NCT04096027已完成4 期
Cabergoline Before or After Oocyte Collection for Follicular Resolution
Fertility Center of Las Vegas1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2019年9月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Discomfort level
研究概览
简要总结
Randomized trial comparing the efficacy of two different times of administration of cabergoline in patients undergoing controlled ovarian stimulation and oocyte collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Laboratory personnel will not be informed of the subject's group assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adult female at least 18 years of age intending to undergo ovarian stimulation for a cycle of IVF.
- •Ability read and understand English sufficiently to obtain informed consent and complete a study diary.
- •Pre-implantation genetic screening (PGS) is allowed.
- •Egg donors are allowed.
- •Patients using a gestational carrier are allowed.
- •Patients with prior IVF cycles are allowed, but no patient can undergo more than one cycle with oocyte collection under this study.
排除标准
- •Egg banking, donor egg banking, or any cycle type that would preclude immediate culture to blastocyst stage.
- •Patients that would be unavailable for the follow-up ultrasound 5 days post-retrieval, such as patients that live far from the clinic (e.g. out of state).
- •Uncontrolled hypertension.
- •Ergot alkaloid hypersensitivity or allergy.
- •History of pulmonary, pericardial, retroperitoneal fibrotic disorders.
- •History of bipolar disorder, schizophrenia, or psychotic illness.
- •Breast feeding.
- •History of eclampsia or pre-eclampsia.
- •Severe hepatic dysfunction.
- •Current use of any dopamine receptor agonist or antagonist for any purpose, including, but not limited to, cabergoline (Dostinex), aripiprazole (Abilify), bromocriptine (Parlodel), methylphenidate (Ritalin), buproprion (Wellbutrin, Zyban), lisdexamfetamine (Vyvanse).
- •Any condition that, in the opinion of the physician or principal investigator, would place the patient at undue risk under this protocol or would otherwise make the protocol inappropriate for that subject.
研究组 & 干预措施
Early administration
Experimental
Cabergoline administered the day before egg collection.
干预措施: Cabergoline Pill (Drug)
Late administration
Experimental
Cabergoline administered after egg collection.
干预措施: Cabergoline Pill (Drug)
结局指标
主要结局
Discomfort level
时间窗: 5 days after egg collection
Self-assessed discomfort level
Mature oocyte rate per follicular puncture
时间窗: Within 24 hours of egg collection
Ratio of mature oocytes obtained to punctured ovarian follicles
次要结局
- M1 oocyte rate(Within 24 hours of egg collection)
- M1 to M2 oocyte ratio(Within 24 hours of egg collection)
- Aneuploidy rate(Within 14 days of egg collection)
- oocyte count(Within 24 hours of egg collection)
- Ovarian volume(5 days post retrieval)
- Oocyte to follicle ratio(Within 24 hours of egg collection)
研究者
研究点 (1)
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