NCT00335894已完成3 期
A Prospective, Randomized, Investigator-blind, Controlled, Clinical Study of Phase III on the Efficacy and Tolerability of hMG-IBSA (IBSA) vs Menopur (Ferring) Administered s.c. in Women Undergoing 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
- 144
- 试验地点
- 4
- 主要终点
- total number of oocytes retrieved 34 - 36 hours after hCG administration.
研究概览
简要总结
Multicenter, prospective, randomized, investigator blind, controlled clinical trial. Two parallel groups, one receiving the test drug hMG (hMG-IBSA, IBSA Institut Biochimique sa) and the other the reference drug hMG (Menopur, Ferring Pharmaceuticals, Inc.).
详细描述
The purpose of the study is to evaluate the clinical efficacy and general tolerability of two different subcutaneous hMG preparations (hMG-IBSA, IBSA vs Menopur, Ferring Pharmaceuticals, Inc.) when administered to patients undergoing controlled ovarian stimulation for 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
- Single
入排标准
- 年龄范围
- 18 Years 至 36 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women undergoing ovarian stimulation for IVF with or without ICSI (intracytoplasmic sperm injection) and with the following characteristics:
- •Voluntary given informed consent to study participation in writing encompassing consent to data recording and verification procedures;
- •> 18/= and < 37 years old;
- •BMI between 18 and 28 kg/m2;
- •Less than 3 previous completed IVF cycles;
- •Basal FSH level less than 10 IU/L once within 6 months prior to the study;
- •Within 12 month of the beginning of the study, uterine cavity consistent with expected normal function as assessed through a hysterosalpingogram, or sonohysterogram, or hysteroscopic examination or TVUS;
- •Normal or clinically insignificant haematology and blood chemistry values.
排除标准
- •Primary ovarian failure or women known as poor responders;
- •Signs of PCO, according to the Rotterdam Criteria;
- •At least one ovary inaccessible for oocyte retrieval;
- •One or more ovarian cysts > 10 mm;
- •Hydrosalpinx that have not been surgically removed or ligated;
- •Stage III or IV endometriosis;
- •Patients affected by pathologies associated with any contraindication of being pregnant;
- •Hypersensitivity to the study medication;
- •Abnormal bleeding of undetermined origin;
- •Uncontrolled thyroid or adrenal dysfunction;
- •Neoplasias;
- •PAP smear III within the last 2 years;
- •Severe impairment of the renal and/or hepatic functions;
- •Lactation;
- •Hyperprolactinaemia;
- •Participation in a concurrent clinical trial or in another trial within the past four weeks;
- •Use of concomitant medication that might interfere with study evaluations.
结局指标
主要结局
total number of oocytes retrieved 34 - 36 hours after hCG administration.
次要结局
- Total dose of hMG (IU); number of days of hMG stimulation and stimulation duration; cancellation rate with reasons; 17β-estradiol (E2) serum concentration; number of follicles >16 mm.
- number of mature oocytes and inseminated oocytes; fertilization rate.
- embryo score; number of transferred embryos; implantation rate, number of transferred embryos; clinical pregnancy rate
- Tolerability evaluation
研究者
研究点 (4)
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