The Effect of Endometrial Shedding With Medroxyprogesterone Acetate Prior to Ovulation Induction With Clomiphene Citrate in Oligo-ovulatory and Anovulatory Women: a Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Composite measure of study feasibility
研究概览
简要总结
This is a pilot study examining the feasibility of implementing a large randomized control trial looking at the effect of endometrial shedding with medroxyprogesterone acetate compared to no pre-treatment in women taking clomiphene citrate for ovulation induction for infertility due to oligo-ovulation or anovulation.
详细描述
The purpose of this pilot study is to assess the feasibility of implementing a randomized controlled trial assessing the effect of giving medroxyprogesterone acetate (MPA) to induce a withdrawal bleed compared to a control group of women not receiving MPA on pregnancy rates prior to ovulation induction with clomiphene citrate in oligo-ovulatory and anovulatory women. The primary outcome measure is the effective implementation of the study including a measure of time to recruit 50 patients, physician, nursing and patient compliance rate with the study protocol, and patient satisfaction. Secondary outcome measures include the pregnancy rate per ovulation (where pregnancy is defined as a positive fetal heart rate on ultrasound 2 weeks after a positive pregnancy test), the ovulation rate per cycle started, conception rate per cycle started (where conception is defined as a positive beta-human chorionic gonadotropin level), conception rate per ovulation, time to complete 3 stimulation cycles and endometrial thickness at time of luteinizing hormone surge.
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 (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Oligo-ovulation defined as having less than or equal to 8 menstrual cycles in the past year or inter-menstrual periods of 45 days or longer
- •general good health
- •ability to have timed intercourse or intrauterine insemination
- •no evidence of tubal dysfunction
- •no evidence of a uterine cavity abnormality
- •no evidence of male factor infertility
排除标准
- •a baseline ultrasound showing an endometrial lining greater than 1.0 cm
- •a baseline ultrasound showing an endometrial lining of less than 0.5 cm
- •a positive progesterone level at baseline bloodwork
- •a positive beta human chorionic gonadotropin level at baseline bloodwork
- •body mass index of greater than 40
- •women who have previously taken clomiphene citrate for ovulation induction within the last 6 months
- •women who are taking metformin
- •women who are taking a progestin for luteal phase support.
研究组 & 干预措施
Medroxyprogesterone acetate
Medroxyprogesterone acetate 10mg per os x 10 days prior to starting clomiphene citrate 50mg once daily days 3 - 7 of bleeding after stopping medroxyprogesterone acetate
干预措施: Medroxyprogesterone acetate (Drug)
结局指标
主要结局
Composite measure of study feasibility
时间窗: 2 years
Time to recruit 50 patients; physician, nursing and patient compliance rate with the study protocol; and patient satisfaction.
次要结局
- pregnancy rate per ovulation(2 years)
- ovulation rate per cycle started,(2 years)
- conception rate per cycle started(2 years)
- conception rate per ovulation(2 years)
- time to complete 3 stimulation cycles(2 years)
- time to pregnancy(2 years)
- endometrial thickness at time of luteinizing hormone surge(2 years)