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临床试验/NCT01856062
NCT01856062Unknown4 期

Ovulation Induction With Clomiphene Citrate and Dexamethasone

San Antonio Military Medical Center1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2013年5月最近更新:
适应症
干预措施

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

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

Experimental

Oral dexamethasone will be added to clomiphene citrate

干预措施: Dexamethasone (Drug)

Clomiphene plus placebo

Placebo Comparator

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

申办方类型
Fed
责任方
Principal Investigator
主要研究者

Jeremy King

Reproductive Endocrinologist

San Antonio Military Medical Center

研究点 (1)

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