Prospective, multicentric, open label, clinical study to evaluate efficacy and safety of R-TPR-020 in patients undergoing treatment for infertility.

Reliance Life Sciences Pvt Ltd0 个研究点目标入组 45 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Female subjects age 18 years to 40 years (both inclusive) at the time of screening.
•2.Infertile females of couples undergoing for controlled ovarian hyperstimulation (COH) or patients undergoing treatment for Polycystic ovarian syndrome (PCOS).
•3.Patients with BMI between 18-29 kg/m2 (both inclusive) at the time of screening.

•1.History of clinically significant endocrine related abnormality
•2.History / presence of undiagnosed vaginal bleeding
•3.History of primary ovarian failure
•4.Any ovarian and/or abdominal abnormality interfering with ultrasound examination;
•5.History of clinically significant diseases, e.g. epilepsy, diabetes, cardiovascular, gastro-intestinal, hepatic, renal, pulmonary, or abdominal disease
•6.Use of hormonal preparations within one month prior to the start of FSH with the exception of thyroid medication.

发起方