Infertility, FemaleTB-PRIMENCT05311423
The Prevalence and Reproductive Outcome of Infertile Women With Genital Tuberculosis
An observational study of Infertility, Female and Genital Tuberculoses, Female, run by Huashan Hospital at 1 site in China.
Trial summary
Female genital tuberculosis infection (FGTB) is an important cause of female infertility in TB-endemic areas. The pregnancy rate of assisted reproductive treatment (ART) in the infertile women with FGTB is still unsatisfied even after receiving standard anti-tuberculosis treatment. Read more about this study
- Who is it for?
- Ages 20 to 43 years, women only
- Conditions the study is for
- Infertility, Female, Genital Tuberculoses, Female
- What is being tested?
- QuantiFERON-TB test & endometrial pathology & endometrial tissue GeneXpert Ultra
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 1 Aug 2023
- How long will I take part?
- 18 Months
- 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 20 to 43 years
- Women only
- No healthy volunteers
- Adult
Study population: Infertile female patients with high risk factors for tuberculosis infection who intend to undergo assisted reproduction
Who may be able to join
- 1) Female, aged ≥20 years and <43 years old;
- 2) In line with conventional assisted reproduction indications;
- 3) Meet any of the following:
- with tuberculosis infection history;
- with a history of close contact to tuberculosis patients;
- exact positive IGRA results in the past or chest imaging indicated a past history of pulmonary tuberculosis;
Show all 9Show fewer
- suspected symptoms of tuberculosis, including fever, night sweats, fatigue, cough and sputum;
- suspected symptoms of genital tuberculosis, including lower abdominal pain, abnormal menstruation, fallopian tube stenosis, obstruction, thickening, beading changes, uterine cavity adhesions, deformation, pelvic adhesions, etc.;
- 4) Voluntarily join the study and sign the informed consent
Who cannot join
- 1) Co-infection with HIV;
- 2) Chromosomal abnormalities;
- 3) suspected genital tuberculosis infection symptoms (participants meet inclusion criteria 3)e in Inclusion Criteria) known to be caused only by factors part from tuberculosis, such as endocrine factors, history of ectopic pregnancy, history of uterine curettage, chronic pelvic inflammatory disease, endometriosis, malignant tumors, etc.;
- 4) There are other serious physical or mental illnesses that are not suitable for selection;
- 5) Participate in other clinical studies that would affect this study at the same time.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai First Maternity and Infant Hospital
Shanghai, Shanghai Municipality, 200051
Xiaoming Teng, Dr., 021-54035206, tengxiaoming@51mch.com
Xiaoming Teng, Dr.
About this study
Official title: The Prevalence of Genital Tuberculosis and the Impact on Reproductive Outcomes in Infertile Women: a National Multicenter Prospective Cohort Study
Female genital tuberculosis infection (FGTB) is an important cause of female infertility in TB-endemic areas. The pregnancy rate of assisted reproductive treatment (ART) in the infertile women with FGTB is still unsatisfied even after receiving standard anti-tuberculosis treatment. Moreover, recent years have witnessed an alarming increase in reports of FGTB-related maternal and neonatal complications after fertility treatments. These underscore that timely detection and treatment of FGTB before ART hold benefit for the mother and child.
Read the detailed description
This project aims to recruit infertile female with high risk of tuberculosis infecton who need assisted reproductive treatment in multiple reproductive centers. The infertility-related medical history and laboratory examination results were recorded according to clinical routine, and other essential information such as tuberculosis symptoms, tuberculosis-related history and other health conditions were also recorded, and the pregnancy outcomes of these patients were followed up.
According to the results of clinical screening, they were divided into four cohorts: non-tuberculosis (non-TB) group, latent tuberculosis infection (LTBI) group, subclinical genital tuberculosis infection (SGTB) group and female genital tuberculosis infection (FGTB) group.
