NCT04942457已完成不适用
Effects of Fasting in Fertility Treatment in Women
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Qualitative interview analysis of fasting experience
研究概览
简要总结
This exploratory study investigates fasting as a potential supportive therapy in infertility treatment for women suffering from infertility
详细描述
This 2-arm, randomized, controlled exploratory clinical trial aims to explore fasting as a novel supportive treatment in infertility. The participants will be randomized in two groups: fasting and waiting list. All groups will be trained and accompanied by medical experts and dieticians. In addition, qualitative interviews will be conducted including individual and focus group interviews with a subgroup of participants.
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
- Single (Outcomes Assessor)
盲法说明
It is not possible to mask a fasting intervention for the participant or the study personel. Therefore only outcome assessors are masked.
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 25 to 45 years
- •Unfulfilled desire to have children >1 year
- •declaration of consent
- •20 kg/m² ≤ BMI ≤ 40 kg/m²
排除标准
- •Language barriers
- •Previously known serious mental illness or cognitive impairment
- •Patients with anatomical/organic damage and proven uterine abnormalities
- •Eating disorders in the medical history
- •Serious previous internal diseases
- •Lack of internet access
- •No consent to randomisation
- •Participation in other studies
结局指标
主要结局
Qualitative interview analysis of fasting experience
时间窗: in time frame of 24 weeks after fasting intervention
individual and focus group interviews
pregancy rate
时间窗: at baseline, after one month, at end of ovulation induction treatment (2-6 months) and 12 months after baseline
pregnancy rate of the participants
次要结局
- HbA1c(baseline and at end of ovulation induction treatment (2-6 months), for up to 12 months)
- experienced stress(at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline)
- quality of relationship(at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline)
- WHO-5(at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline)
- complication rates in pregnancy(12 months after baseline)
- Hormonal status(at the beginning and end of each ovulatory cycle, for up to 12 months)
- diet(at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline)
- mindfulness(at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline)
- anxiety and depression(at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline)
- current mood(at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline)
- psychological stress caused by the unfulfilled desire to have children(at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline)
- gratitude(at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline)
- abdominal ultrasound after liver wrap(before, during and after the fasting intervention)
- liver function parameters(at baseline, after one month, at end of ovulation induction treatment (2-6 months), after 12 months)
- physical fitness(at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline)
- self-efficacy(at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline)
- rate of ovulations(at baseline, after one month, at end of ovulation induction treatment (2-6 months) and 12 months after baseline)
- pyruvate in culture medium of oocytes, if applicable (in case of IVF/ICSI)(after in vitro fertilisation, if applicable during study period of one year)
- Ketone bodies in breath(up to 4 days before, during and up to 7 days after fasting intervention)
- glucose in culture medium of oocytes, if applicable (in case of IVF/ICSI)(after in vitro fertilisation, if applicable during study period of one year)
- lactate in culture medium of oocytes, if applicable (in case of IVF/ICSI)(after in vitro fertilisation, if applicable during study period of one year)
- Continuous Glucose Monitoring(14 days after baseline)
- Cumulative drug dose for ovulation induction(baseline and until end of treatment for ovulation induction (2-6 months))
研究者
Andreas Michalsen
Prof. Dr. med.
Charite University, Berlin, Germany
研究点 (2)
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