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

Charité University Medicine Berlin

Status: Terminated

Conditions: Fertility Disorders; IVF; Sub-fertility; Sub Fertility, Female; Fertility Issues

Treatments: Behavioral: Fasting

Study type: Interventional

Funder types: Other

Identifiers

NCT04998591

KiWuC

Details and patient eligibility

About

This exploratory study investigates fasting as a potential supportive therapy for infertility treatment in women undergoing in-vitro-fertilization (IVF) / intracystoplamsatic sperm injection (ICSI)

Full 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.

Enrollment: 1 patient

Sex: Female

Ages: 25 to 38 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1 participants in 2 patient groups

Fasting group

Experimental group

Description:

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

Treatment:

Behavioral: Fasting

Waiting list

No Intervention group

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.