Graceful Lifestyle Changes Intervention Study for Women With PCOS and Infertility
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 主要终点
- Ovulation Occurence
研究概览
简要总结
The purpose of this study is to help women with PCOS to improve their symptoms and ovulation rate through a lifestyle intervention program which introduces a specific diet, a physical activity regimen and mindfulness exercises to improve psychological well-being and overall health.
详细描述
- Purpose
The purpose of this study is to:
- assess if implementing lifestyle changes through instruction and coaching is as effective as standard ovulation-induction therapy,
- evaluate if myo-inositol is an effective addition to both lifestyle intervention and standard fertility medications, and
- evaluate how each of four main sub-types of PCOS will respond to our lifestyle intervention program.
- Hypothesis:
The investigators hypothesize that implementing lifestyle changes in women with PCOS will help restore ovulation by balancing reproductive hormones and increasing sensitivity to insulin. Lifestyle changes will also help to manage common PCOS symptoms and therefore, increase psychological well-being and quality of life in this population of women. In addition to a low-glycemic diet, physical activity, and stress reduction, a diet supplemented with myo-inositol will create further hormonal homeostasis and improve metabolic functioning. Finally, the investigators believe that the distinct sub-types of PCOS will respond differently to the proposed lifestyle intervention program and therefore, this will demonstrate that diet, activity and stress reduction is an effective approach to fertility for some individuals, but not others.
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
- None
入排标准
- 年龄范围
- 18 Years 至 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •all women with PCOS trying to conceive who are between 18 and 37 years of age (PCOS will be defined using the Rotterdam criteria)
排除标准
- •women who have already began fertility treatment
- •women who are taking myo-inositol or have taken it in the past three months
- •women being treated for or who have a history of an eating disorder
研究组 & 干预措施
Graceful Lifestyle Changes & MYO
The 12-week lifestyle intervention will incorporate three lifestyle changes: a low-glycemic diet, increased exercise, and stress reduction through meditation and mindfulness.
In addition, this group will take myo-inositol (6 grams in juice or water every morning).
干预措施: Graceful Lifestyle Changes (Behavioral)
Graceful Lifestyle Changes & MYO
The 12-week lifestyle intervention will incorporate three lifestyle changes: a low-glycemic diet, increased exercise, and stress reduction through meditation and mindfulness.
In addition, this group will take myo-inositol (6 grams in juice or water every morning).
干预措施: Myo-inositol (Dietary Supplement)
Graceful Lifestyle Changes
The 12-week lifestyle intervention will incorporate three lifestyle changes: a low-glycemic diet, increased exercise, and stress reduction through meditation and mindfulness.
In addition, this group will take a white powder placebo (6 grams in juice or water every morning).
干预措施: Graceful Lifestyle Changes (Behavioral)
Letrozole & MYO
The women assigned to the fertility medication group will be prescribed letrozole. The initial dose will be 5 mg daily for five days and the dose can be increased by 2.5 mg to a total daily dose of 7.5 mg if necessary depending on ovulatory response, as in clinical practice. This treatment regimen will continue for three cycles (approximately the same period of time as the treatment group) or until pregnancy is achieved.
In addition, this group will take myo-inositol (6 grams in juice or water every morning).
干预措施: Myo-inositol (Dietary Supplement)
Letrozole & MYO
The women assigned to the fertility medication group will be prescribed letrozole. The initial dose will be 5 mg daily for five days and the dose can be increased by 2.5 mg to a total daily dose of 7.5 mg if necessary depending on ovulatory response, as in clinical practice. This treatment regimen will continue for three cycles (approximately the same period of time as the treatment group) or until pregnancy is achieved.
In addition, this group will take myo-inositol (6 grams in juice or water every morning).
干预措施: Letrozole (Drug)
Letrozole
The women assigned to the fertility medication group will be prescribed letrozole. The initial dose will be 5 mg daily for five days and the dose can be increased by 2.5 mg to a total daily dose of 7.5 mg if necessary depending on ovulatory response, as in clinical practice. This treatment regimen will continue for three cycles (approximately the same period of time as the treatment group) or until pregnancy is achieved.
In addition, this group will take a white powder placebo (6 grams in juice or water every morning).
干预措施: Letrozole (Drug)
结局指标
主要结局
Ovulation Occurence
时间窗: 12 weeks
Ovulation is the primary outcome and expressed as any ovulation (categorical "yes" or "no") during the 12-week (84-day) study. This length allows observation of 3 potential ovulatory cycles. The upper limit of a normal ovulatory cycle is 35 days, so to accommodate for this, documentation of ovulation with a progesterone test may extend to the end of week 14.
Ovulation Frequency
时间窗: 12 weeks
Ovulation is the primary outcome can be expressed in according to frequency (nominal "0", "1", "2, or "3") during the 12-week (84-day) study. This length allows observation of 3 potential ovulatory cycles. The upper limit of a normal ovulatory cycle is 35 days, so to accommodate for this, documentation of ovulation with a progesterone test may extend to the end of week 14.
次要结局
- Conception(12 weeks)
- Stress(12 weeks)
- Anxiety(12 weeks)
- Depression(12 weeks)
- Quality of Life(12 weeks)