NCT00702351已完成2 期
A Phase II, Uncontrolled Pilot Trial to Evaluate That a Single Dose of 100 μg or 150 μg Org 36286 (Corifollitropin Alfa) is Able to Induce Multiple Follicular Growth During the First Week of Controlled Ovarian Stimulation for IVF or ICSI Using a Long Protocol of GnRH Agonist (Study 38833)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- serum inhibin-B levels; follicle number and follicle size distribution
研究概览
简要总结
To evaluate the induction of multiple follicular growth after single dose administration of 100 μg or 150 μg Org 36286 in a long protocol of GnRH agonist.
详细描述
In this trial, all subjects were (pre)treated daily with subcutaneous triptorelin, a GnRH agonist which is known to provide profound suppression of endogenous LH and FSH. It was evaluated whether these down-regulated subjects show an appropriate ovarian response to 100 μg or 150 μg Org 36286 during the first week of stimulation. To evaluate this, follicular growth was measured by USS, and serum inhibin-B and E2 levels were assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females of couples with an indication for controlled ovarian stimulation (COS) and IVF or ICSI that have had at least one previous COS cycle with proven normal ovarian response;
- •>=18 and <= 39 years of age at the time of signing informed consent;
- •a. First group: Body weight >= 50 kg and BMI >= 18 and <= 29 kg/m^2; b. Second group: Body weight <= 60 kg and BMI <= 29 kg/m^2;
- •Normal menstrual cycle length: 24-35 days;
- •Ejaculatory sperm (use of donated and/or cryopreserved sperm is allowed);
- •Normal routine diagnostic hysteroscopy and endometrial biopsy;
- •Willing and able to sign informed consent.
排除标准
- •History of or any current (treated) endocrine abnormality;
- •History of ovarian hyper-response1 or history of ovarian hyperstimulation
- •syndrome (OHSS);
- •History of or current polycystic ovary syndrome (PCOS);
- •A basal antral follicle count > 20 (size < 11 mm, both ovaries combined) on USS during the early follicular phase (menstrual cycle day 2-5);
- •Less than 2 ovaries or any other ovarian abnormality;
- •Presence of unilateral or bilateral hydrosalpinx (visible on USS);
- •Presence of unilateral or bilateral endometriomas (>10 mm; visible on USS);
- •More than three unsuccessful COS cycles since the last established ongoing
- •pregnancy (if applicable);
- •History of non- or low ovarian response to FSH/hMG treatment;
- •FSH or LH > 12 IU/L as measured by the local laboratory (sample taken during the early follicular phase: menstrual cycle day 2-5);
- •Any clinically relevant abnormal laboratory value based on a sample taken during the screening phase;
- •Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts) or GnRH analogues (e.g. hypersensitivity, pregnancy/lactation);
- •Recent history of or current epilepsy, diabetes or cardiovascular, gastro-intestinal, hepatic, renal or pulmonary disease;
- •History or presence of alcohol or drug abuse within 12 months prior to signing informed consent;
- •Previous use of Org 36286;
- •Use of hormonal preparations within 1 month prior to screening;
- •Administration of investigational drugs within three months prior to signing
- •informed consent.
研究组 & 干预措施
Arm 1
Experimental
150 µg Org 36286 (corifollitropin alfa)
干预措施: Org 36286 (corifollitropin alfa) (Drug)
Arm 2
Experimental
100 µg Org 36286 (corifollitropin alfa)
干预措施: Org 36286 (corifollitropin alfa) (Drug)
结局指标
主要结局
serum inhibin-B levels; follicle number and follicle size distribution
时间窗: One cycle
次要结局
- Amount of recFSH needed from Stimulation Day 8 onwards to the Day of hCG; Endocrinological parameters (FSH, LH, E2, P); Number and quality of oocytes retrieved(One cycle)
- Number of fertilized oocytes; Fertilization rate; Number and quality of embryos; Implantation rate; Miscarriage rate; Clinical outcome(One cycle)
研究者
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