Infertility, FemalePhase 3SCRIPT-LGTBNCT04528277
Short Course Rifapentine and Isoniazid for the Preventive Treatment for Latent Genital Tuberculosis
A Phase 3 study testing rifapentine plus isoniazid in people with Infertility, Female and Recurrent Implantation Failure, run by Huashan Hospital at 1 site in China.
Trial summary
The purpose of this study is to assess the efficacy, safety and tolerability of the 1-month regimen of three times weekly rifapentine plus isoniazid in improving fertility outcome in recurrent implantation failure (RIF) patients with latent genital tuberculosis (LGTB), compared to no treatment and non-LGTB patients. Read more about this study
- Who is it for?
- Ages 25 to 40 years, women only
- Conditions the study is for
- Infertility, Female, Recurrent Implantation Failure, Genital Tuberculoses, Female
- What is being tested?
- rifapentine plus isoniazid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,050 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 1 Sep 2022
- Phase
- Phase 3
- 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 25 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 25-40 years old
- Infertile women failed to achieve clinical pregnancy after 4 good quality embryo transfers, with at least 3 fresh or frozen IVF cycles
- Intended to undergo IVF/ICSI
- Ultrasonography or hysterosalpingogram showed a normal uterus cavity, and the thickness of the endometrium was ≥8mm before implantation during last IVF/ICSI cycle
- Patients who voluntarily signed the informed consent and agreed to be followed up as required by the study protocol
Who cannot join
- Use of donor eggs/sperm
- An abnormal uterine cavity shown on hysterosalpingogram or hysteroscopy
- Proven tubal infertility
- Proven preimplantation genetic abnormality
- Proven active tuberculosis
- Treated for active tuberculosis or used preventive treatment for LTBI within 2 years
Show all 12Show fewer
- Being allergic or intolerant of any study drug
- HIV antibody positive and AIDS patients
- Patients with impaired liver function: hepatic encephalopathy, ascites; total bilirubin is more than 2 times higher than the upper limit of normal; alanine transaminase (ALT) or aspartate aminotransferase (AST) is more than 5 times the upper limit of normal
- Patients with diabetes mellitus
- Critically ill patients, and according to the judgment of the research physician, it is impossible to survive for more than 16 weeks
- Currently participating in another drug clinical trial
Trial locations and contacts
1 site in 1 country.
China1 site
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: Role of Short Course Rifapentine and Isoniazid for the Preventive Treatment for Latent Genital Tuberculosis in Women With Recurrent Implantation Failure: A Prospective Interventional Cohort Study
The purpose of this study is to assess the efficacy, safety and tolerability of the 1-month regimen of three times weekly rifapentine plus isoniazid in improving fertility outcome in recurrent implantation failure (RIF) patients with latent genital tuberculosis (LGTB), compared to no treatment and non-LGTB patients.
Read the detailed description
The prevalence of latent genital tuberculosis (LGTB) is relatively high in women with infertility and recurrent pregnancy loss. Whether preventive treatment of latent tuberculosis infection (LTBI) can improve the fertility outcome in women with recurrent implantation failure (RIF) remains to be explored.
This is a prospective interventional cohort study.The main purpose of this study is to compare the fertility outcome between 1-month regimen of three times weekly rifapentine plus isoniazid and no treatment in RIF patients with LGTB and RIF patients without LGTB. The study will also assess the safety and tolerability and the efficacy of the preventive treatment regimen in prevention of the incidence of active female genital tuberculosis (FGTB).
A total of 1050 participants will be recruited for screening of LGTB. The endometrial tuberculosis (TB) polymerase chain reaction (PCR) test will be employed for the diagnosis of LGTB. Eligible participants with negative TB PCR results will be assigned to the non-LGTB group, while those with positive TB PCR results will be assigned to the LGTB group. The LGTB group will be further assigned, according to their will to receive preventive treatment of tuberculosis, to one of the following groups: the LGTB treatment group and the LGTB no treatment group.
The LGTB treatment group will receive the 1-month regimen of three times weekly rifapentine plus isoniazid, and the in vitro fertilization (IVF)/ intra cytoplasmic sperm injection (ICSI) cycle can be started after 1 month post the completion of the treatment regimen. Adverse events and side effects will be monitored at a 2-week interval during the preventive treatment and followed up once more at 4 weeks post the end of treatment. The LGTB no treatment group and the non-LGTB group will start the IVF/ICSI cycle directly after enrollment without taking any medication related to preventive treatment of tuberculosis.
