Prospective, multicentric, open label, clinical study to evaluate efficacy and safety of R-TPR-013 in patients undergoing treatment for infertility

Reliance Life Sciences Pvt Ltd0 个研究点目标入组 102 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Patients with BMI between 18-29 kg/m2 (both inclusive) at the time of screening.
•2. Female subjects age 18 years to 37 years (both inclusive) at the time of screening.
•3. Infertile females of couples undergoing for controlled ovarian hyperstimulation (COH)

•1. History of clinically significant endocrine related abnormality 2. Any ovarian and/or abdominal abnormality interfering with ultrasound examination 3. History of clinically significant diseases e.g. epilepsy, diabetes, cardiovascular, gastro-intestinal, hepatic, renal, pulmonary, or abdominal disease or PCOS 4. Subjects positive for HIV, HBsAg, HCV. 5. Subject participation in another clinical trial 30 days prior to administration of IP. 6. Any other condition which investigator feels would pose a significant hazard to subject if IP is administered. 7. Subject with history of alcohol or drug abuse within 12 months prior to signing informed consent.

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