Non-TB group: QuantiFERON-TB test (QFT) negative, continue assisted reproductive treatment; LTBI group: QFT positive. Excluded active pulmonary tuberculosis, patients have negative endometrial histopathology, acid-fast bacilli (AFB) microscopy, Mycobacterium tuberculosis (Mtb) culture, or GeneXpert MTB/RIF Ultra test results. Then assisted reproductive treatment can be continued, but follow-up for tuberculosis-related symptoms is required; SGTB group: QFT positive. Excluded active pulmonary tuberculosis, patients have negative endometrial histopathology, AFB microscopy, Mtb culture, but GeneXpert MTB/RIF Ultra positive test results. They are recommended to receive 6-month first-line standard anti-tuberculosis treatment (ATT) regimen; FGTB group: QFT positive. Excluded active pulmonary tuberculosis, regardless of GeneXpert MTB/RIF Ultra results, at least one of these test results, including endometrial histopathologiy, AFB microscopy, Mtb culture is positive, they will receive 6-month ATT.
Patients diagnosed with SGTB and FGTB will receive 6-month first-line standard ATT before ART, and follow up their anti-tuberculosis drug-related adverse reactions (TB-ARs) according to clinical routine to prevent the occurrence of grade 3-4 adverse drug reactions.
All cohorts will be followed up for pregnancy outcomes after entering the assisted reproduction cycle, and the pregnancy outcomes of all subjects after the first assisted reproduction after enrollment were recorded. Follow-up nodes included the 2nd, 4th, 10th weeks and 37th weeks of gestation. Follow-up content includes pregnancy status. Follow-up subjects will be terminated when adverse pregnancy outcomes such as ectopic pregnancy and miscarriage occurred; follow-up of pregnant participants will be extended to 2 weeks postpartum. Participants from the SGTB or FGTB group achieve pregnant naturally after drug withdrawal, the follow-up of the natural pregnancy outcome will be started as well.
- Conditions
- Infertility, Female, Genital Tuberculoses, Female
- Being tested
- QuantiFERON-TB test & endometrial pathology & endometrial tissue GeneXpert Ultra
- Medical subject headings
- Infertility, Female, Tuberculosis, Female Genital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuantiFERON-TB test & endometrial pathology & endometrial tissue GeneXpert UltraDiagnostic test
Endometrial biopsy is required to diagnose LTBI, SGTB and FGTB, which is an invasive operation and increases patients' economic burden. A screening method has been established that uses the interferon gamma release test as the primary screening test, and those who are positive undergo endometrial biopsy. Therefore, this project will use QFT to screen participants with Mtb infection, and further endometrium biopsy will be performed for QFT positive patients to diagnose LTBI, FGTB and SGTB. For participants with negative results for all diagnostic tests but QFT (defined as LTBI), close follow-up is necessary according to WHO guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Non-TB Group | QuantiFERON-TB test (QFT) negative, continue assisted reproductive treatment Receives: Diagnostic Test: QuantiFERON-TB test & endometrial pathology & endometrial tissue GeneXpert Ultra | |
| Latent tuberculosis infection Group | QFT positive. Excluded active pulmonary tuberculosis, patients have negative endometrial histopathology, acid-fast bacilli (AFB) microscopy, Mycobacterium tuberculosis (Mtb) culture, or GeneXpert MTB/RIF Ultra test results. Then assisted reproductive treatment can be continued, but follow-up for tuberculosis-related symptoms is required Receives: Diagnostic Test: QuantiFERON-TB test & endometrial pathology & endometrial tissue GeneXpert Ultra | |
| Subclinical genital tuberculosis Group | QFT positive. Excluded active pulmonary tuberculosis, patients have negative endometrial histopathology, AFB microscopy, Mtb culture, but GeneXpert MTB/RIF Ultra positive test results. They are recommended to receive 6-month first-line standard anti-tuberculosis treatment (ATT) regimen Receives: Diagnostic Test: QuantiFERON-TB test & endometrial pathology & endometrial tissue GeneXpert Ultra | |
| Female genital tuberculosis Group | QFT positive. Excluded active pulmonary tuberculosis, regardless of GeneXpert MTB/RIF Ultra results, at least one of these test results, including endometrial histopathologiy, AFB microscopy, Mtb culture is positive, they will receive 6-month ATT Receives: Diagnostic Test: QuantiFERON-TB test & endometrial pathology & endometrial tissue GeneXpert Ultra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate of ART
