A Randomized Double Blinded Trail of DHEA Supplementation for Treatment of Couples With Normal Hysterosalpingogram and Normal Semen Analysis and Evidence of Premature Ovarian Aging (POA).
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 35
- 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 otherwise unexplained infertility and evidence of premature ovarian aging (POA).
详细描述
Recruitment:
Eligible patients will be recruited by advertising on the web and in newspaper. We will screen women under 38 years old with regular menstrual cycles and more than one year of infertility.
Experimental plan:
- Informed consent
- Baseline studies
- Antral follicle counts on Day 2 - 3 of cycle
- Day 3 Serum FSH, LH, E2, Prog, DHEA, DHEAS, testosterone, AMH, Fragile X
- Randomization for pretreatment
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 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •>= 1 year of infertility
- •< 38 years old
- •Normal HSG
- •Normal Semen analysis (Count >= 20 million/ motility > 50%/ Kruger morph > 14%.
- •Regular menses
- •Willingness to sign informed consent for study randomization
- •Willingness to participate in 8 months of non-IVF will he him treatment.
排除标准
- •Abnormal semen analysis
- •Abnormal HSG
- •Baseline FSH/E2 within normal age specific criteria
- •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 eight months of this trial
研究组 & 干预措施
Placebo
Blinded placebo
干预措施: Placebo (Other)
DHEA
Dehydroepiandrosterone (DHEA) administered at a dose of 25 mg tid po. DHEA is a weak androgen produced naturally by the adrenal in men and women. DHEA production is diminished with increasing age. Peak levels of DHEA occur in the late teenage years.
干预措施: Dehydroepiandrosterone (Dietary Supplement)
结局指标
主要结局
Live Birth
时间窗: 24 months
次要结局
- Androgen side effects(12 months)
- Endocrine effects(12 months)
- Clinical Pregnancy(12 months)