NCT04528277

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,050

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 22, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 27, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

August 27, 2020

Status Verified

August 1, 2020

Enrollment Period

1 year

First QC Date

August 22, 2020

Last Update Submit

August 26, 2020

Conditions

Infertility, FemaleRecurrent Implantation FailureGenital Tuberculoses, FemaleGenital Tuberculosis, Latent

Outcome Measures

Primary Outcomes (3)

  • Clinical pregnancy rates

    Clinical pregnancy was defined as the presence of at least one gestational sac on ultrasound at 6 weeks.

    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.

    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.

    22 weeks after completion of an IVF/ICSI cycle

Secondary Outcomes (7)

  • Implantation rate

    6 weeks after completion of an IVF/ICSI cycle

  • Incidence of LGTB

    4 weeks after enrollment

  • Incidence of FGTB

    2 years

  • Incidence of grade 3 or greater adverse events

    20 weeks after preventive treatment initiated

  • Completion rate of preventive treatment

    20 weeks after preventive treatment initiated

  • +2 more secondary outcomes

Study Arms (3)

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).

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.

Interventions

rifapentine plus isoniazidDRUG

receive the 1-month regimen of three times weekly rifapentine (450mg po) plus isoniazid (400mg po)

LGTB treatment group

Eligibility Criteria

Age25 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai First Maternity and Infant Hospital

Shanghai, Shanghai Municipality, 200051, China

Location

Related Publications (5)

  • 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.

    PMID: 28862174BACKGROUND

  • Jindal 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.

    PMID: 22419745BACKGROUND

  • Dam 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.

    PMID: 16479141BACKGROUND

  • Jirge 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.

    PMID: 29897442BACKGROUND

  • Bagchi 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.

    PMID: 32095740BACKGROUND

MeSH Terms

Conditions

Infertility, FemaleTuberculosis, Female Genital

Interventions

rifapentineIsoniazid

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertilityTuberculosis, UrogenitalTuberculosis, ExtrapulmonaryTuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

HydrazinesOrganic ChemicalsIsonicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Central Study Contacts

Qiaoling Ruan, Dr.

CONTACT

021-52887946qlruan07@fudan.edu.cn

Xiaoming Teng, Dr.

CONTACT

021-54035206tengxiaoming@51mch.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director of department of infectious diseases

Study Record Dates

First Submitted

August 22, 2020

First Posted

August 27, 2020

Study Start

September 1, 2020

Primary Completion

September 1, 2021

Study Completion

September 1, 2022

Last Updated

August 27, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)