EUCTR2015-005682-24-DK进行中（未招募）1 期
REDUCING THE IMPACT OF OVARIAN STIMULATION - THE RIOT PROJECTSTUDY RIOT A: THE ROLE OF AROMATASE INHIBITOR IN REDUCING THE DETRIMENTAL EFFECTS OF OVARIAN STIMULATION TO OPTIMIZE OUTCOMES IN FRESH EMBRYO TRANSFER CYCLES - RIOT-A
Sven Olaf Skouby, Professor, MD, DMSc. Unit of Reproductive Medicine, Herlev/Gentofte Hospital0 个研究点目标入组 128 人开始时间: 2016年1月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 128
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
- •Indication for IVF/ICSI treatment
- •Eligible for IVF/ICSI treatment according to local criteria
- •IVF/ICSI treatment with single embryo transfer
- •Regular cycles 21-35 days (both included)
- •AMH 8- 32 (both included)
- •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 128
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Any contraindication for IVF/ICSI treatment according to local criteria
- •Previous stimulation for IVF/ICSI with < 4 oocytes obtained
- •Undergoing IVF/ICSI for the purpose of fertility preservation
- •Allergy towards study drug
- •After inclusion the participants will be excluded from further participation in the trial in case of
- •?Withdrawal of consent
- •?Lack of compliance with study medication
- •?Medical complications arising from IVF treatment that would require the cycle to be terminated on clinical grounds
- •?Serious adverse event or reaction including severe allergy to study drug or developing an excessive response to ovarian hyperstimulation in the follicular phase for which termination of all medication was required.
- •?Specific adverse reactions to study drug: severe degree of hot flushes, severe degree of nausea/vomiting, severe degree of muscle and joint pain.
- •Participants who are withdrawn from the study will be replaced by inclusion of new participants.
- •Should the study participant present with ovarian cyst or inadequate endometrium thickness according to local guidelines on the initial ultrasound scan, the participant will be managed according to local clinical policies. The participant can be randomized when she is considered ready to commence ovarian stimulation according to local protocols.
- •In case of a low response to stimulation resulting in cancellation of the cycle before oocyte retrieval, or when no embryos are available for transfer, the participant will be withdrawn from further participation. Both instances will be addressed in the report of results.
研究者
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