Feasibility and Safety of Fasting in Fertility Treatment

Study Overview
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Brief Summary
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This exploratory study investigates fasting as a potential supportive therapy in infertility treatment for women suffering from infertility

Detailed Description
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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.

Official Title
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Effects of Fasting in Fertility Treatment in Women

Conditions
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Sub Fertility, Female, Fertility Disorders, Cycle Disorders Menstrual, Ovulation Disorder, Ovulation Absent, Ovulation Delayed, Ovulation; Failure or Lack of, Sub-fertility

Intervention / Treatment
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* Behavioral: Fasting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 25 to 45 years Unfulfilled desire to have children >1 year declaration of consent 20 kg/m² ≤ BMI ≤ 40 kg/m² Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There are 2 parallel groups following different nutritional regimes. Additionally Qualitative Interviews with Patients and Doctors/Medical Staff.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fasting<br>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<br>* Prolonged fasting for 7-10 days (caloric intake <500 kcal in liquid form)<br>|
| No Intervention: Control group<br>waiting list, usual diet should be maintained | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative interview analysis of fasting experience | individual and focus group interviews | in time frame of 24 weeks after fasting intervention | 
| pregancy rate | pregnancy rate of the participants | at baseline, after one month, at end of ovulation induction treatment (2-6 months) and 12 months after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication rates in pregnancy | complication rates monitored by the gynaecologist, if applicable | 12 months after baseline | 
| Hormonal status | FSH, LH, Estrogen, Progesteron | at the beginning and end of each ovulatory cycle, for up to 12 months | 
| HbA1c | serum parameter | baseline and at end of ovulation induction treatment (2-6 months), for up to 12 months | 
| WHO-5 | Quality of life | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | before, during and after the fasting intervention | 
| rate of ovulations | ovulation visible in sonography | 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 | 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) | 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) | 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) | after in vitro fertilisation, if applicable during study period of one year | 
| Continuous Glucose Monitoring | Continuous Glucose Monitoring via CGM-Device in subgroup | 14 days after baseline | 
| Ketone bodies in breath | Breath acetone, in subgroup | 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 | baseline and until end of treatment for ovulation induction (2-6 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fasting, natural therapies, caloric restriction, lifestyle modification, dietary restriction, dietary intervention, prolonged fasting, weight loss, complementary medicine, integrative medicine