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临床试验/NCT03153787
NCT03153787已完成不适用

Influence of Vaginal and Endometrial Microbiome on the Results of Assisted Reproduction Techniques and Probiotic Administration Effect: Controlled Before-and-after Study

Instituto Bernabeu2 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
69
试验地点
2
主要终点
Abortion rate

研究概览

简要总结

The objective of the present study to analyze the vaginal microbiome in patients who have not achieved gestation after oocyte donation treatment and after probiotic administration.

All patients will receive vaginal probiotic according to the standard regimen. Sample collection will be performed the embryo transfer day and on the day of the pregnancy test. Follow up of gestation will be carried out.

The analysis of the vaginal microbiome will be performed though massive genetic sequencing (determination of 16SRNA).

The study variables, among others, are vaginal microbiome pattern after probiotic administration, the gestation rate, and the abortion rate.

详细描述

This study will be performed after the observational study "Vaginal microbiome influence on the results of assisted reproduction techniques". The main goal of this previous study will be to identify patterns of vaginal and / or endometrial microbiome in relation to the gestation rate in women with implantation failure and / or repeat abortions who undergo an oocyte donation treatment. The vaginal and endometrial microbiome of women with (i) implantation failure, (ii) repeat abortions and (iii) control group without implantation failure or repeat abortions, will be analyzed before and after the embryo transfer.

Those women who do not achieve pregnancy will be eligible for the present study. The objective of the present study to analyze the vaginal microbiome in patients who have not achieved gestation after oocyte donation treatment and after probiotic administration.

All patients will receive vaginal probiotic according to the standard regimen: 1 tablet (via vaginal) for 5 days after menstruation during the same cycle of the next embryo transfer.

The vaginal sample will be analyzed after taking the probiotic. Sample collection will be performed the embryo transfer day and on the day of the pregnancy test. Follow up of gestation will be carried out.

Vaginal sample collection: obtention of vaginal fluid with vaginal swab by direct visualization. Direct visualization means having the patient in a lithotomy position, like a routine gynecological examination by visualization with a vaginal speculum.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
19 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Treated by oocyte donation.
  • Transfer of a single euploid embryo in the blastocyst phase.
  • <3 months prior without antibiotic treatment.
  • Women who have completed the previous observational study "Study of the influence of vaginal and endometrial microbiome on the results of assisted reproduction techniques".
  • Women who have not achieved gestation after treatment.
  • Signed informed consent form.

排除标准

  • Uterine malformations.
  • Not treated hydrosalpinx
  • Known factors of implantation failure and repetitive abortions, such as haematological disorders of hypercoagulability.

结局指标

主要结局

Abortion rate

时间窗: 45 weeks

Abortion rate (clinical and biochemical) after assisted reproduction technique

Change from Baseline Vaginal microbiome at 2 and 4 weeks

时间窗: 2 weeks and 4 weeks

Vaginal microbiome will be analyzed through massive genetic sequencing (determination of 16S RRNA) Before and after probiotic administration

Gestation rate

时间窗: 4 weeks

Gestation rate after assisted reproduction technique

次要结局

  • Live newborn rate(45 weeks)
  • Complications during gestation(45 weeks)

研究者

发起方
Instituto Bernabeu
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrea Bernabeu García

Principal Investigator

Instituto Bernabeu

研究点 (2)

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