Optimizing Fertility Treatment in Women With Polycystic Ovary Syndrome (PCOS) - A Randomized Controlled Trial: The Role of Progestin-induced Endometrial Shedding in PCOS (PIES in PCOS)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Live Birth
研究概览
简要总结
Progestin-induced endometrial shedding (PIES) followed by clomiphene citrate is fertility treatment of choice in anovulatory women with polycystic ovary syndrome (PCOS). However, some preliminary data suggest that skipping PIES could result in a higher live birth rate. The investigators are performing the first randomized controlled trial to find out if skipping the use of progestin during fertility treatment of anovulatory PCOS women is associated with improved pregnancy and live birth rates compared to the traditional approach of using progestin prior to use of clomiphene citrate.
详细描述
This is a prospective randomized trial of clomiphene citrate (CC) preceded by progestin-induced endometrial shedding (PIES) vs CC without PIES in the treatment of infertility in patients with PCOS, for up to 5 treatment cycles.
Participants will be randomized to receive either progestin followed by CC starting on day 3 of the induced menses, or CC without induced menses. Study participants will be monitored at regular 2 to 4 wks intervals for response to medication using ultrasound and hormonal parameters. The maximum dose of CC will not exceed 750 mg/cycle. Treatment will not exceed 5 ovulatory cycles. Participants who are resistant to 150 mg of CC will exit the study.
170 anovulatory PCOS women actively seeking pregnancy, aged 18 through 40 years will be enrolled and randomized in a 1:1 treatment ratio into the two study arms. Anovulation will be the only infertility factor in all patients.
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
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group A (No PIES)
Subjects randomized to this group will receive clomiphene citrate (CC) without using progestin throughout their treatment course.
- CC 50 mg oral for 5 days ("Days 3-7")
- If no ovulation, CC 100 mg for 5 days ("Days 12-16")
- If no ovulation, CC 150 mg for 5 days ("Day 21-25")
- Exit study if no response to 150 mg CC, or if no pregnancy after 5 ovulatory cycles
干预措施: Clomiphene Citrate (Drug)
Group B (PIES Group)
Women randomized to this group will receive progestin to induce endometrial shedding before starting any doses of clomiphene citrate (CC)
- Progestin 10 mg oral for 10 days to induce endometrial shedding (PIES)
- CC 50 mg oral for 5 days (Day 3-7)
- If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding (starting on CD28) and CC 100 mg x 5 days, starting on day 3 of induced menses
- If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding, and CC 150 mg for 5 days
- Exit study if no response to 150 mg CC, or if no pregnancy after 5 ovulatory cycles
干预措施: Progestin (Drug)
Group B (PIES Group)
Women randomized to this group will receive progestin to induce endometrial shedding before starting any doses of clomiphene citrate (CC)
- Progestin 10 mg oral for 10 days to induce endometrial shedding (PIES)
- CC 50 mg oral for 5 days (Day 3-7)
- If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding (starting on CD28) and CC 100 mg x 5 days, starting on day 3 of induced menses
- If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding, and CC 150 mg for 5 days
- Exit study if no response to 150 mg CC, or if no pregnancy after 5 ovulatory cycles
干预措施: Clomiphene Citrate (Drug)
结局指标
主要结局
Live Birth
时间窗: Within 36 weeks of a positive pregnancy test
Delivery of a viable infant after 24 weeks of pregnancy
次要结局
未报告次要终点
研究者
Albert Asante, MD MPH
Assistant Professor of Obstetrics-Gynecology, Consultant in Reproductive Endocrinology and Infertility
University of Illinois at Chicago