EUCTR2004-004771-11-BE进行中（未招募）1 期
A phase III, randomized, double-blind, active-controlled, non-inferiority clinical trial to investigate the efficacy and safety of a single injection of Org 36286 (corifollitropin alfa) to induce multifollicular development for controlled ovarian stimulation using daily recombinant FSH as a reference
V Organon0 个研究点目标入组 1,400 人开始时间: 2006年5月30日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,400
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
入选标准
- •1. Females of couples with an indication for COS and IVF or ICSI;
- •2. =18 and = 36 years of age at the time of signing informed consent;
- •3. Body weight > 60 and = 90 kg and BMI = 18 and = 29 kg/m2;
- •4. Normal menstrual cycle length: 24-35 days;
- •5. Availability of ejaculatory sperm (use of donated and/or cryopreserved sperm is allowed);
- •6. Willing and able to sign informed consent.
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. History of/or any current (treated) endocrine abnormality;
- •2. History of ovarian hyper-response or ovarian hyperstimulation syndrome (OHSS);
- •3. History of/or current polycystic ovary syndrome (PCOS);
- •4. More than 20 basal antral follicles <11 mm (both ovaries combined) as measured
- •on USS in the early follicular phase (menstrual cycle day 2-5);
- •5. Less than 2 ovaries or any other ovarian abnormality (including endometrioma >
- •10 mm; visible on USS);
- •6. Presence of unilateral or bilateral hydrosalphinx (visible on USS);
- •7. Presence of any clinically relevant pathology affecting the uterine cavity or
- •fibroids = 5 cm;
- •8. More than three unsuccessful IVF cycles since the last established ongoing
- •pregnancy (if applicable);
- •9. History of non- or low ovarian response to FSH/hMG treatment;
- •10. History of recurrent miscarriage (3 or more, even when unexplained);
- •11. FSH > 12 IU/L or LH > 12 IU/L as measured by the local laboratory (sample taken
- •during the early follicular phase: menstrual cycle day 2-5);
- •12. Any clinically relevant abnormal laboratory value based on a sample taken during
- •the screening phase;
- •13. Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation,
- •undiagnosed vaginal bleeding, hypersensitivity, ovarian ysts);
- •14. Recent history of/or current epilepsy, HIV infection, diabetes, cardiovascular,
- •gastro-intestinal, hepatic, renal or pulmonary disease;
- •15. Abnormal karyotyping of the patient or her partner (if karyotyping is performed);
- •16. Smoking more than 5 cigarettes per day;
- •17. History or presence of alcohol or drug abuse within 12 months prior to signing
- •informed consent;
- •18. Previous use of Org 36286;
- •19. Use of hormonal preparations within 1 month prior to randomization;
- •20. Hypersensitivity to any of the concomitant medication prescribed as part of the
- •treatment regimen in this protocol;
- •21. Administration of investigational drugs within three months prior to signing
- •informed consent.
研究者
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