Effects of Fasting on Success Rates of Assisted Reproductive Techologies (KiWuC)

Effects of Fasting on Success Rates of In-vitro-fertilization (IVF) / Intracytoplasmatic Sperm Injection (ICSI) in Women With Fertility Disorders

This exploratory study investigates fasting as a potential supportive therapy for infertility treatment in women undergoing in-vitro-fertilization (IVF) / intracystoplamsatic sperm injection (ICSI)

Study Overview

• Status: Terminated
• Conditions: Fertility Issues; Fertility Disorders; IVF; Sub Fertility, Female; Sub-fertility
• Intervention / Treatment: Behavioral: Fasting

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• 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: 25 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

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
Experimental: Fasting group; Participants will be councelled and accompanied to follow a fasting regime of 7 days in an outpatient setting under medical supervision.	Behavioral: Fasting; fasting for 7 days (caloric intake <500 kcal in liquid form); Other Names: Prolonged Fasting
No Intervention: Waiting list; This group maintains their individual diet during the whole time of the study. In case that the first cycle of In-Vitro-Fertilization fails, they are offered a fasting intervention before a next cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fertilisation rate	Fertilisation rate of the retrieved oocytes	throughout 1-3 days after in-vitro-fertilization (IVF) / intracytoplasmatic sperm injection (ICSI)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
glucose in culture medium of oocytes	chemical composition of culture medium (glucose)	throughout 1-3 days after in vitro fertilisation
lactate in culture medium of oocytes	chemical composition of culture medium (lactate)	throughout 1-3 days after in vitro fertilisation
pyruvate in culture medium of oocytes	chemical composition of culture medium (pyruvate)	throughout 1-3 days after in vitro fertilisation
pregnancy rate	pregnancies after IVF/ICSI	4 weeks after IVF/ICSI
rate of mature oocytes	rate of mature oocytes	at IVF / ICSI intervention
rate of life births	rate of life births after IVF/ICSI	10 months after IVF/ICSI
rate of implantable embryos	rate of implantable embryos after the IVF/ICSI	at IVF/ICSI
Course of IVF/ICSI preparation and pregnancy	Course of IVF/ICSI preparation and pregnancy	4 weeks and 10 months after IVF / ICSI
WHO-5 questionnaire	Quality of life	baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
changes in diet	self-developed questionnaire to examine dietary behaviour	baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
mindfulness	MAAS-questionnaire, validated questionnaire to examine mindfulness	baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
anxiety and depression	HADS-questionnaire, validated questionnaire to examine anxiety and depression	baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
current mood	ASTS-questionnaire, validated questionnaire to examine current mood	baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
experienced stress	Cohen-stress scale, validated questionnaire to examine experienced stress	baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
physical fitness	questionnaire to examine physical fitness	baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
quality of relationship	self-developed questionnaire to examine the relationship between the two partners desiring to have a child	baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
psychological stress caused by the unfulfilled desire to have children	self-developed questionnaire to examine the psychological stress caused by the unfulfilled desire to have children	baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
gratitude	validated questionnaire to examine gratitude	baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
self-efficacy	ASKU, validated questionnaire to examine self-efficacy	baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
abdominal sonography	sonography in a subgroup	within 1 month before, during and within 2 weeks after the fasting intervention

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): August 3, 2021
• Primary Completion (Actual): December 12, 2022
• Study Completion (Actual): December 12, 2022

Study Registration Dates

• First Submitted: July 24, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 10, 2021

Study Record Updates

• Last Update Posted (Actual): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: complementary medicine; fasting; dietary intervention; caloric restriction; natural therapies; lifestyle modification; dietary restriction; integrative medicine; Intracytoplasmatic sperm injection ICSI
• Additional Relevant MeSH Terms: Infertility; Infertility, Female
• Other Study ID Numbers: KiWuC

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; Statistical Analysis Plan (SAP); Informed Consent Form (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