EUCTR2017-004433-93-DK
进行中（未招募）
1 期
RIOT C: REDUCING THE IMPACT OF OVARIAN STIMULATION. NOVEL APPROACHES TO LUTEAL SUPPORT IN IVF. STUDY 2. - RIOT C. STUDY 2.
icholas Stephen Macklon, Professor, MD, PhD0 个研究点目标入组 26 人2017年11月15日
适应症Ovarian stimulation in oocyte donationMedDRA version: 20.0Level: LLTClassification code 10071130Term: Controlled ovarian stimulationSystem Organ Class: 100000004865MedDRA version: 20.0Level: LLTClassification code 10072100Term: Egg donorSystem Organ Class: 100000004869Therapeutic area: Not possible to specify
相关药物Letrozol Accord
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Ovarian stimulation in oocyte donation
- 发起方
- icholas Stephen Macklon, Professor, MD, PhD
- 入组人数
- 26
- 状态
- 进行中（未招募）
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Meet the clinical criteria for acceptance as oocyte donors
- •Regular ovulatory cycle of 26\-30 days.
- •Age: \= 35 years (the age limit for donating eggs in Denmark)
- •Written 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 26
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
排除标准
- •Contraindications for ovarian stimulation or OPU according to local guidelines
- •Allergy towards study drug
- •Exclusion of patients after earlier inclusion in the study in case of
- •\-Patient withdrawal of consent
- •\-Lack of compliance with medication
- •\-Medical complications arising from IVF treatment that requires the cycle to be terminated
- •\-Serious adverse event (SAE) or serious adverse reaction (SAR) including severe allergy to study drug.
- •\-Specific adverse reactions to study drug: severe degree of hot flushed, severe degree of nausea/vomiting, severe diarrhea, severe degree of muscle and joint pain.
- •In case of exclusion of a patient after earlier inclusion in the study, a new patient will be included.
结局指标
主要结局
未指定
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