UnknownPhase 3

Short Course Rifapentine and Isoniazid for the Preventive Treatment for Latent Genital Tuberculosis

China1,050 participantsStarted 2020-09-01

Plain-language 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.

Who can participate

Age range25 Years – 40 Years

SexFEMALE

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Clinical pregnancy rates

Timeframe: 6 weeks after completion of an IVF/ICSI cycle

Ongoing Pregnancy Rate

Timeframe: 10 weeks after completion of an IVF/ICSI cycle

Miscarriage rate

Timeframe: 22 weeks after completion of an IVF/ICSI cycle

Trial details

NCT IDNCT04528277

SponsorHuashan Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-09-01

Contact for this trial

Qiaoling Ruan, Dr.

021-52887946 qlruan07@fudan.edu.cn

View on ClinicalTrials.gov More Infertility, Female trials