Feasibility and Safety of Fasting in Fertility Treatment (KiWuA)

December 28, 2023 updated by: Andreas Michalsen, Charite University, Berlin, Germany

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 34 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Qualitative interview analysis of fasting experience
Time Frame: in time frame of 24 weeks after fasting intervention
individual and focus group interviews
in time frame of 24 weeks after fasting intervention
pregancy rate
Time Frame: at baseline, after one month, at end of ovulation induction treatment (2-6 months) and 12 months after baseline
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
complication rates in pregnancy
Time Frame: 12 months after baseline
complication rates monitored by the gynaecologist, if applicable
12 months after baseline
Hormonal status
Time Frame: at the beginning and end of each ovulatory cycle, for up to 12 months
FSH, LH, Estrogen, Progesteron
at the beginning and end of each ovulatory cycle, for up to 12 months
HbA1c
Time Frame: baseline and at end of ovulation induction treatment (2-6 months), for up to 12 months
serum parameter
baseline and at end of ovulation induction treatment (2-6 months), for up to 12 months
WHO-5
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 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Time Frame: before, during and after the fasting intervention
sonography in a subgroup
before, during and after the fasting intervention
rate of ovulations
Time Frame: at baseline, after one month, at end of ovulation induction treatment (2-6 months) and 12 months after baseline
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
Time Frame: at baseline, after one month, at end of ovulation induction treatment (2-6 months), after 12 months
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)
Time Frame: after in vitro fertilisation, if applicable during study period of one year
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)
Time Frame: after in vitro fertilisation, if applicable during study period of one year
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)
Time Frame: after in vitro fertilisation, if applicable during study period of one year
chemical composition of culture medium (lactate)
after in vitro fertilisation, if applicable during study period of one year
Continuous Glucose Monitoring
Time Frame: 14 days after baseline
Continuous Glucose Monitoring via CGM-Device in subgroup
14 days after baseline
Ketone bodies in breath
Time Frame: up to 4 days before, during and up to 7 days after fasting intervention
Breath acetone, in subgroup
up to 4 days before, during and up to 7 days after fasting intervention
Cumulative drug dose for ovulation induction
Time Frame: baseline and until end of treatment for ovulation induction (2-6 months)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Charite University, Berlin, Germany

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Karl and Veronica Carstens Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andreas Michalsen, Prof. Dr., Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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