NCT00464607已完成3 期
A Prospective, Randomized, Controlled Clinical Study on the Assessment of Tolerability and of Clinical Efficacy of MERIONAL® (hMG-IBSA) Administered Subcutaneously Versus MERIONALâ Administered Intramuscularly in Women Undergoing Controlled Ovarian Hyperstimulation (COH) in an ART Programme (IVF)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 8
- 主要终点
- Number of oocytes recovered
研究概览
简要总结
Purpose of the study is the evaluation of the tolerability (both local and systemic) and the clinical efficacy (in terms oocytes recovered) of subcutaneously versus intramuscularly administered Merional® (IBSA, Lugano - CH) in patients undergoing controlled ovarian hyperstimulation (COH) in an ART programme (IVF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients
- •aged between 20 and 40 years
- •undergoing ovarian stimulation for the purposes of oocyte retrieval in an assisted conception programme
- •Body Mass Index (BMI) 20-28 kg/m2
- •early follicular phase FSH level < 9 IU/l.
排除标准
- •ascertained or presumptive hypersensitivity to the active principle and/or their ingredients
- •primary ovarian failure
- •ovarian cysts or enlargement not due to polycystic ovarian syndrome
- •oocyte donation
- •abnormal bleeding of undetermined origin
- •patients who have exhibited poor response or requiring doses of more than 300 IU daily in previous treatment cycles or those who have received similar therapies (previous treatment cycles) in the 30 days prior to the beginning of the present study
- •uncontrolled thyroid or adrenal dysfunction
- •neoplasia
- •severe impairment of the renal and/or hepatic functions
- •diabetes and active thrombophlebitis, cardiopathies and epilepsy
- •presence of clinically significant systemic disease or any contraindication of being pregnant and/or carrying out a pregnancy to term
- •presence of any anatomical abnormality of the reproductive system
- •being pregnant or breastfeeding
- •menopause
结局指标
主要结局
Number of oocytes recovered
次要结局
- Efficacy: Day of Oocyte collection, 17β-estradiol Cmax, Total dose of gonadotrophin (IU) or n° of vials and n° of vials/day,Number of mature follicles (follicles ³ 16 mm in diameter) on hCG day (or one day earlier), Clinical pregnancy rate
- Tolerability: Number of Adverse Events (AEs) experienced during the study, Occurrence of Ovarian Hypestimulation Syndrome (OHSS), Local tolerability at the injection site, Haematological-biochemical laboratory tests, before and after treatment,
研究者
研究点 (8)
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