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
LG Life Sciences India Pvt Ltd5 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2012年7月30日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 5
- 主要终点
- Total number of oocytes retrieved
研究概览
简要总结
This study is a multi-centre, open label, randomised, parallel active controlled phase IV study to compare and evaluate the clinical efficacy, safety and patient compliance of Newmon-R™ (rhFSH) Pre-filled Syringe with Gonal-F® Pen in Infertile Women undergoing Controlled Ovarian Hyperstimulation for Assisted Reproductive Technologies. All patients treatment will be followed according to long gonadotropin releasing hormone agonist protocol. 120 patients will be enrolled and data will be analysed using appropriate statistical tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 39.00 Year(s)（—）
- 性别
- Female
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.
结局指标
主要结局
Total number of oocytes retrieved
时间窗: At the end of one IVF cycle
次要结局
- Total administration dosage of rhFSH(Duration of rhFSH stimulation)
研究者
研究点 (5)
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