An interventional study of Fasting in Sub Fertility, Female, Fertility Disorders and Cycle Disorders Menstrual, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to female participants aged 25 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-12-29.
Sponsored by Charite University, Berlin, Germany · Not applicable, Interventional, and Treatment
This exploratory study investigates fasting as a potential supportive therapy in infertility treatment for women suffering from infertility
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.
552 studies on the registry are indexed under Infertility, Female; 137 are open to participants now.
This study's enrollment of 34 is below the median of 100 across 378 interventional studies indexed under Infertility, Female.
Browse Infertility, Female studies →Charite University, Berlin, Germany is the lead sponsor of 857 studies on the registry; 129 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Behavioral: Fasting
waiting list, usual diet should be maintained
Prolonged fasting for 7-10 days (caloric intake \<500 kcal in liquid form)
Qualitative interview analysis of fasting experience
individual and focus group interviews
Time frame: in time frame of 24 weeks after fasting intervention
pregancy rate
pregnancy rate of the participants
Time frame: at baseline, after one month, at end of ovulation induction treatment (2-6 months) and 12 months after baseline
complication rates in pregnancy
complication rates monitored by the gynaecologist, if applicable
Time frame: 12 months after baseline
Hormonal status
FSH, LH, Estrogen, Progesteron
Time frame: at the beginning and end of each ovulatory cycle, for up to 12 months
HbA1c
serum parameter
Time frame: baseline and at end of ovulation induction treatment (2-6 months), for up to 12 months
WHO-5
Quality of life
Time frame: at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
diet
questionnaire to examine dietary behaviour
Time frame: 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
MAAS-questionnaire, validated questionnaire to examine mindfulness
Time frame: 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
HADS-questionnaire, validated questionnaire to examine anxiety and depression
Time frame: 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
ASTS-questionnaire, validated questionnaire to examine current mood
Time frame: at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
experienced stress
Cohen-stress scale, validated questionnaire to examine experienced stress
Time frame: at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
physical fitness
questionnaire to examine physical fitness
Time frame: 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
questionnaire to examine the relationship between the two partners desiring to have a child
Time frame: 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
questionnaire to examine the psychological stress caused by the unfulfilled desire to have children
Time frame: 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
validated questionnaire to examine gratitude
Time frame: 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
ASKU, validated questionnaire to examine self-efficacy
Time frame: 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
sonography in a subgroup
Time frame: before, during and after the fasting intervention
rate of ovulations
ovulation visible in sonography
Time frame: at baseline, after one month, at end of ovulation induction treatment (2-6 months) and 12 months after baseline
liver function parameters
serum liver enzymes
Time frame: at baseline, after one month, at end of ovulation induction treatment (2-6 months), after 12 months
pyruvate in culture medium of oocytes, if applicable (in case of IVF/ICSI)
chemical composition of culture medium (pyruvate)
Time frame: after in vitro fertilisation, if applicable during study period of one year
glucose in culture medium of oocytes, if applicable (in case of IVF/ICSI)
chemical composition of culture medium (glucose)
Time frame: 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)
chemical composition of culture medium (lactate)
Time frame: after in vitro fertilisation, if applicable during study period of one year
Continuous Glucose Monitoring
Continuous Glucose Monitoring via CGM-Device in subgroup
Time frame: 14 days after baseline
Ketone bodies in breath
Breath acetone, in subgroup
Time frame: up to 4 days before, during and up to 7 days after fasting intervention
Cumulative drug dose for ovulation induction
Cumulative dosage of hormonal therapy for each assisted cycle of ovulation induction
Time frame: baseline and until end of treatment for ovulation induction (2-6 months)
Plan to share: Yes — Data will be made available upon request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: after the end of the study for 5 years
Access criteria: on demand.
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Charite University, Berlin, Germany →