NCT00440180终止3 期
The Role of Aromatase Inhibitors in the Treatment of Infertility in Obese Male
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pregnancy Rate
研究概览
简要总结
Obesity is associated with an increase in blood levels of estrogen. Estrogen or "female hormone" is believed to have a negative effect on sperm production. Aromatase inhibitors such as anastrozole work to decrease the production of estrogen and increase testosterone in the body. By decreasing the level of estrogen, sperm production should improve. In this study, the investigators will try to determine the benefit of anastrozole in obese men and follow pregnancy outcomes.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male partner of a couple presenting for infertility work up after one year of unprotected intercourse
- •Moderate oligozoospermia (defined as mean sperm count ≤ 20 × 106/mL and ≥ than 3 × 106/mL) of at least two separate occasions spanning a minimum of two weeks
- •Obese men BMI ≥ 30
- •FSH and LH levels < 10 mIU/mL
排除标准
- •Severe Oligozoospermia: Sperm count < than 3 × 106/mL, including azoospermia
- •Age less than 18 or greater than 65 years
- •Pyospermia or leukospermia: defined by white blood cells ≥ 1 million leukocytes per milliliter of semen
- •Cryptorchidism
- •Vasectomy reversal
- •Regular use of tobacco products
- •Use of anabolic steroids or testosterone replacement
- •All patients with abnormal initial liver function tests "AST or ALT" will be excluded form the study
研究组 & 干预措施
Group B
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
Group A
Experimental
Anastrozole
干预措施: Anastrozole (Drug)
结局指标
主要结局
Pregnancy Rate
时间窗: 4 months
Partner pregnancy rate during study participation
次要结局
未报告次要终点
研究者
研究点 (1)
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