Efficacy of Metoclopramide in Poor Ovarian Response IVF Patients: a Randomised, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of oocytes
研究概览
简要总结
Poor ovarian response population of ART are considered the biggest challenge for providers. Hitherto, no one protocol has been proven to be effect in this subgroup of IVF patients.
Metoclopramide belongs to the antiemetic group, used for motion sickness and during early gestation for hyperemesis gravidarum.
The mechanism of action is antagonisim to dopamine receptors. We hypothesize than by blocking dopamine receptors and decreasing the dopaminergic tone there is a possibility to increase the sensitivity of ovarian response to gonadotropins during controlled ovarian stimulation and result in increased oocyte retrival.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 54 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Poor response according to "Bologna criteria"
排除标准
- •Allergy to metoclopramide
- •Prolactinemia
- •Women treated with dopamine agonists
研究组 & 干预措施
Metoclopramide 10 mg BID
干预措施: Metoclopramide (Drug)
Placebo 10 mg BID
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Number of oocytes
时间窗: Approximately 5 weeks from first dose of study drug
Number of oocytes
次要结局
未报告次要终点
研究者
Leon Grin
Gynecological Doctor
Barzilai Medical Center