the number of participants with gestational sacs seen by ultrasound examination 4-6 weeks after transplantation/the number of embryo transfer cycles in this group
Measured: 2 years
Continued pregnancy rate of ART
the number of patients whose pregnancy was confirmed by repeat ultrasonography at 10th week of gestation/the number of embryo transfer cycles in this group
Measured: 2 years
Prevalence of SGTB among infertile women
the number of SGTB participants/the total number of this project
Measured: 6 months
Secondary outcomes (12)
Prevalence of FGTB/LTBI among infertile women
the number of each group/the total number of this project
Measured: 2 years
Abortion rate
number of abortions/number of clinical pregnancy in non-TB or LTBI or SGTB or FGTB group
Measured: 2 years
Ectopic pregnancy rate
number of ectopic pregnancy/number of clinical pregnancy in non-TB or LTBI or SGTB or FGTB group
Measured: 2 years
Preterm birth rate
the number of premature births/the number of clinical pregnancy in non-TB or LTBI or SGTB or FGTB group
Measured: 2 years
Live birth rate
the number of live births/the number of clinical pregnancy in non-TB or LTBI or SGTB or FGTB group
Measured: 2 years
Maternal mortality rate
the number of maternal mortality/the number of clinical pregnancy in non-TB or LTBI or SGTB or FGTB group
Measured: 2 years
Neonatal mortality rate
the number of neonatal mortality/the number of clinical pregnancy in non-TB or LTBI or SGTB or FGTB group
Measured: 2 years
Spontaneous pregnancy rate
number of Spontaneous pregnancy/number of subjects completed ATT in FGTB/SGTB group
Measured: 2 years
The incidence of grade 3-4 adverse events
the number of patients with grade 3-4 adverse events during anti-tuberculosis treatment / the total number of in FGTB/SGTB group
Measured: 2 years
The rate of drug discontinuation due to adverse drug reactions
the number of patients who discontinued in anti-tuberculosis treatment due to adverse drug reactions / the total number of patients with adverse reactions in FGTB/SGTB group
Measured: 2 years
Treatment completion rate
number of patients who completed anti-tuberculosis treatment / total number of patients in this group × 100%
Measured: 2 years
Incidence of active tuberculosis of LTBI group during 1 year after enrollment
the number of subjects who develop to active tuberculosis during 1 year after enrollment/the number of subjects of LTBI group
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start1 Dec 2021
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai First Maternity and Infant Hospital, General Hospital of Ningxia Medical University, Tang-Du Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First Affiliated Hospital of Zhengzhou University, The 924th Hospital of Joint Logistics Support Force of Chinese People's Liberation, Shenzhen Zhongshan Urology Hospita, Northwest Women's and Children's Hospital, Xi'an, Shaanxi, Jiangxi Maternal and Child Health Hospital, The First People's Hospital of Yunnan, Tongji Hospital, The Second Hospital of Hebei Medical University, First Affiliated Hospital of Wenzhou Medical University
- Responsible party
- Principal investigator, Wen-hong Zhang, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311423
- Sponsor's protocol ID
- KY2021-840
- Acronym
- TB-PRIME
- Status last verified
- Mar 2022
- First submitted
- 21 Jan 2022
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Genital Tuberculosis and the Impact on Reproductive Outcomes in Infertile Women: a National Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05311423
- Acronym / sponsor ID
- TB-PRIME / KY2021-840
- Conditions
- Infertility, Female, Genital Tuberculoses, Female
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Shanghai First Maternity and Infant Hospital, General Hospital of Ningxia Medical University, Tang-Du Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First Affiliated Hospital of Zhengzhou University, The 924th Hospital of Joint Logistics Support Force of Chinese People's Liberation, Shenzhen Zhongshan Urology Hospita, Northwest Women's and Children's Hospital, Xi'an, Shaanxi, Jiangxi Maternal and Child Health Hospital, The First People's Hospital of Yunnan, Tongji Hospital, The Second Hospital of Hebei Medical University, First Affiliated Hospital of Wenzhou Medical University
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 5 Apr 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.
