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Feasibility and Safety of Fasting in Fertility Treatment

NCT ID: NCT04942457

Last Updated: 2023-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-10

Study Completion Date

2023-12-20

Brief Summary

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

Detailed Description

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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.

Conditions

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Sub Fertility, Female Fertility Disorders Cycle Disorders Menstrual Ovulation Disorder Ovulation Absent Ovulation Delayed Ovulation; Failure or Lack of Sub-fertility

Keywords

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fasting natural therapies caloric restriction lifestyle modification dietary restriction dietary intervention prolonged fasting weight loss complementary medicine integrative medicine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

There are 2 parallel groups following different nutritional regimes. Additionally Qualitative Interviews with Patients and Doctors/Medical Staff.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
It is not possible to mask a fasting intervention for the participant or the study personel. Therefore only outcome assessors are masked.

Study Groups

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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).

Group Type EXPERIMENTAL

Fasting

Intervention Type BEHAVIORAL

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

Control group

waiting list, usual diet should be maintained

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fasting

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Karl and Veronica Carstens Foundation

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Andreas Michalsen

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Michalsen, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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KiWuA

Identifier Type: -

Identifier Source: org_study_id