Traditional Clomiphene Citrate Administration Versus a Stair-Step Approach: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Time to Ovulation With Each Protocol
研究概览
简要总结
The purpose of this study is to compare the length of time to achieve ovulation and pregnancy with a traditional protocol administration of clomiphene citrate versus a stair step administration.
Our hypothesis is by using a stair-step approach in which a period is not induced between administrations of escalating doses of clomiphene citrate, the time to ovulation and pregnancy may be reduced.
详细描述
The traditional administration of clomiphene citrate for ovulation induction involves taking clomiphene citrate for 5 days. If ovulation does not occur within 14 days, a progestin pill (such as Provera) is prescribed for 10 days to induce a period (which normally occurs within 1 week of stopping the pill). Then a higher dose of clomiphene citrate will be prescribed.
The stair-step administration of clomiphene citrate for ovulation induction also involves taking clomiphene citrate for 5 days. In contrast, if ovulation does not occur within 7-9 days, a progestin pill (such as Provera) would NOT be taken to induce a period. The dose of clomiphene will then be increased. Therefore, this would do away with the 10 days of taking the progestin pill, and also do away with waiting for a period (usually 3 to 7 days) for a total of up to a 20 day difference between clomiphene citrate dosing cycles.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ovulatory dysfunction as evidenced by mid-luteal progesterone less then 3ng/dL, non-biphasic basal body temperature charting, or menstrual history of cycles > 35 days.
- •Female patients 18 to 45 years old
- •Six months or greater of unprotected intercourse without pregnancy.
- •Normal TSH and prolactin serum levels
- •Semen analysis of male partner with > 15 million motile sperm on semen analysis.
- •NOTE: Must be willing to travel to the Oklahoma City area for treatment.
排除标准
- •Failure to spontaneously menstruate or to menstruate following progestin administration
- •Allergy or intolerance to the side effects of clomiphene citrate, hCG (human chorionic gonadotropins), or medroxyprogesterone acetate (Provera).
- •Known anatomical defect affecting the uterine cavity including submucosal fibroids or endometrial polyps.
- •Know tubal hydrosalpinx or risk factors for tubal obstruction
- •Known liver dysfunction
- •Known or suspected androgen secreting tumor, cushings disease, or adrenal hyperplasia (congenital or adult onset)
- •Ovarian cyst > 20mm or endometrial lining >6 mm on trans-vaginal baseline ultrasound.
- •Stage III or IV endometriosis
- •Decreased ovarian reserve as evidenced by antral follicle count less than 6 by Transvaginal ultrasound or a cycle-day-3 serum FSH of > 10 uIU/ml.
- •Positive HIV in either the female patient or her partner.
研究组 & 干预措施
Traditional Administration
The traditional approach to ovulation induction with clomiphene citrate involves administration of 50mg/day for five days (starting on cycle day 3, 4, or 5). If ovulation does not occur then a progestin is prescribed to induce menses (which occurs within one week of stopping the progestin) and then a higher dose of medication is used in the next cycle.
干预措施: clomiphene citrate (Drug)
Stair-Step Administration
The stair-step protocol the dose of clomiphene citrate would be increased without administering progestin and inducing a period. This would eliminate the days of progestin (10 days) and the waiting for the period (usually 3 to 7 days) and finally waiting to start clomiphene citrate on cycle day 3 at the earliest (3 more days) for a total of up to 20 days difference for the 100 mg dose of clomid. If they did not ovulate on 100mg, then the process repeats and another 20 days before they start 150mg. Therefore, the time to ovulation and pregnancy may be reduced, and hopefully pregnancy, by using the stair-step protocol. This method utilizes ultrasound monitoring for follicle development before increasing the dose of clomiphene citrate.
干预措施: clomiphene citrate (Drug)
结局指标
主要结局
Time to Ovulation With Each Protocol
时间窗: 5 years
We hypothesized that time to ovulation would be shorter with stair-step protocol vs. traditional.
次要结局
- Rate of Ovulation(5 years)
- Delivery Outcomes(5 years)