Eligible participants will be followed up until the end of an IVF/ ICSI cycle or pregnancy. Fertility outcomes of both groups will be recorded and compared. Secondary outcomes, including the incidence of adverse events, the adhesion of treatment and the incidence of LGTB and FGTB, ovarian reserve, embryo quality, history of infertility and tuberculosis will also be recorded and compared.
- Conditions
- Infertility, Female, Recurrent Implantation Failure, Genital Tuberculoses, Female, Genital Tuberculosis, Latent
- Being tested
- rifapentine plus isoniazid
- 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.
rifapentine plus isoniazidDrug
receive the 1-month regimen of three times weekly rifapentine (450mg po) plus isoniazid (400mg po)
| Study group | Role | What they receive |
|---|---|---|
| LGTB treatment group | Experimental | The LGTB treatment group will receive the 1-month regimen of three times weekly rifapentine (150mg per capsule, 450mg po tiw) plus isoniazid (100mg per tablet, 400mg po tiw). Receives: Drug: rifapentine plus isoniazid |
| LGTB no treatment group | No intervention | The LGTB no treatment group will not take any medication related to preventive treatment of tuberculosis. |
| non-LGTB group | No intervention | The non-LGTB group will not take any medication related to preventive treatment of tuberculosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rates
Clinical pregnancy was defined as the presence of at least one gestational sac on ultrasound at 6 weeks.
Measured: 6 weeks after completion of an IVF/ICSI cycle
Ongoing Pregnancy Rate
Ongoing pregnancy was the presence of at least one foetus with heart pulsation on ultrasound beyond 10 weeks.
Measured: 10 weeks after completion of an IVF/ICSI cycle
Miscarriage rate
The number of miscarriages before 22 weeks divided by the number of participants with positive pregnancy test.
Measured: 22 weeks after completion of an IVF/ICSI cycle
Secondary outcomes (7)
Implantation rate
The number of gestational sacs seen on scanning divided by the number of embryos replaced.
Measured: 6 weeks after completion of an IVF/ICSI cycle
Incidence of LGTB
The number of participants diagnosed with LGTB devided by the number of participants screened for LGTB.
Measured: 4 weeks after enrollment
Incidence of FGTB
The number of participants developed FGTB during treatment or follow-up devided by the number of participants in the LGTB treatment group.
Measured: 2 years
Incidence of grade 3 or greater adverse events
The number of participants reported grade 3 or greater adverse events during treatment or follow-up devided by the number of participants in the LGTB treatment group.
Measured: 20 weeks after preventive treatment initiated
Completion rate of preventive treatment
11 or 12 doses of the 1-month preventive treatment regimen of three times weekly rifapentine plus isoniazid taken within 16 weeks after treatment initiated will be regarded as completion of preventive treatment. The number of participants completed treatment devided by the number of participants initiated the preventive treatment.
Measured: 20 weeks after preventive treatment initiated
Discontinuation of treatment
The number of participants discontinued treatment devided by the number of participants in the LGTB treatment group.
Measured: 20 weeks after preventive treatment initiated
Discontinuation of treatment due to side effect of study drugs
The number of participants discontinued treatment due to side effect of study drugs devided by the number of participants in the LGTB treatment group.
Measured: 20 weeks after preventive treatment initiated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai First Maternity and Infant Hospital
- Responsible party
- Principal investigator, Wen-hong Zhang, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528277
- Sponsor's protocol ID
- KS20232
- Acronym
- SCRIPT-LGTB
- Status last verified
- Aug 2020
- First submitted
- 22 Aug 2020
- Last updated
- 27 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grace GA, Devaleenal DB, Natrajan M. Genital tuberculosis in females. Indian J Med Res. 2017 Apr;145(4):425-436. doi: 10.4103/ijmr.IJMR_1550_15.
PubMed 28862174Jindal UN, Verma S, Bala Y. Favorable infertility outcomes following anti-tubercular treatment prescribed on the sole basis of a positive polymerase chain reaction test for endometrial tuberculosis. Hum Reprod. 2012 May;27(5):1368-74. doi: 10.1093/humrep/des076. Epub 2012 Mar 14.
