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临床试验/NCT03637777
NCT03637777已完成不适用

Characterization of the Reproductive Tract and Gastrointestinal Tract Microbiome and Its Association With Pregnancy Outcomes Following Frozen Embryo Transfer

Reproductive Medicine Associates of New Jersey1 个研究点 分布在 1 个国家目标入组 332 人开始时间: 2018年8月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
332
试验地点
1
主要终点
Live birth

研究概览

简要总结

Patients and partners undergoing an autologous IVF cycle will be recruited to participate in this prospective observational study investigating the microbiome and its association with IVF pregnancy outcomes. During the the controlled ovarian hyperstimulation cycle as well as the frozen embryo transfer cycle, a number of specimens will be collected for next generation sequencing of 16S rRNA to evaluate the microbiome profile of the reproductive and gastrointestinal tracts. Data on pregnancy outcomes will be collected prospectively and evaluated to identify associations with the microbiome.

详细描述

PURPOSE OF STUDY

To characterize the microbiome of the female reproductive tract and gastrointestinal tract as well as the male reproductive tract in patients and partners undergoing IVF and determine if there are any associations with pregnancy outcomes.

The Clinical Problem

The microbiome of the reproductive tract and its association with reproductive outcomes is a topic of evolving interest. Alterations in the vaginal microbiome have been linked to obstetric complications including miscarriage and preterm birth. More recent data have emerged linking the vaginal microbiome to assisted reproductive technology (ART) outcomes. A prospective observational study consisting of 30 patients who had swabs collected at various time points during the in vitro fertilization-embryo transfer (IVF-ET) cycle for sequencing of the 16S ribosomal RNA gene concluded that the species diversity of the vaginal microbiome distinguished women who had a live birth from those who did not with increased diversity being associated with poorer outcomes; however, the patient population was heterogeneous and small.

Limited information is available regarding the microbiome of the upper genital tract and its association with reproductive outcomes, particularly in the setting of ART. Studies done solely for the purpose of characterizing the upper genital tract microbiome have relied on hysterectomy specimens to assess colonization, thus precluding evaluation of any association with reproductive outcomes. Perhaps the first study to investigate the association between the microbiome of the upper reproductive tract and ART outcomes utilized culture-based technology on embryo transfer catheter tips. However, this study utilized culture-based technology, with only four major bacteria were reported. Subsequent studies have highlighted the limitations of culture-based technology, namely that it is reliant upon successful culture, often resulting in an underestimate of the diversity of organisms.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients initiating an autologous IVF cycle
  • Patient age 18-45; partner age 18-60
  • Partner planning to provide fresh semen sample on day of oocyte retrieval
  • Patients planning to undergo preimplantation genetic screening (PGS) of embryos with single embryo transfer (SET)

排除标准

  • > 1 prior failed IVF cycle
  • Third party reproduction
  • Planning to bank embryos
  • Partner using cryo sperm or surgical sperm on day of retrieval
  • Male or female partner antibiotic use within 1 month of IVF cycle start
  • Mullerian anomalies, excluding arcuate uterus
  • Submucosal fibroids
  • History of uterine surgery, excluding polypectomy, D&C, and Cesarean section
  • Communicating hydrosalpinx without plans for surgical correction prior to embryo transfer

结局指标

主要结局

Live birth

时间窗: 10 months

Delivery of a live infant

次要结局

  • Ongoing pregnancy(2 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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