Feasibility and Safety of Fasting in Fertility Treatment (KiWuA)

Charité University Medicine Berlin

Status: Completed

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

Treatments: Behavioral: Fasting

Study type: Interventional

Funder types: Other

Identifiers

NCT04942457

KiWuA

Details and patient eligibility

About

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

Full description

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.

Enrollment: 34 patients

Sex: Female

Ages: 25 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

34 participants in 2 patient groups

Fasting

Experimental group

Description:

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).

Treatment:

Behavioral: Fasting

Control group

No Intervention group

Description:

waiting list, usual diet should be maintained