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临床试验/NCT02042352
NCT02042352已完成不适用

PNA FISH, PCR and Gram Staining for Detection of Bacterial Vaginosis - a Comparative Clinical Study in a Danish IVF Setting

Regionshospitalet Viborg, Skive1 个研究点 分布在 1 个国家目标入组 195 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
195
试验地点
1
主要终点
Cost-benefit analysis of the molecular tests to conventional Gram staining

研究概览

简要总结

The primary aim of the present study is to investigate the vaginal microbiota of infertile women with two novel molecular based diagnostic tests for Bacterial Vaginosis, a PNA FISH and a PCR method supported with conventional Gram staining.

We hypothesize that the molecular based tests will prove more efficient than conventional Gram staining and that they have a place in future IVF diagnostics.

详细描述

Our first aim is to investigate the prevalence of altered vaginal microbiotas among women seeking fertility treatment in Denmark. Secondly we want to establish whether there are correlations between altered vaginal microbiotas and self-measurements of both the vaginal pH performed with the Saling pH glove™ and a self-collected swab with Copan Eswab™ because these would be useful for an easy-access longitudinal screening option. Finally, the third aim was to explore how the species composition of vaginal microbiotas measured by a multiplex qPCR assay was reflected in Nugent scores.

A possible 4th aim is to identify patterns in the relative abundances of different species with 16sRNA primers among fertile women compared with infertile women because these differences could be indicative of a vaginal microbiota associated with bad fertility outcome.

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 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Seeking IVF treatment

排除标准

  • Bleeding and sexual intercourse within 24h

结局指标

主要结局

Cost-benefit analysis of the molecular tests to conventional Gram staining

时间窗: 1 year

次要结局

未报告次要终点

研究者

发起方
Regionshospitalet Viborg, Skive
申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Humaidan

Professor

Regionshospitalet Viborg, Skive

研究点 (1)

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