Feasibility and Safety of Fasting in Fertility Treatment

NCT04942457 | Completed DMC

• 1 other identifier: KiWuA
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Qualitative interview analysis of fasting experience

  individual and focus group interviews

  in time frame of 24 weeks after fasting intervention

• pregancy rate

  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 Outcomes (23)

• complication rates in pregnancy

  12 months after baseline

• Hormonal status

  at the beginning and end of each ovulatory cycle, for up to 12 months

• HbA1c

  baseline and at end of ovulation induction treatment (2-6 months), for up to 12 months

• WHO-5

  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

  at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline

Study Arms (2)

Fasting

EXPERIMENTAL

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

Control group

NO INTERVENTION

waiting list, usual diet should be maintained

Interventions

Fasting BEHAVIORAL

Prolonged fasting for 7-10 days (caloric intake \<500 kcal in liquid form)

Fasting

Eligibility Criteria

• Age: 25 Years - 45 Years
• Gender Eligibility Details: biological female sex
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 25 to 45 years
• Unfulfilled desire to have children \>1 year
• declaration of consent
• kg/m² ≤ BMI ≤ 40 kg/m²

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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Karl and Veronica Carstens Foundation: collaborator

Study Sites (1)

Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin

Berlin, 14109, Germany

Location

MeSH Terms

Conditions

Infertility, Female; Menstruation Disturbances; Anovulation; Infertility; Fasting; Weight Loss

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine System Diseases; Feeding Behavior; Behavior; Body Weight Changes; Body Weight; Signs and Symptoms

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
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Model Details: There are 2 parallel groups following different nutritional regimes. Additionally Qualitative Interviews with Patients and Doctors/Medical Staff.

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: June 28, 2021
• Study Start: January 10, 2022
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2023
• Last Updated: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• 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)