Feasibility and Safety of Fasting in Fertility Treatment
- Conditions
- Ovulation; Failure or Lack ofCycle Disorders MenstrualSub Fertility, FemaleOvulation DelayedFertility DisordersSub-fertilityOvulation DisorderOvulation Absent
- Interventions
- Behavioral: Fasting
- Registration Number
- NCT04942457
- Lead Sponsor
- Charite University, Berlin, Germany
- Brief Summary
This exploratory study investigates fasting as a potential supportive therapy in infertility treatment for women suffering from infertility
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 34
- Women aged 25 to 45 years
- Unfulfilled desire to have children >1 year
- declaration of consent
- 20 kg/m² ≤ BMI ≤ 40 kg/m²
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fasting Fasting Participants will be councelled and accompanied to follow a prolonged fasting regime of 7-10 days in an outpatient setting under medical supervision. Additionally qualitative interviews will be conducted by few participants in the experimental arm, as well as their respective Healthcare Providers (Doctors/Medical Staff).
- Primary Outcome Measures
Name Time Method Qualitative interview analysis of fasting experience in time frame of 24 weeks after fasting intervention individual and focus group interviews
pregancy rate at baseline, after one month, at end of ovulation induction treatment (2-6 months) and 12 months after baseline pregnancy rate of the participants
- Secondary Outcome Measures
Name Time Method HbA1c baseline and at end of ovulation induction treatment (2-6 months), for up to 12 months serum parameter
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 Cohen-stress scale, validated questionnaire to examine experienced stress
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 questionnaire to examine the relationship between the two partners desiring to have a child
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 Quality of life
complication rates in pregnancy 12 months after baseline complication rates monitored by the gynaecologist, if applicable
Hormonal status at the beginning and end of each ovulatory cycle, for up to 12 months FSH, LH, Estrogen, Progesteron
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 questionnaire to examine dietary behaviour
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 MAAS-questionnaire, validated questionnaire to examine mindfulness
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 HADS-questionnaire, validated questionnaire to examine anxiety and depression
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 ASTS-questionnaire, validated questionnaire to examine current mood
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 questionnaire to examine the psychological stress caused by the unfulfilled desire to have children
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 validated questionnaire to examine gratitude
abdominal ultrasound after liver wrap before, during and after the fasting intervention sonography in a subgroup
liver function parameters at baseline, after one month, at end of ovulation induction treatment (2-6 months), after 12 months serum liver enzymes
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 questionnaire to examine physical fitness
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 ASKU, validated questionnaire to examine self-efficacy
rate of ovulations at baseline, after one month, at end of ovulation induction treatment (2-6 months) and 12 months after baseline ovulation visible in sonography
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 chemical composition of culture medium (pyruvate)
Ketone bodies in breath up to 4 days before, during and up to 7 days after fasting intervention Breath acetone, in subgroup
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 chemical composition of culture medium (glucose)
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 chemical composition of culture medium (lactate)
Continuous Glucose Monitoring 14 days after baseline Continuous Glucose Monitoring via CGM-Device in subgroup
Cumulative drug dose for ovulation induction baseline and until end of treatment for ovulation induction (2-6 months) Cumulative dosage of hormonal therapy for each assisted cycle of ovulation induction
Trial Locations
- Locations (1)
Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin
🇩🇪Berlin, Germany