Ovulation Induction With Clomiphene Citrate and Dexamethasone
试验速览
- 阶段
- 4 期
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Pregnancy
研究概览
简要总结
The purpose of this study is to determine if the addition of dexamethasone to clomiphene citrate will increase the pregnancy rate of intrauterine insemination (IUI) cycles.
详细描述
For decades clomiphene citrate (CC) has been the first line therapy for ovulation induction in anovulatory or oligoovulatory women, and for superovulation in women with unexplained infertility or partners with mild sperm abnormalities. While approximately 80% of patients achieve ovulation with CC, less than half conceive. Pregnancy is achieved in approximately 10% of ovulatory cycles.
Addition of dexamethasone to CC has been shown to result in pregnancy rates of 21-40% in CC-resistant women (defined as patients failing to ovulate on CC alone). A subsequent randomized controlled trial demonstrated higher pregnancy rates in patients with unexplained infertility undergoing intrauterine insemination (IUI) with CC + dexamethasone compared to those taking CC alone.
In light of the relatively high pregnancy rates achieved in previous trials, we hypothesize that dexamethasone as an adjunct to CC will increase the ovulation rate and pregnancy rate for all appropriate candidates for IU with a standard CC regimen.
Our study is designed to randomize patients undergoing ovulation induction with IUI into two groups: one consisting of a standard CC regimen, and the other consisting of the same CC regimen with the addition of daily dexamethasone. The primary outcome measure is pregnancy.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Active duty military members or dependents seeking infertility treatment at Brooke Army Medical Center
- •primary or secondary infertility
- •candidate for intrauterine insemination (IUI)
排除标准
- •Severe male factor infertility (total motile sperm count <10 million/mL)
- •Bilateral fallopian tube obstruction
- •Diminished ovarian reserve (baseline follicle stimulating hormone > 20)
- •History of clomiphene resistance as determined by a Clomid challenge test or prior non-ovulatory cycles while taking clomiphene
- •Known or suspected hypopituitarism or hypothalamic amenorrhea
- •Six or more prior therapeutic CC cycles without a pregnancy
- •Renal impairment, hepatitis, hepatic cirrhosis, or myasthenia gravis
- •Osteoporosis
- •Cataracts or glaucoma
- •Congenital Adrenal Hyperplasia, Cushing's disease, or any condition requiring chronic corticosteroid use
研究组 & 干预措施
Clomiphene plus dexamethasone
Oral dexamethasone will be added to clomiphene citrate
干预措施: Dexamethasone (Drug)
Clomiphene plus placebo
A placebo of dexamethasone will be given with clomiphene citrate
干预措施: Placebo (Drug)
结局指标
主要结局
Pregnancy
时间窗: 12 weeks
Determined by serum hCG measurement
次要结局
- Clinical pregnancy(12 weeks)
研究者
Jeremy King
Reproductive Endocrinologist
San Antonio Military Medical Center
