NCT05428124

Brief Summary

This is a case series that highlights the challenges in instituting in vitro fertilisation (IVF) treatment amongs genital tuberculosis patients.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 22, 2022

Completed
Last Updated

June 22, 2022

Status Verified

June 1, 2022

Enrollment Period

7.5 years

First QC Date

June 12, 2022

Last Update Submit

June 19, 2022

Conditions

Tuberculosis, Female GenitalFertility Disorders

Keywords

In vitro fertilisationGenital tuberculosis

Outcome Measures

Primary Outcomes (1)

  • Live birth rate

    the number of live births divided by the number of patients recruited

    9 months of gestation

Secondary Outcomes (1)

  • Clinical pregnancy rate

    9 months of gestation

Interventions

In vitro fertilisationOTHER

In vitro fertilisation

Also known as: Assisted reproductive technology

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • patients not confirmed to having genital tuberculosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Sharma JB. Current Diagnosis and Management of Female Genital Tuberculosis. J Obstet Gynaecol India. 2015 Dec;65(6):362-71. doi: 10.1007/s13224-015-0780-z. Epub 2015 Oct 7.

    PMID: 26663993BACKGROUND

  • Djuwantono T, Permadi W, Septiani L, Faried A, Halim D, Parwati I. Female genital tuberculosis and infertility: serial cases report in Bandung, Indonesia and literature review. BMC Res Notes. 2017 Dec 4;10(1):683. doi: 10.1186/s13104-017-3057-z.

    PMID: 29202851RESULT

  • Dai W, Ma L, Cao Y, Wu D, Yu T, Zhai J. In vitro fertilization outcome in women with endometrial tuberculosis and tubal tuberculosis. Gynecol Endocrinol. 2020 Sep;36(9):819-823. doi: 10.1080/09513590.2019.1702639. Epub 2019 Dec 17.

    PMID: 31847626RESULT

MeSH Terms

Conditions

Tuberculosis, Female Genital

Interventions

Fertilization in VitroReproductive Techniques, Assisted

Condition Hierarchy (Ancestors)

Tuberculosis, UrogenitalTuberculosis, ExtrapulmonaryTuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive TechniquesTherapeuticsInvestigative Techniques

Study Officials

  • Kevin D Tjandraprawirra, M.D., M.Sc.

    Universitas Padjadjaran

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Junior Doctor in Obstetrics and Gynecology

Study Record Dates

First Submitted

June 12, 2022

First Posted

June 22, 2022

Study Start

January 1, 2014

Primary Completion

June 30, 2021

Study Completion

July 31, 2021

Last Updated

June 22, 2022

Record last verified: 2022-06