Female genital tuberculosis infection (FGTB) is an important cause of female infertility in TB-endemic areas. The pregnancy rate of assisted reproductive treatment (ART) in the infertile women with FGTB is still unsatisfied even after receiving standard anti-tuberculosis treatment. Moreover, recent years have witnessed an alarming increase in reports of FGTB-related maternal and neonatal complications after fertility treatments. These underscore that timely detection and treatment of FGTB before ART hold benefit for the mother and child.
Detailed description
This project aims to recruit infertile female with high risk of tuberculosis infecton who need assisted reproductive treatment in multiple reproductive centers. The infertility-related medical history and laboratory examination results were recorded according to clinical routine, and other essential information such as tuberculosis symptoms, tuberculosis-related history and other health conditions were also recorded, and the pregnancy outcomes of these patients were followed up.
According to the results of clinical screening, they were divided into four cohorts: non-tuberculosis (non-TB) group, latent tuberculosis infection (LTBI) group, subclinical genital tuberculosis infection (SGTB) group and female genital tuberculosis infection (FGTB) group.
Non-TB group: QuantiFERON-TB test (QFT) negative, continue assisted reproductive treatment; LTBI group: QFT positive. Excluded active pulmonary tuberculosis, patients have negative endometrial histopathology, acid-fast bacilli (AFB) microscopy, Mycobacterium tuberculosis (Mtb) culture, or GeneXpert MTB/RIF Ultra test results. Then assisted reproductive treatment can be continued, but follow-up for tuberculosis-related symptoms is required; SGTB group: QFT positive. Excluded active pulmonary tuberculosis, patients have negative endometrial histopathology, AFB microscopy, Mtb culture, but GeneXpert MTB/RIF Ultra positive test results. They are recommended to receive 6-month first-line standard anti-tuberculosis treatment (ATT) regimen; FGTB group: QFT positive. Excluded active pulmonary tuberculosis, regardless of GeneXpert MTB/RIF Ultra results, at least one of these test results, including endometrial histopathologiy, AFB microscopy, Mtb culture is positive, they will receive 6-month ATT.
Patients diagnosed with SGTB and FGTB will receive 6-month first-line standard ATT before ART, and follow up their anti-tuberculosis drug-related adverse reactions (TB-ARs) according to clinical routine to prevent the occurrence of grade 3-4 adverse drug reactions.
All cohorts will be followed up for pregnancy outcomes after entering the assisted reproduction cycle, and the pregnancy outcomes of all subjects after the first assisted reproduction after enrollment were recorded. Follow-up nodes included the 2nd, 4th, 10th weeks and 37th weeks of gestation. Follow-up content includes pregnancy status. Follow-up subjects will be terminated when adverse pregnancy outcomes such as ectopic pregnancy and miscarriage occurred; follow-up of pregnant participants will be extended to 2 weeks postpartum. Participants from the SGTB or FGTB group achieve pregnant naturally after drug withdrawal, the follow-up of the natural pregnancy outcome will be started as well.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-TB Group | – | Diagnostic Test: QuantiFERON-TB test & endometrial pathology & endometrial tissue GeneXpert UltraQuantiFERON-TB test (QFT) negative, continue assisted reproductive treatment |
| Latent tuberculosis infection Group | – | Diagnostic Test: QuantiFERON-TB test & endometrial pathology & endometrial tissue GeneXpert UltraQFT positive. Excluded active pulmonary tuberculosis, patients have negative endometrial histopathology, acid-fast bacilli (AFB) microscopy, Mycobacterium tuberculosis (Mtb) culture, or GeneXpert MTB/RIF Ultra test results. Then assisted reproductive treatment can be continued, but follow-up for tuberculosis-related symptoms is required |
