EUCTR2016-005208-24-GR进行中（未招募）1 期
A prospective, multicenter, double-blind, randomized, placebo-controlled, two-parallel groups Phase IIIb clinical study, to assess the efficacy and safety of adding low doses of hCG at a short IVF protocol with GnRH agonist and controlled ovular stimulation with recombinant FSH (rFSH) at the beginning of the follicular phase and during the whole stimulation period in infertile women of older age who are undergoing IVF, on the number of embryos to be transferred
Prof. Harry Siristatidis0 个研究点目标入组 100 人开始时间: 2017年5月5日最近更新:
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试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1.Age: between 35 and 40 years,
- •2.Normal menstrual cycle (cycle duration: 24-35 days),
- •3.Normal endocrine function (normal values of PRL and TSH, FSH = 15 IU/ml),
- •4.Transvaginal ultrasound without abnormal findings,
- •5.Medical history devoid of any finding,
- •6.Indication for IVF/ICSI (NICE, 2016)
- •7.1st or 2nd IVF/ICSI cycle
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.?ndocrine or metabolic diseases, e.g. PCO (S)
- •2.Presence of any uterine or endometrium pathology,
- •3.Pelvic inflammatory disease (PID),
- •4.Basic FSH levels > 15 IU / ml,
- •5.Previous ovaries surgical intervention,
- •6.BMI = 35 kg/m2,
- •7.Age: < 35 & > 40 years
研究者
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