PubMed 22419745Dam P, Shirazee HH, Goswami SK, Ghosh S, Ganesh A, Chaudhury K, Chakravarty B. Role of latent genital tuberculosis in repeated IVF failure in the Indian clinical setting. Gynecol Obstet Invest. 2006;61(4):223-7. doi: 10.1159/000091498. Epub 2006 Feb 13.
PubMed 16479141Jirge PR, Chougule SM, Keni A, Kumar S, Modi D. Latent genital tuberculosis adversely affects the ovarian reserve in infertile women. Hum Reprod. 2018 Jul 1;33(7):1262-1269. doi: 10.1093/humrep/dey117.
PubMed 29897442Bagchi B, Chatterjee S, Gon Chowdhury R. Role of latent female genital tuberculosis in recurrent early pregnancy loss: A retrospective analysis. Int J Reprod Biomed. 2019 Dec 30;17(12):929-934. doi: 10.18502/ijrm.v17i12.5799. eCollection 2019 Dec.
PubMed 32095740
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Short Course Rifapentine and Isoniazid for the Preventive Treatment for Latent Genital Tuberculosis in Women With Recurrent Implantation Failure: A Prospective Interventional Cohort Study
- ClinicalTrials.gov ID
- NCT04528277
- Acronym / sponsor ID
- SCRIPT-LGTB / KS20232
- Conditions
- Infertility, Female, Recurrent Implantation Failure, Genital Tuberculoses, Female, Genital Tuberculosis, Latent
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,050 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Shanghai First Maternity and Infant Hospital
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 27 Aug 2020 (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.
The purpose of this study is to assess the efficacy, safety and tolerability of the 1-month regimen of three times weekly rifapentine plus isoniazid in improving fertility outcome in recurrent implantation failure (RIF) patients with latent genital tuberculosis (LGTB), compared to no treatment and non-LGTB patients.
Detailed description
The prevalence of latent genital tuberculosis (LGTB) is relatively high in women with infertility and recurrent pregnancy loss. Whether preventive treatment of latent tuberculosis infection (LTBI) can improve the fertility outcome in women with recurrent implantation failure (RIF) remains to be explored.
This is a prospective interventional cohort study.The main purpose of this study is to compare the fertility outcome between 1-month regimen of three times weekly rifapentine plus isoniazid and no treatment in RIF patients with LGTB and RIF patients without LGTB. The study will also assess the safety and tolerability and the efficacy of the preventive treatment regimen in prevention of the incidence of active female genital tuberculosis (FGTB).
A total of 1050 participants will be recruited for screening of LGTB. The endometrial tuberculosis (TB) polymerase chain reaction (PCR) test will be employed for the diagnosis of LGTB. Eligible participants with negative TB PCR results will be assigned to the non-LGTB group, while those with positive TB PCR results will be assigned to the LGTB group. The LGTB group will be further assigned, according to their will to receive preventive treatment of tuberculosis, to one of the following groups: the LGTB treatment group and the LGTB no treatment group.
The LGTB treatment group will receive the 1-month regimen of three times weekly rifapentine plus isoniazid, and the in vitro fertilization (IVF)/ intra cytoplasmic sperm injection (ICSI) cycle can be started after 1 month post the completion of the treatment regimen. Adverse events and side effects will be monitored at a 2-week interval during the preventive treatment and followed up once more at 4 weeks post the end of treatment. The LGTB no treatment group and the non-LGTB group will start the IVF/ICSI cycle directly after enrollment without taking any medication related to preventive treatment of tuberculosis.
