Optimal Algorithmic Diagnosis of Genital TB among HIV-infected and Uninfected Infertile Women

Post Date: 
Clinical Sites: 
This study was terminated March 2020. It was funded by the Fogarty International Center at the U.S. National Institutes of Health.
There is a lack of a set protocol universally for diagnosis of genital TB, and for Indian hospitals, India's Revised National Tuberculosis Control Program (RNTCP) also does not give guidelines on diagnosis of Genital TB. Detection of Genital TB in the early stages has a good outcome with return of fertility and conception noted. In late stages, despite of TB diagnosis and treatment, pregnancy is rare and assisted reproductive techniques is the only method of having a biological child. This not only is very costly but also a burden on health system.
Due to availability of newer diagnostic tests, an expedited diagnosis of genital TB can be anticipated. Tests like TB-PCR and GeneXpert can be done on tissue samples and facilitate more timely initiation of TB treatment (referred to as antiKochs treatment or AKT). Many studies have tried to define genital TB cases as per microbiological, ultrasound (USG) and laparohysteroscopic criteria but a thorough definition of different types of cases i.e.: definite, probable or possible on the basis of clinical, USG, laboratory and laparohysteroscopy has not been published. We therefore propose to evaluate an algorithm whereby we will categorize infertility patients as having definite, probable, possible, or no TB diagnosis as a cause of infertility in HIV-infected and uninfected women.