| Subclinical genital tuberculosis Group | – | Diagnostic Test: QuantiFERON-TB test & endometrial pathology & endometrial tissue GeneXpert UltraQFT positive. Excluded active pulmonary tuberculosis, patients have negative endometrial histopathology, AFB microscopy, Mtb culture, but GeneXpert MTB/RIF Ultra positive test results. They are recommended to receive 6-month first-line standard anti-tuberculosis treatment (ATT) regimen |
| Female genital tuberculosis Group | – | Diagnostic Test: QuantiFERON-TB test & endometrial pathology & endometrial tissue GeneXpert UltraQFT positive. Excluded active pulmonary tuberculosis, regardless of GeneXpert MTB/RIF Ultra results, at least one of these test results, including endometrial histopathologiy, AFB microscopy, Mtb culture is positive, they will receive 6-month ATT |
Who may qualify
- Ages
- 20 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Infertile female patients with high risk factors for tuberculosis infection who intend to undergo assisted reproduction
Key inclusion criteria (9 listed)
- 1) Female, aged ≥20 years and <43 years old;
- 2) In line with conventional assisted reproduction indications;
- 3) Meet any of the following:
- 4) Voluntarily join the study and sign the informed consent
Key exclusion criteria (5 listed)
- 1) Co-infection with HIV;
- 2) Chromosomal abnormalities;
- 3) suspected genital tuberculosis infection symptoms (participants meet inclusion criteria 3)e in Inclusion Criteria) known to be caused only by factors part from tuberculosis, such as endocrine factors, history of ectopic pregnancy, history of uterine curettage, chronic pelvic inflammatory disease, endometriosis, malignant tumors, etc.;
- 4) There are other serious physical or mental illnesses that are not suitable for selection;
- 5) Participate in other clinical studies that would affect this study at the same time.
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 |
|---|---|---|
| QuantiFERON-TB test & endometrial pathology & endometrial tissue GeneXpert UltraEndometrial biopsy is required to diagnose LTBI, SGTB and FGTB, which is an invasive operation and increases patients' economic burden. A screening method has been established that uses the interferon gamma release test as the primary screening test, and those who are positive undergo endometrial biopsy. Therefore, this project will use QFT to screen participants with Mtb infection, and further endometrium biopsy will be performed for QFT positive patients to diagnose LTBI, FGTB and SGTB. For participants with negative results for all diagnostic tests but QFT (defined as LTBI), close follow-up is necessary according to WHO guidelines. | Diagnostic test | Female genital tuberculosis Group, Latent tuberculosis infection Group, Non-TB Group, Subclinical genital tuberculosis Group |
Primary outcome
Clinical pregnancy rate of ART
Time frame: 2 years
the number of participants with gestational sacs seen by ultrasound examination 4-6 weeks after transplantation/the number of embryo transfer cycles in this group
Continued pregnancy rate of ART
Time frame: 2 years
the number of patients whose pregnancy was confirmed by repeat ultrasonography at 10th week of gestation/the number of embryo transfer cycles in this group
Prevalence of SGTB among infertile women
Time frame: 6 months
the number of SGTB participants/the total number of this project
12 secondary outcomes
Prevalence of FGTB/LTBI among infertile women
Time frame: 2 years
Abortion rate
Time frame: 2 years
Ectopic pregnancy rate
Time frame: 2 years
Preterm birth rate
Time frame: 2 years
Live birth rate
Time frame: 2 years
Maternal mortality rate
Time frame: 2 years
Neonatal mortality rate
Time frame: 2 years
Spontaneous pregnancy rate
Time frame: 2 years
The incidence of grade 3-4 adverse events
Time frame: 2 years
The rate of drug discontinuation due to adverse drug reactions
Time frame: 2 years
Treatment completion rate
Time frame: 2 years
Incidence of active tuberculosis of LTBI group during 1 year after enrollment
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female and Genital Tuberculoses, Female, run by Huashan Hospital at 1 site in China.
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 9 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qiaoling Ruan, Dr. (021-52887946, qlruan07@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate of ART (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2022.