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

Primary Purpose

Sub Fertility, Female, Fertility Disorders, Fertility Issues

Status
Terminated
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, complementary medicine, integrative medicine, Intracytoplasmatic sperm injection ICSI

Eligibility Criteria

25 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

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

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 group

Waiting list

Arm Description

Participants will be councelled and accompanied to follow a fasting regime of 7 days in an outpatient setting under medical supervision.

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.

Outcomes

Primary Outcome Measures

Fertilisation rate
Fertilisation rate of the retrieved oocytes

Secondary Outcome Measures

glucose in culture medium of oocytes
chemical composition of culture medium (glucose)
lactate in culture medium of oocytes
chemical composition of culture medium (lactate)
pyruvate in culture medium of oocytes
chemical composition of culture medium (pyruvate)
pregnancy rate
pregnancies after IVF/ICSI
rate of mature oocytes
rate of mature oocytes
rate of life births
rate of life births after IVF/ICSI
rate of implantable embryos
rate of implantable embryos after the IVF/ICSI
Course of IVF/ICSI preparation and pregnancy
Course of IVF/ICSI preparation and pregnancy
WHO-5 questionnaire
Quality of life
changes in diet
self-developed 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
self-developed questionnaire to examine the relationship between the two partners desiring to have a child
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
gratitude
validated questionnaire to examine gratitude
self-efficacy
ASKU, validated questionnaire to examine self-efficacy
abdominal sonography
sonography in a subgroup

Full Information

First Posted
July 24, 2021
Last Updated
December 12, 2022
Sponsor
Charite University, Berlin, Germany
Collaborators
Karl and Veronica Carstens Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04998591
Brief Title
Effects of Fasting on Success Rates of Assisted Reproductive Techologies
Acronym
KiWuC
Official Title
Effects of Fasting on Success Rates of In-vitro-fertilization (IVF) / Intracytoplasmatic Sperm Injection (ICSI) in Women With Fertility Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
Recruitment difficulties
Study Start Date
August 3, 2021 (Actual)
Primary Completion Date
December 12, 2022 (Actual)
Study Completion Date
December 12, 2022 (Actual)

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 for infertility treatment in women undergoing in-vitro-fertilization (IVF) / intracystoplamsatic sperm injection (ICSI)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sub Fertility, Female, Fertility Disorders, Fertility Issues, Sub-fertility, IVF
Keywords
fasting, natural therapies, caloric restriction, lifestyle modification, dietary restriction, dietary intervention, complementary medicine, integrative medicine, Intracytoplasmatic sperm injection ICSI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This explorative study is conducted in form of a randomized, controlled trial design with a fasting intervention and a waiting list, which continues the usual diet.
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
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fasting group
Arm Type
Experimental
Arm Description
Participants will be councelled and accompanied to follow a fasting regime of 7 days in an outpatient setting under medical supervision.
Arm Title
Waiting list
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Fasting
Other Intervention Name(s)
Prolonged Fasting
Intervention Description
fasting for 7 days (caloric intake <500 kcal in liquid form)
Primary Outcome Measure Information:
Title
Fertilisation rate
Description
Fertilisation rate of the retrieved oocytes
Time Frame
throughout 1-3 days after in-vitro-fertilization (IVF) / intracytoplasmatic sperm injection (ICSI)
Secondary Outcome Measure Information:
Title
glucose in culture medium of oocytes
Description
chemical composition of culture medium (glucose)
Time Frame
throughout 1-3 days after in vitro fertilisation
Title
lactate in culture medium of oocytes
Description
chemical composition of culture medium (lactate)
Time Frame
throughout 1-3 days after in vitro fertilisation
Title
pyruvate in culture medium of oocytes
Description
chemical composition of culture medium (pyruvate)
Time Frame
throughout 1-3 days after in vitro fertilisation
Title
pregnancy rate
Description
pregnancies after IVF/ICSI
Time Frame
4 weeks after IVF/ICSI
Title
rate of mature oocytes
Description
rate of mature oocytes
Time Frame
at IVF / ICSI intervention
Title
rate of life births
Description
rate of life births after IVF/ICSI
Time Frame
10 months after IVF/ICSI
Title
rate of implantable embryos
Description
rate of implantable embryos after the IVF/ICSI
Time Frame
at IVF/ICSI
Title
Course of IVF/ICSI preparation and pregnancy
Description
Course of IVF/ICSI preparation and pregnancy
Time Frame
4 weeks and 10 months after IVF / ICSI
Title
WHO-5 questionnaire
Description
Quality of life
Time Frame
baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
Title
changes in diet
Description
self-developed questionnaire to examine dietary behaviour
Time Frame
baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
Title
mindfulness
Description
MAAS-questionnaire, validated questionnaire to examine mindfulness
Time Frame
baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
Title
anxiety and depression
Description
HADS-questionnaire, validated questionnaire to examine anxiety and depression
Time Frame
baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
Title
current mood
Description
ASTS-questionnaire, validated questionnaire to examine current mood
Time Frame
baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
Title
experienced stress
Description
Cohen-stress scale, validated questionnaire to examine experienced stress
Time Frame
baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
Title
physical fitness
Description
questionnaire to examine physical fitness
Time Frame
baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
Title
quality of relationship
Description
self-developed questionnaire to examine the relationship between the two partners desiring to have a child
Time Frame
baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
Title
psychological stress caused by the unfulfilled desire to have children
Description
self-developed questionnaire to examine the psychological stress caused by the unfulfilled desire to have children
Time Frame
baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
Title
gratitude
Description
validated questionnaire to examine gratitude
Time Frame
baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
Title
self-efficacy
Description
ASKU, validated questionnaire to examine self-efficacy
Time Frame
baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
Title
abdominal sonography
Description
sonography in a subgroup
Time Frame
within 1 month before, during and within 2 weeks after the fasting intervention

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
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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

Effects of Fasting on Success Rates of Assisted Reproductive Techologies

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