CTRI/2013/06/003749已完成4 期
A multi-centre, open label, randomized, controlled parallel design phase IV study to compare and evaluate the clinical efficacy, safety and patient compliance of Newmon-R� (rhFSH) Pre-filled Syringe versus Gonal-F® Pen 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 120 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Infertile women between 20-39 years of age
- •2.Basal FSH less than 10 IU/L
- •3.Regular menstrual cycles of 24to 35 days of duration
- •4.Antral size follicles more than 5
- •5.Normal functional ovaries and uterus
- •6.Willing to give voluntary written consent
排除标准
- •1.Uterine myoma (fibroids)
- •2.Subjects with primary ovarian failure, uncontrollable hyperthyroidism or secondary adrenal insufficiency
- •3.Body Mass Index more than 30 kg/m2
- •4.Subjects with previous history of ovarian hyperstimulation syndrome 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.HIV or syphilis positive subjects
- •10.History of alcohol or drug addiction
- •11.Subjects smoking more than 5 cigarettes per day
- •12.History of hypersensitivity to rhFSH or other pharmaceutical excipients of this drug
- •13.Positive serum pregnancy test
- •14.Undiagnosed vaginal bleeding
- •15.Subjects unable to understand the objectives, methods, etc. of this clinical study and are unable to comply with the study procedures
- •16.Participation in any other clinical trial within 3 months of registering in this study
研究者
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