Poor In Vitro Fertilisation Outcomes in Genital Tuberculosis - Case Report

June 19, 2022 updated by: Kevin Dominique Tjandraprawira, Universitas Padjadjaran
This is a case series that highlights the challenges in instituting in vitro fertilisation (IVF) treatment amongs genital tuberculosis patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this case series, the investigators recruited patients undergoing IVF treatment previously diagnosed with TB between 01/01/2014 and 30/06/2021. Patients were recruited at the beginning of their IVF treatments. Total sampling was employed for this study.

Study Type

Observational

Enrollment (Actual)

7

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with confirmed genital tuberculosis previously diagnosed during laparoscopy to undergo in vitro fertilisation

Description

Inclusion Criteria:

  • patients with confirmed genital tuberculosis enrolling in in vitro fertilisation treatment

Exclusion Criteria:

  • patients not confirmed to having genital tuberculosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Live birth rate
Time Frame: 9 months of gestation
the number of live births divided by the number of patients recruited
9 months of gestation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate
Time Frame: 9 months of gestation
the number of clinical pregnancies divided by the number of patients recruited
9 months of gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Padjadjaran

Investigators

  • Principal Investigator: Kevin D Tjandraprawirra, M.D., M.Sc., Universitas Padjadjaran

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2014

Primary Completion (ACTUAL)

June 30, 2021

Study Completion (ACTUAL)

July 31, 2021

Study Registration Dates

First Submitted

June 12, 2022

First Submitted That Met QC Criteria

June 19, 2022

First Posted (ACTUAL)

June 22, 2022

Study Record Updates

Last Update Posted (ACTUAL)

June 22, 2022

Last Update Submitted That Met QC Criteria

June 19, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBGY-202206.01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

anonymised patient data may be shared upon a reasonable written request to the authors team.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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