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Feasibility and Safety of Fasting in Fertility Treatment (KiWuA)

Primary Purpose

Sub Fertility, Female, Fertility Disorders, Cycle Disorders Menstrual

Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Fasting
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sub Fertility, Female focused on measuring fasting, natural therapies, caloric restriction, lifestyle modification, dietary restriction, dietary intervention, prolonged fasting, weight loss, complementary medicine, integrative medicine

Eligibility Criteria

25 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Fasting

Control group

Arm Description

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).

waiting list, usual diet should be maintained

Outcomes

Primary Outcome Measures

Qualitative interview analysis of fasting experience
individual and focus group interviews
pregancy rate
pregnancy rate of the participants

Secondary Outcome Measures

complication rates in pregnancy
complication rates monitored by the gynaecologist, if applicable
Hormonal status
FSH, LH, Estrogen, Progesteron
HbA1c
serum parameter
WHO-5
Quality of life
diet
questionnaire to examine dietary behaviour
mindfulness
MAAS-questionnaire, validated questionnaire to examine mindfulness
anxiety and depression
HADS-questionnaire, validated questionnaire to examine anxiety and depression
current mood
ASTS-questionnaire, validated questionnaire to examine current mood
experienced stress
Cohen-stress scale, validated questionnaire to examine experienced stress
physical fitness
questionnaire to examine physical fitness
quality of relationship
questionnaire to examine the relationship between the two partners desiring to have a child
psychological stress caused by the unfulfilled desire to have children
questionnaire to examine the psychological stress caused by the unfulfilled desire to have children
gratitude
validated questionnaire to examine gratitude
self-efficacy
ASKU, validated questionnaire to examine self-efficacy
abdominal ultrasound after liver wrap
sonography in a subgroup
rate of ovulations
ovulation visible in sonography
liver function parameters
serum liver enzymes
pyruvate in culture medium of oocytes, if applicable (in case of IVF/ICSI)
chemical composition of culture medium (pyruvate)
glucose in culture medium of oocytes, if applicable (in case of IVF/ICSI)
chemical composition of culture medium (glucose)
lactate in culture medium of oocytes, if applicable (in case of IVF/ICSI)
chemical composition of culture medium (lactate)
Continuous Glucose Monitoring
Continuous Glucose Monitoring via CGM-Device in subgroup
Ketone bodies in breath
Breath acetone, in subgroup
Cumulative drug dose for ovulation induction
Cumulative dosage of hormonal therapy for each assisted cycle of ovulation induction

Full Information

First Posted
May 10, 2021
Last Updated
September 12, 2023
Sponsor
Charite University, Berlin, Germany
Collaborators
Karl and Veronica Carstens Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04942457
Brief Title
Feasibility and Safety of Fasting in Fertility Treatment
Acronym
KiWuA
Official Title
Effects of Fasting in Fertility Treatment in Women
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Karl and Veronica Carstens Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sub Fertility, Female, Fertility Disorders, Cycle Disorders Menstrual, Ovulation Disorder, Ovulation Absent, Ovulation Delayed, Ovulation; Failure or Lack of, Sub-fertility
Keywords
fasting, natural therapies, caloric restriction, lifestyle modification, dietary restriction, dietary intervention, prolonged fasting, weight loss, complementary medicine, integrative medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There are 2 parallel groups following different nutritional regimes. Additionally Qualitative Interviews with Patients and Doctors/Medical Staff.
Masking
Outcomes Assessor
Masking Description
It is not possible to mask a fasting intervention for the participant or the study personel. Therefore only outcome assessors are masked.
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fasting
Arm Type
Experimental
Arm Description
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).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
waiting list, usual diet should be maintained
Intervention Type
Behavioral
Intervention Name(s)
Fasting
Intervention Description
Prolonged fasting for 7-10 days (caloric intake <500 kcal in liquid form)
Primary Outcome Measure Information:
Title
Qualitative interview analysis of fasting experience
Description
individual and focus group interviews
Time Frame
in time frame of 24 weeks after fasting intervention
Title
pregancy rate
Description
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
Secondary Outcome Measure Information:
Title
complication rates in pregnancy
Description
complication rates monitored by the gynaecologist, if applicable
Time Frame
12 months after baseline
Title
Hormonal status
Description
FSH, LH, Estrogen, Progesteron
Time Frame
at the beginning and end of each ovulatory cycle, for up to 12 months
Title
HbA1c
Description
serum parameter
Time Frame
baseline and at end of ovulation induction treatment (2-6 months), for up to 12 months
Title
WHO-5
Description
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
Title
diet
Description
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
Title
mindfulness
Description
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
Title
anxiety and depression
Description
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
Title
current mood
Description
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
Title
experienced stress
Description
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
Title
physical fitness
Description
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
Title
quality of relationship
Description
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
Title
psychological stress caused by the unfulfilled desire to have children
Description
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
Title
gratitude
Description
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
Title
self-efficacy
Description
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
Title
abdominal ultrasound after liver wrap
Description
sonography in a subgroup
Time Frame
before, during and after the fasting intervention
Title
rate of ovulations
Description
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
Title
liver function parameters
Description
serum liver enzymes
Time Frame
at baseline, after one month, at end of ovulation induction treatment (2-6 months), after 12 months
Title
pyruvate in culture medium of oocytes, if applicable (in case of IVF/ICSI)
Description
chemical composition of culture medium (pyruvate)
Time Frame
after in vitro fertilisation, if applicable during study period of one year
Title
glucose in culture medium of oocytes, if applicable (in case of IVF/ICSI)
Description
chemical composition of culture medium (glucose)
Time Frame
after in vitro fertilisation, if applicable during study period of one year
Title
lactate in culture medium of oocytes, if applicable (in case of IVF/ICSI)
Description
chemical composition of culture medium (lactate)
Time Frame
after in vitro fertilisation, if applicable during study period of one year
Title
Continuous Glucose Monitoring
Description
Continuous Glucose Monitoring via CGM-Device in subgroup
Time Frame
14 days after baseline
Title
Ketone bodies in breath
Description
Breath acetone, in subgroup
Time Frame
up to 4 days before, during and up to 7 days after fasting intervention
Title
Cumulative drug dose for ovulation induction
Description
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)

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
biological female sex
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Michalsen, Prof. Dr.
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
14109
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Feasibility and Safety of Fasting in Fertility Treatment

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