Effect of Rapamycin in Ovarian Aging
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Measure of Ovarian Reserve
研究概览
简要总结
The investigators are proposing a prospective, randomized, double-blind, placebo-controlled pilot study assessing the ability of low-dose rapamycin to delay ovarian aging in women. Animal studies have shown the potential of rapamycin in slowing or reversing some age-associated pathways.
详细描述
One of the earliest and most profound changes associated with human aging is the rapid decline in ovarian follicular activity and reproductive capacity. Beginning around age 35, fertility rates decline as the number and quality of oocytes fall, culminating in the onset of menopause around age 51. The onset of menopause has profound socioeconomic, quality of life, and health implications, including increasing the risks of cardiovascular disease, osteoporosis, cognitive decline and dementia. While human lifespan has increased, the age of menopause has remained largely unchanged, leaving more women living an ever-larger proportion of their lives in a postmenopausal state. The narrow reproductive window adds socioeconomic pressure on women to complete childbearing within a limited timeframe, or preserve their fertility with egg or embryo freezing. The investigators and others have demonstrated that rapamycin can delay ovarian aging in mice.
The purpose of this pilot study is to determine whether the same may be true in humans. Extending the reproductive lifespan will reduce the time pressure on women to complete childbearing and will allow more women to spend more of their lives in the premenopausal status and delay the negative healthy consequences of menopause.
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
- 35 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 35-45 years
- •In the menopausal transition stage -3a
- •Have been unable to conceive based on diminished ovarian reserve and who have failed to develop any euploid embryos with IVF or who do not desire to conceive within the next 1.5 years
- •Have regular menstrual periods (with less than 7 days of variability)
- •Early follicular phase follicle stimulating hormone (FSH) levels ] < 20 mIU/mL
- •Anti-müllerian hormone (AMH) levels of >0.1 ng/mL
- •Antral Follicle Counts (AFC) of >3
排除标准
- •Women with irregular menstrual cycles
- •Severe ovarian deficiency, or with no evidence of remaining follicles
- •Kidney or liver disease
- •Any significant medical disease, including cancer
- •Contraindications to receiving rapamycin
研究组 & 干预措施
Placebo
Participants randomized to the placebo arm will receive placebo orally, for 12 weeks (3 months).
干预措施: Placebo (Other)
Rapamycin
Participants randomized to the treatment arm will receive 5mg/week of rapamycin orally, for 12 weeks (3 months).
干预措施: Rapamycin (Drug)
结局指标
主要结局
Measure of Ovarian Reserve
时间窗: Up to 1 year
Ovarian reserve will be determined using AMH
次要结局
- Klotho Level(Day 21 of menstrual cycle)
- TVU(Up to 1 year)
- Estradiol (E2) Level(Day 21 of menstrual cycle)
- FSH Level(Day 21 of menstrual cycle)
研究者
Samuel Zev Williams
Associate Professor of Obstetrics and Gynecology
Columbia University