Poor In Vitro Fertilisation Outcomes in Genital Tuberculo... | NCT05428124

Studies
Poor In Vitro Fertilisation Outcomes in Genital Tuberculosis - Case Report

NCT05428124

Sponsor

Universitas Padjadjaran

Status

Completed

Last Update Posted

Jun 22, 2022Actual

Enrollment

7Actual

Phase

Not provided

Conditions

Tuberculosis, Female Genital
Fertility Disorders

Interventions

In vitro fertilisation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2014Actual

Primary Completion Date

Jun 30, 2021Actual

Completion Date

Jul 31, 2021Actual

First Submitted Date

Jun 12, 2022

First Submission Date that Met QC Criteria

Jun 19, 2022

First Posted Date

Jun 22, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2022

Last Update Posted Date

Jun 22, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kevin Dominique Tjandraprawira, Junior Doctor in Obstetrics and Gynecology, Universitas PadjadjaranPrincipal Investigator

Lead Sponsor

Universitas PadjadjaranOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
In vitro fertilisation	Other	In vitro fertilisation		Assisted reproductive technology

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with confirmed genital tuberculosis enrolling in in vitro fertilisation treatment

Exclusion Criteria:

patients not confirmed to having genital tuberculosis

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kevin D Tjandraprawirra, M.D., M.Sc.	Universitas Padjadjaran	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26663993	Background	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.
29202851	Result	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.

ID	Term
D014401	Tuberculosis, Urogenital
D000092225	Tuberculosis, Extrapulmonary
D014376	Tuberculosis
D009164	Mycobacterium Infections

ID	Term
D005307	Fertilization in Vitro
D027724	Reproductive Techniques, Assisted

ID	Term
D012099	Reproductive Techniques
D013812	Therapeutics
D008919	Investigative Techniques