Feasibility and Safety of Fasting in Fertility Treatment (KiWuA)

Effects of Fasting in Fertility Treatment in Women

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

Study Overview

• Status: Completed
• Conditions: Fertility Disorders; Sub Fertility, Female; Sub-fertility; Ovulation Disorder; Cycle Disorders Menstrual; Ovulation Absent; Ovulation Delayed; Ovulation; Failure or Lack of
• Intervention / Treatment: Behavioral: Fasting

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14109
    • Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 36 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: Karl and Veronica Carstens Foundation
• Investigators: Principal Investigator: Andreas Michalsen, Prof. Dr., Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Actual): December 20, 2023
• Study Completion (Actual): December 20, 2023

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: June 25, 2021
• First Posted (Actual): June 28, 2021

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 28, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: weight loss; complementary medicine; fasting; dietary intervention; caloric restriction; natural therapies; lifestyle modification; dietary restriction; integrative medicine; prolonged fasting
• Additional Relevant MeSH Terms: Pathologic Processes; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Menstruation Disturbances; Infertility; Infertility, Female; Anovulation
• Other Study ID Numbers: KiWuA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be made available upon request.
• IPD Sharing Time Frame: after the end of the study for 5 years
• IPD Sharing Access Criteria: on demand.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No