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Effects of Fasting on Success Rates of Assisted Reproductive Techologies

NCT ID: NCT04998591

Last Updated: 2022-12-14

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

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-03

Study Completion Date

2022-12-12

Brief Summary

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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

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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.

Conditions

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Sub Fertility, Female Fertility Disorders Fertility Issues Sub-fertility IVF

Keywords

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fasting natural therapies caloric restriction lifestyle modification dietary restriction dietary intervention complementary medicine integrative medicine Intracytoplasmatic sperm injection ICSI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
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 group

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

Group Type EXPERIMENTAL

Fasting

Intervention Type BEHAVIORAL

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

Waiting list

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fasting

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Prolonged Fasting

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

38 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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KiWuC

Identifier Type: -

Identifier Source: org_study_id