A multi-centre, open label, randomized, controlled parallel design phase IV study to compare and evaluate the clinical efficacy and safety of IVF-Mâ?¢ (Menotropin) versus MenopurÂ® (Menotropin) in Infertile Women undergoing Controlled Ovarian Hyperstimulation for Assisted Reproductive Technologies

G Life Sciences India Pvt Ltd0 个研究点目标入组 60 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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•Regular menstrual cycles of 24 to 35 days of duration, Normal basal FSH and LH during the early follicular phase, antral size follicles more than 5, Normal functional ovaries and uterus, Infertility due to any of the following factors: tubal factor, endometriosis (stage 1 or 2), male factor or unexplained factor, Willing to give voluntary written consent

•1.Uterine myoma (fibroids)
•2.Subjects with primary ovarian failure, uncontrollable hyperthyroidism or secondary adrenal insufficiency
•3.Body Mass Index 30 kg/m2
•4.Subjects with previous history of ovarian hyperstimulation syndrome (OHSS) in the previous IVF cycles
•5.More than 3 previously consecutive unsuccessful IVF cycles
•6.Any significant systemic disease, endocrine or metabolic abnormalities
•7.Tumors of the ovary, breast, uterus, hypothalamus or pituitary gland
•8.Ovarian cysts or enlarged ovaries, not related to polycystic ovarian disease (PCOD)
•9.Intracranial bleeding
•10.An organic intracranial lesion such as pituitary tumor
•11.HIV or syphilis positive subjects
•12.History of alcohol or drug addiction
•13.Subjects smoking more than 5 cigarettes per day
•14.History of hypersensitivity to hMG or other pharmaceutical excipients of this drug
•15.Positive serum pregnancy test
•16.Undiagnosed vaginal bleeding
•17.Subjects unable to understand the objectives, methods, etc. of this clinical study and are unable to comply with the study procedures
•18.Participation in any other clinical trial within 3 months of registering in this study

发起方

G Life Sciences India Pvt Ltd