A Retrospective study to evaluate the diagnostic capability of Gene Xpert MTB / RIF and Mycoreal polymerase chain reaction (PCR) techniques in the diagnosis of female genital tuberculosis

Gunasheela Surgical and Maternity Hospital1 个研究点分布在 1 个国家目标入组 3,400 人开始时间: 2019年2月12日最近更新: 2020年6月4日

试验速览

阶段: 不适用
状态: 已完成
发起方: Gunasheela Surgical and Maternity Hospital
入组人数: 3,400
试验地点: 1
主要终点: Sensitivity, specificity and diagnosis of genital tuberculosis

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Summary:

This is a Retrospective study to evaluate the diagnostic capability of gene expert and mycoreal PCR techniques in diagnosis of female genital tuberculosis considering culture as gold standard. Patients who attended the OPD between Jan 2013 and January 2017, satisfying the eligbility criteria, will be included in the study. Patients were subjected to endometrial pipelle sampling premenstrually (b/w Day 21- Day 24 of cycle) on OPD basis. Endometrial samples were tested for TB PCR and BACTEC culture. The Sensitivity, Specificity and Accuracy will be calculated.

研究设计

研究类型: Observational

入排标准

年龄范围: 20.00 Year(s) 至 40.00 Year(s)（—）
性别: Female

入选标准

•Unexplained infertility 2) Recurrent implantation failure 3) Recurrent pregnancy loss 4) Tubal factor 5) Uterine factors such as : Thin/pale endometrium, ashermans syndrome .

排除标准

•Ovulatory dysfunction 2) Endometriosis.
•Other uterine factors such as fibroid, polyp, adenomyosis, congenital uterine malformations.
•Male factor.

结局指标

主要结局

Sensitivity, specificity and diagnosis of genital tuberculosis

时间窗: Cross sectional study, only once sample will be collected from patients

次要结局

未报告次要终点

研究者

发起方

Gunasheela Surgical and Maternity Hospital

申办方类型

Private hospital/clinic

研究点 (1)

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