NCT00948857终止2 期
A Randomized Double Blinded Trail of DHEA Supplementation for Treatment of Couples With Premature Ovarian Failure (POF).
David H. Barad1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2009年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Live Birth
研究概览
简要总结
The experimental focus of this project is on the interaction of DHEA treatment on pregnancy in women with open tubes, fertile male partners and evidence of premature ovarian failure.
详细描述
Recruitment:
- New patients presenting for Donor egg cycles
- Possible print, magazine or Radio advertisement
Experimental plan:
- Informed consent
- Baseline studies
- Antral follicle counts
- Serum FSH, LH, E2, Prog, DHEA, DHEAS, testosterone, AMH, Fragile X
- Randomization
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •>= 1 year of infertility
- •>21 and <40 years old
- •Normal HSG
- •Normal Semen analysis (Count >= 20 million/ motility > 50%/ Kruger morph > 14%.
- •Absent menses
- •Willingness to sign informed consent for study randomization
- •Willingness to participate in 3 months of treatment.
排除标准
- •Abnormal semen analysis
- •Abnormal HSG
- •Medical condition that would contraindicate pregnancy, ovulation induction or general anesthesia
- •Family history of significant genetic disease, or factor V leiden thrombophilia
- •Inability to present for monitoring visits
- •Inability to follow medication instruction
- •Desire to undergo other fertility treatments before completing three months of this trial
研究组 & 干预措施
DHEA Placebo
Placebo Comparator
Blinded placebo
干预措施: Placebo (Dietary Supplement)
DHEA active treatment
Experimental
Dehydroepiandrosterone 25 mg tid po
干预措施: Dehydroepiandrosterone (Dietary Supplement)
结局指标
主要结局
Live Birth
时间窗: 9 months
Live Birth outcome compared between DHEA active treatment and Placebo
Live Birth
时间窗: 24 months
次要结局
- Endocrine Effects(12 months)
- Androgen Side Effects(12 months)
- Clinical Pregnancy(12 months)
研究者
David H. Barad
Director of Clinical Research
Center for Human Reproduction
研究点 (1)
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