Effect of Progestin-Induced Endometrial Shedding on Ovulation Induction Cycles With Clomiphene Citrate: A Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Clinical pregnancy rate per ovulation
研究概览
简要总结
Women with polycystic ovary syndrome (PCOS) can suffer from infertility because they do not produce an egg each month, resulting in irregular periods. As a result, these women often need a medication called clomiphene citrate (clomiphene) to induce ovulation. A traditional 'clomiphene protocol' begins with a short course of progestin treatment to bring on a period (termed a 'withdrawal bleed') before starting the clomiphene medication. Newer evidence, however, has suggested that this progestin-induced shedding of the uterine lining (i.e., withdrawal bleed) may decrease the chances of pregnancy. The purpose of our study is to determine whether withdrawal bleeding has an impact on pregnancy rates for patients with PCOS undergoing a clomiphene cycle.
It is hypothesized that patients who undergo ovulation induction with clomiphene citrate without prior endometrial shedding will have higher clinical pregnancy rates than those who begin with a progestin-induced withdrawal bleed.
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 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Polycystic ovary syndrome (Rotterdam 2003 Consensus Criteria) and a diagnosis of anovulatory infertility
- •Age 18-38 years
- •At least 1 patent fallopian tube (as demonstrated by hysterosalpingogram, hydrotubation or hysterosonogram within the last year)
- •Normal semen analysis (total motile sperm count >20million/ml)
- •Normal uterine cavity (as demonstrated by hysterosalpingogram, hydrotubation or hysterosonogram within the last year)
- •Undergoing ovulation-induction with clomiphene citrate without intra-uterine insemination (IUI)
排除标准
- •Body mass index (BMI) < 17 kg/m2 or > 40 kg/m2
- •Prior treatment with clomiphene citrate
- •Presence of a hydrosalpinx (as seen on ultrasound, hysterosalpingogram, hydrotubation or hysterosonogram)
- •Those with systemic disease such as diabetes mellitus, uncontrolled thyroid disease, systemic lupus erythematosus and antiphospholipid antibody syndrome
- •Any other cause of infertility other than anovulation
研究组 & 干预措施
No withdrawal bleed
No progestin prior to ovulation induction with clomiphene citrate
干预措施: Progestin (Drug)
结局指标
主要结局
Clinical pregnancy rate per ovulation
时间窗: 6 weeks after starting clomiphene
clinical pregnancy rate (gestational sac seen on ultrasound approximately 6-7 weeks after starting clomiphene) per ovulation
次要结局
- ovulation rate(assessed 1 month after each induced ovulation cycle)
- ongoing pregnancy rate(assessed 12 weeks after clinical pregnancy is acheived)
- endometrial thickness(Assessed at 1 month after conception)
- cumulative pregnancy rate(assessed 9 months after the ovulation induction cycles)
- miscarriage rate(Assessed 4 months after clinical pregnancy acheived)
- multiple pregnancy rate(Assessed 4 months after clinical pregnancy acheived)