Tuberculosis, Female GenitalNCT05428124
Poor In Vitro Fertilisation Outcomes in Genital Tuberculosis - Case Report
An observational study of Tuberculosis, Female Genital and Fertility Disorders, run by Universitas Padjadjaran.
Trial summary
This is a case series that highlights the challenges in instituting in vitro fertilisation (IVF) treatment amongs genital tuberculosis patients. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Tuberculosis, Female Genital, Fertility Disorders
- What is being tested?
- In vitro fertilisation
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 31 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women with confirmed genital tuberculosis previously diagnosed during laparoscopy to undergo in vitro fertilisation
Who may be able to join
- patients with confirmed genital tuberculosis enrolling in in vitro fertilisation treatment
Who cannot join
- patients not confirmed to having genital tuberculosis
About this study
This is a case series that highlights the challenges in instituting in vitro fertilisation (IVF) treatment amongs genital tuberculosis patients.
Read the 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.
- Conditions
- Tuberculosis, Female Genital, Fertility Disorders
- Being tested
- In vitro fertilisation
- Keywords
- In vitro fertilisation, Genital tuberculosis
- Medical subject headings
- Tuberculosis, Female Genital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In vitro fertilisationOther
Also called Assisted reproductive technology
In vitro fertilisation
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
the number of live births divided by the number of patients recruited
Measured: 9 months of gestation
Secondary outcomes (1)
Clinical pregnancy rate
the number of clinical pregnancies divided by the number of patients recruited
Measured: 9 months of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start1 Jan 2014
- Primary completion30 Jun 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tuberculosis, Female GenitalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Dominique Tjandraprawira, Universitas Padjadjaran
- Investigators
- Kevin D Tjandraprawirra, M.D., M.Sc., Principal investigator, Universitas Padjadjaran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428124
- Sponsor's protocol ID
- OBGY-202206.01
- Status last verified
- Jun 2022
- First submitted
- 12 Jun 2022
- Last updated
- 22 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: anonymised patient data may be shared upon a reasonable written request to the authors team.
Publications
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.
PubMed 26663993Djuwantono 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.
PubMed 29202851Dai 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.
PubMed 31847626
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Poor In Vitro Fertilisation Outcomes in Genital Tuberculosis - Case Report
- ClinicalTrials.gov ID
- NCT05428124
- Acronym / sponsor ID
- OBGY-202206.01
- Conditions
- Tuberculosis, Female Genital, Fertility Disorders
- Keywords
- In vitro fertilisation, Genital tuberculosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 22 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women with confirmed genital tuberculosis previously diagnosed during laparoscopy to undergo in vitro fertilisation
Key inclusion criteria (1 listed)
- patients with confirmed genital tuberculosis enrolling in in vitro fertilisation treatment
Key exclusion criteria (1 listed)
- patients not confirmed to having genital tuberculosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In vitro fertilisationAlso: Assisted reproductive technologyIn vitro fertilisation | Other | – |
Primary outcome
Live birth rate
Time frame: 9 months of gestation
the number of live births divided by the number of patients recruited
1 secondary outcome
Clinical pregnancy rate
Time frame: 9 months of gestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Background: PubMed 26663993Sharma 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.
- Results publication: PubMed 29202851Djuwantono 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.
- Results publication: PubMed 31847626Dai 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.
- Individual participant dataSharing planned: Undecided. anonymised patient data may be shared upon a reasonable written request to the authors team.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin D Tjandraprawirra, M.D., M.Sc. principal investigator
Universitas Padjadjaran
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, Female Genital and Fertility Disorders, run by Universitas Padjadjaran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate (time frame: 9 months of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05428124, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022; AzTrials last refreshed its copy on 7 Nov 2026.