Effects of Fasting on Success Rates of In-vitro-fertilization (IVF) / Intracytoplasmatic Sperm Injection (ICSI) in Women With Fertility Disorders
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Fertilisation rate
研究概览
简要总结
This exploratory study investigates fasting as a potential supportive therapy for infertility treatment in women undergoing in-vitro-fertilization (IVF) / intracystoplamsatic sperm injection (ICSI)
详细描述
This 2-arm, randomized, controlled exploratory clinical trial aims to explore fasting as a novel supportive treatment in female infertility during IVF / ICSI. The participants will be randomized in two groups: a fasting group and a waiting list. The intervention group follows a fasting intervention, whereas the patients on the waiting list continue their normal diet. All groups will be trained and accompanied by medical experts. 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 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 25 to 38 years with planned IVF / ICSI
- •1 ng/ml ≤ Anti-Mullerian Hormone (AMH) ≤ 4 ng/ml
- •Unfulfilled desire to have children >1 year
- •25 kg/m² ≤ BMI ≤ 35 kg/m² declaration of consent
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
Fertilisation rate
时间窗: throughout 1-3 days after in-vitro-fertilization (IVF) / intracytoplasmatic sperm injection (ICSI)
Fertilisation rate of the retrieved oocytes
次要结局
- rate of mature oocytes(at IVF / ICSI intervention)
- lactate in culture medium of oocytes(throughout 1-3 days after in vitro fertilisation)
- pyruvate in culture medium of oocytes(throughout 1-3 days after in vitro fertilisation)
- pregnancy rate(4 weeks after IVF/ICSI)
- glucose in culture medium of oocytes(throughout 1-3 days after in vitro fertilisation)
- rate of implantable embryos(at IVF/ICSI)
- rate of life births(10 months after IVF/ICSI)
- WHO-5 questionnaire(baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline)
- mindfulness(baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline)
- physical fitness(baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline)
- quality of relationship(baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline)
- Course of IVF/ICSI preparation and pregnancy(4 weeks and 10 months after IVF / ICSI)
- changes in diet(baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline)
- gratitude(baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline)
- abdominal sonography(within 1 month before, during and within 2 weeks after the fasting intervention)
- anxiety and depression(baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline)
- current mood(baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline)
- experienced stress(baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline)
- psychological stress caused by the unfulfilled desire to have children(baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline)
- self-efficacy(baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline)
研究者
Andreas Michalsen
Prof. Dr. med.
Charite University, Berlin, Germany