Infertility, Female Clinical Trial
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.
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.
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