EUCTR2006-000481-37-DE进行中（未招募）不适用
A randomized, open-label clinical trial to identify predictive factors for controlled ovarian stimulation using a fixed daily dose of 200 IU of recombinant FSH in a GnRH antagonist regimen with or without oral contraceptive scheduling
V Organon0 个研究点目标入组 440 人开始时间: 2006年8月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 440
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. Females of couples with an indication for COS and IVF and/or ICSI scheduled for their first COS cycle;
- •2. =18 and =39 years of age at the time of signing informed consent;
- •3. BMI =32 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. Less than 2 ovaries or any other ovarian abnormality (including endometrioma >10 mm; visible on USS);
- •3. Presence of unilateral or bilateral hydrosalphinx (visible on USS);
- •4. Presence of any clinically relevant pathology affecting the uterine cavity upon
- •discretion of the investigator or fibroids = 5 cm;
- •5. History of recurrent miscarriage (3 or more, even when unexplained)
- •6. 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);
- •7. Any clinically relevant abnormal laboratory value (FSH, LH, E2, P, total T, prolactin, TSH,
- •blood biochemistry, hematology and urinalysis) based on a sample taken during the screening phase;
- •8. Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal
- •bleeding, hypersensitivity, ovarian cysts);
- •9. Contraindications for the use of contraceptive steroids;
- •10. Recent history of/or current epilepsy, HIV infection, diabetes, cardiovascular, gastro-intestinal, hepatic,
- •renal or pulmonary disease;
- •11. Abnormal karyotyping of the patient or her partner (if karyotyping is performed);
- •12. History or presence of alcohol or drug abuse within 12 months prior to signing informed consent;
- •13. Use of hormonal preparations within 1 month prior to randomization;
- •14. Hypersensitivity to any of the concomitant medication prescribed as part of the treatment regimen in this
- •15. Administration of investigational drugs within three months prior to signing informed consent.
研究者
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