NCT01969201已完成4 期
Randomised Clinical Trial Comparing Highly Purified FSH Formulation (Fostimon®) and Recombinant FSH (Gonal-F®) in GnRH-antagonist Controlled Ovarian Hyperstimulation Cycles.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 710
- 试验地点
- 16
- 主要终点
- Clinical Pregnancy Rate
研究概览
简要总结
The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety of two different subcutaneous FSH preparations (Fostimon versus Gonal-F) for controlled ovarian hyperstimulation in a GnRH-antagonist cycle.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 18-38 years old;
- •BMI: 18-28 kg/m2;
- •Less than 3 previously completed IVF cycles;
- •Basal FSH <10 IU/L and E2 <80 pg/ml;
- •TSH < 2.5 mIU/L
- •>10 and <30 antral follicles 2-10 mm in size for both ovaries combined
- •AMH: >1 ng/ml (7.15 pmol/l) and <5.6 ng/ml (40.0 pmol/l)
- •Presence and adequate visualization of both ovaries;
- •Within 12 months of the beginning of the study, uterine cavity consistent with expected normal function as assessed through transvaginal ultrasound, hysterosalpingogram, sonohysterogram or hysteroscopic examination;
排除标准
- •Primary ovarian failure or women known as poor responders;
- •PCO and PCOS;
- •Severe OHSS in a previous COH cycle;
- •Uterine malformation that may impair the possibility to get pregnant;
- •Ovarian cysts >10 mm;
- •Hydrosalpinx that have not been surgically removed or ligated;
- •Endometriosis stage 3 or 4;
- •Oocyte donation;
- •Severe male factor;
- •Pathologies associated with any contraindication of being pregnant;
- •History of recurrent miscarriage (more than 3 previous miscarriages);
- •Hypersensitivity to the study medication;
- •Abnormal bleeding of undetermined origin;
- •Uncontrolled thyroid or adrenal dysfunction;
- •Neoplasias;
- •Severe impairment of renal and/or hepatic function.
研究组 & 干预措施
Fostimon®
Experimental
75 IU/vial, powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone,IBSA Institut Biochimique SA)
干预措施: Urofollitrophin (Drug)
Gonal-F®
Active Comparator
75 IU/vial powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone; Merck Serono)
干预措施: Follitrophin alpha (Drug)
结局指标
主要结局
Clinical Pregnancy Rate
时间窗: 8 weeks
A clinical pregnancy is defined as a pregnancy showing ultrasound embryonic heart activity at 8 weeks of gestation;
次要结局
- Delivery Rate(9 months)
- Cumulative Pregnancy Rate(2 years)
- Embryo Quality (Number of Top Quality Embryos Transferred Per Patient)(On culture day 3)
- Positive Serum Pregnancy Test Rate(2 weeks after embryo transfer)
- Number of Follicles >16 mm on the Day of hCG Injection(10-15 days after starting FSH stimulation)
- Total Number of Oocytes Retrieved(end of treatment period, approximately 2 - 3 weeks.)
- Fertilization Rate(end of treatment period, approximately 2 - 3 weeks)
研究者
研究点 (16)
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