NCT04998591

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)

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

August 3, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 10, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2022

Completed
Last Updated

December 14, 2022

Status Verified

December 1, 2022

Enrollment Period

1.4 years

First QC Date

July 24, 2021

Last Update Submit

December 12, 2022

Conditions

Sub Fertility, FemaleFertility DisordersFertility IssuesSub-fertilityIVF

Keywords

fastingnatural therapiescaloric restrictionlifestyle modificationdietary restrictiondietary interventioncomplementary medicineintegrative medicineIntracytoplasmatic sperm injection ICSI

Outcome Measures

Primary Outcomes (1)

  • Fertilisation rate

    Fertilisation rate of the retrieved oocytes

    throughout 1-3 days after in-vitro-fertilization (IVF) / intracytoplasmatic sperm injection (ICSI)

Secondary Outcomes (20)

  • glucose in culture medium of oocytes

    throughout 1-3 days after in vitro fertilisation

  • lactate in culture medium of oocytes

    throughout 1-3 days after in vitro fertilisation

  • pyruvate in culture medium of oocytes

    throughout 1-3 days after in vitro fertilisation

  • pregnancy rate

    4 weeks after IVF/ICSI

  • rate of mature oocytes

    at IVF / ICSI intervention

  • +15 more secondary outcomes

Study Arms (2)

Fasting group

EXPERIMENTAL

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

Behavioral: Fasting

Waiting list

NO INTERVENTION

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.

Interventions

FastingBEHAVIORAL

fasting for 7 days (caloric intake \<500 kcal in liquid form)

Also known as: Prolonged Fasting
Fasting group

Eligibility Criteria

Age25 Years - 38 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsbiological female sex
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 25 to 38 years with planned IVF / ICSI
  • ng/ml ≤ Anti-Mullerian Hormone (AMH) ≤ 4 ng/ml
  • Unfulfilled desire to have children \>1 year
  • kg/m² ≤ BMI ≤ 35 kg/m² declaration of consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin

Berlin, 14109, Germany

Location

MeSH Terms

Conditions

Infertility, FemaleInfertilityFasting

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesFeeding BehaviorBehavior

Study Officials

  • Andreas Michalsen, Prof. Dr.

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
It is not possible to mask a fasting intervention for the participant or the study personel. Therefore only outcome assessors are masked.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

July 24, 2021

First Posted

August 10, 2021

Study Start

August 3, 2021

Primary Completion

December 12, 2022

Study Completion

December 12, 2022

Last Updated

December 14, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will share

Data will be made available upon request.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
after the end of the study for 5 years
Access Criteria
on demand

Locations

DE(1)