Eligible participants will be followed up until the end of an IVF/ ICSI cycle or pregnancy. Fertility outcomes of both groups will be recorded and compared. Secondary outcomes, including the incidence of adverse events, the adhesion of treatment and the incidence of LGTB and FGTB, ovarian reserve, embryo quality, history of infertility and tuberculosis will also be recorded and compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LGTB treatment group | Experimental | Drug: rifapentine plus isoniazidThe LGTB treatment group will receive the 1-month regimen of three times weekly rifapentine (150mg per capsule, 450mg po tiw) plus isoniazid (100mg per tablet, 400mg po tiw). |
| LGTB no treatment group | No intervention | –The LGTB no treatment group will not take any medication related to preventive treatment of tuberculosis. |
| non-LGTB group | No intervention | –The non-LGTB group will not take any medication related to preventive treatment of tuberculosis. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women aged 25-40 years old
- Infertile women failed to achieve clinical pregnancy after 4 good quality embryo transfers, with at least 3 fresh or frozen IVF cycles
- Intended to undergo IVF/ICSI
- Ultrasonography or hysterosalpingogram showed a normal uterus cavity, and the thickness of the endometrium was ≥8mm before implantation during last IVF/ICSI cycle
- Patients who voluntarily signed the informed consent and agreed to be followed up as required by the study protocol
Key exclusion criteria (12 listed)
- Use of donor eggs/sperm
- An abnormal uterine cavity shown on hysterosalpingogram or hysteroscopy
- Proven tubal infertility
- Proven preimplantation genetic abnormality
- Proven active 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 |
|---|---|---|
| rifapentine plus isoniazidreceive the 1-month regimen of three times weekly rifapentine (450mg po) plus isoniazid (400mg po) | Drug | LGTB treatment group |
Primary outcome
Clinical pregnancy rates
Time frame: 6 weeks after completion of an IVF/ICSI cycle
Clinical pregnancy was defined as the presence of at least one gestational sac on ultrasound at 6 weeks.
Ongoing Pregnancy Rate
Time frame: 10 weeks after completion of an IVF/ICSI cycle
Ongoing pregnancy was the presence of at least one foetus with heart pulsation on ultrasound beyond 10 weeks.
Miscarriage rate
Time frame: 22 weeks after completion of an IVF/ICSI cycle
The number of miscarriages before 22 weeks divided by the number of participants with positive pregnancy test.
7 secondary outcomes
Implantation rate
Time frame: 6 weeks after completion of an IVF/ICSI cycle
Incidence of LGTB
Time frame: 4 weeks after enrollment
Incidence of FGTB
Time frame: 2 years
Incidence of grade 3 or greater adverse events
Time frame: 20 weeks after preventive treatment initiated
Completion rate of preventive treatment
Time frame: 20 weeks after preventive treatment initiated
Discontinuation of treatment
Time frame: 20 weeks after preventive treatment initiated
Discontinuation of treatment due to side effect of study drugs
Time frame: 20 weeks after preventive treatment initiated
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
- Background: PubMed 28862174Grace GA, Devaleenal DB, Natrajan M. Genital tuberculosis in females. Indian J Med Res. 2017 Apr;145(4):425-436. doi: 10.4103/ijmr.IJMR_1550_15.
- Background: PubMed 22419745Jindal UN, Verma S, Bala Y. Favorable infertility outcomes following anti-tubercular treatment prescribed on the sole basis of a positive polymerase chain reaction test for endometrial tuberculosis. Hum Reprod. 2012 May;27(5):1368-74. doi: 10.1093/humrep/des076. Epub 2012 Mar 14.
- Background: PubMed 16479141Dam P, Shirazee HH, Goswami SK, Ghosh S, Ganesh A, Chaudhury K, Chakravarty B. Role of latent genital tuberculosis in repeated IVF failure in the Indian clinical setting. Gynecol Obstet Invest. 2006;61(4):223-7. doi: 10.1159/000091498. Epub 2006 Feb 13.
- Background: PubMed 29897442Jirge PR, Chougule SM, Keni A, Kumar S, Modi D. Latent genital tuberculosis adversely affects the ovarian reserve in infertile women. Hum Reprod. 2018 Jul 1;33(7):1262-1269. doi: 10.1093/humrep/dey117.
- Background: PubMed 32095740Bagchi B, Chatterjee S, Gon Chowdhury R. Role of latent female genital tuberculosis in recurrent early pregnancy loss: A retrospective analysis. Int J Reprod Biomed. 2019 Dec 30;17(12):929-934. doi: 10.18502/ijrm.v17i12.5799. eCollection 2019 Dec.
- Individual participant dataSharing planned: No
Related trials for Infertility, Female
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingPhase 2
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Functional Hypothalamic Amenorrhea, FHA
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
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?
A Phase 3 study testing rifapentine plus isoniazid in people with Infertility, Female and Recurrent Implantation Failure, 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 5 inclusion and 12 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 27 Aug 2020. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 rates (time frame: 6 weeks after completion of an IVF/ICSI cycle). 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?
On the ClinicalTrials.gov record for NCT04528277, which also lists 5 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 27 Aug 2020; AzTrials last refreshed its copy on 7 Nov 2026.