is that withholding antibiotic prophylaxis will be non-inferior to routine administration. To test this hypothesis, the investigators will conduct a randomized controlled non inferiority trial. Additionally an exploratory study will be conducted among the first 30 patients undergoing their first cycle enrolled to evaluate the microbiome across the IVF cycle, in addition to the human virome
详细描述
Over 200,000 in vitro fertilization (IVF) cycles were initiated in the United States in 2015,1 allowing thousands of infertile couples to start families. Although most of the steps in IVF protocols are based on strong evidence, one, prophylactic antibiotic administration, is commonplace but not proven to produce benefit. This practice began in 1978 as a means to prevent bacterial contamination of the tip of the catheter used to transfer embryos into the uterus.2 Although subsequent studies showed that bacterial contamination of the transfer catheters had a negative impact on IVF cycle outcomes,3,4 a more recent, robust randomized controlled trial powered to detect catheter tip contamination rates noted a decrease in contamination with routine administration of amoxicillin-clavulanate but no difference in clinical pregnancy rate.5 Given the limited evidence for benefit and the true risk for subjecting patients to unnecessary treatments, one must determine whether prophylactic antibiotics actually improve the IVF outcome that matters most to couples: pregnancy.
The objective of this study is to determine the impact on clinical pregnancy rate of withholding routine prophylactic antibiotic therapy during IVF. The investigators hypothesis is that withholding antibiotic prophylaxis will be non-inferior to routine administration.
Additionally the investigators propose to conduct a smaller exploratory study in this population of the first 30 women enrolled (15 in each arm) to assess the vaginal microbiome and human virome as obtained by vaginal swab. Existing studies are limited and conflicting regarding influence of the microbiome on IVF cycle outcomes. This would be the first study to evaluate alterations in the vaginal microbiome across the IVF cycle in response to medications and supraphysiologic hormone levels, and the first to evaluate the human virome in this patient population.8 The investigators would examine differences within and between groups and assess for the potential impact and association clinical outcomes of those patients exposed to prophylactic azithromycin, and those who are not. Optimizing the vaginal microbiome could serve as a potential target for therapy to help increase IVF success rates in the future with the goal of a full term, live birth. Samples for male partners will be evaluated as well.
To test the hypothesis, the investigators will conduct a randomized controlled noninferiority trial and pursue the following specific aims:
Specific Aim 1: Determine the effect of withholding prophylactic antibiotic administration on clinical pregnancy rate (defined as a gestational sac, with fetal pole and cardiac activity, on ultrasound).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
The embryologists who assess embryo outcomes (as noted in the secondary outcomes) will be blinded to randomization.
入排标准
- 年龄范围
- 18 Years 至 43 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The female partner must be aged 18-43 years and going through a fresh IVF cycle
排除标准
- •Couples will be excluded from enrollment if they have any contraindication to antibiotic treatment, are not intending to undergo embryo transfer (fertility preservation patients and oocyte donors), require use of extended antibiotic coverage at time of egg retrieval, are already on antibiotics for any reason (e.g., upper respiratory infection), have a recent history of pelvic infection, or are planning on limited insemination (inseminating a limited number of the eggs retrieved) or are using donor sperm.
研究组 & 干预措施
Prophylactic antibiotics
Current standard of care in our practice for a fresh in vitro fertilization cycle is to administer one dose of 1 gram oral azithromycin on day one of the IVF cycle start to both the male and female partner. In cases of same-sex couples, only the female undergoing the embryo transfer receives prophylaxis. This will serve as our control arm entitled: prophylactic antibiotics.
No antibiotic prophylaxis.
Couples randomized to the no-antibiotic treatment group will not be prescribed oral antibiotic prophylaxis.
干预措施: Withholding antibiotic prophylaxis (Other)
结局指标
主要结局
Clinical pregnancy rate
时间窗: Our primary outcome measure will be obtained at 5-8 weeks gestational age following embryo transfer
Defined as a gestational sac, with fetal pole and cardiac activity, on ultrasound
次要结局
- Miscarriage rate(Prior to 20 weeks gestation in a previously established clinical pregnancy)
- Reproductive Tract Microbiome(Approximately 30 days from start of IVF cycle)
- Reproductive Tract Virome(Intraoperative (At the time of embryo transfer))
- Embryo development(Intraoperative (This outcome measure will be assessed from the time of egg retrieval to embryo transfer or embryo cryopreservation))
- Live birth(delivery)