Clinical trial NCT04942457: Feasibility and Safety of Fasting in Fertility Treatment
Official title: Effects of Fasting in Fertility Treatment in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Karl and Veronica Carstens Foundation
First posted: 2021-06-28
Enrollment: 34
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are 2 parallel groups following different nutritional regimes. Additionally Qualitative Interviews with Patients and Doctors/Medical Staff.
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Qualitative interview analysis of fasting experience
timeFrame: in time frame of 24 weeks after fasting intervention
measure: pregancy rate
timeFrame: at baseline, after one month, at end of ovulation induction treatment (2-6 months) and 12 months after baseline
Secondary outcomes:
measure: complication rates in pregnancy
timeFrame: 12 months after baseline
measure: Hormonal status
timeFrame: at the beginning and end of each ovulatory cycle, for up to 12 months
measure: HbA1c
timeFrame: baseline and at end of ovulation induction treatment (2-6 months), for up to 12 months
measure: WHO-5
timeFrame: at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
measure: diet
timeFrame: at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
measure: mindfulness
timeFrame: at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
measure: anxiety and depression
timeFrame: at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
measure: current mood
timeFrame: at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
measure: experienced stress
timeFrame: at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
measure: physical fitness
timeFrame: at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
measure: quality of relationship
timeFrame: at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
measure: psychological stress caused by the unfulfilled desire to have children
timeFrame: at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
measure: gratitude
timeFrame: at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
measure: self-efficacy
timeFrame: at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
measure: abdominal ultrasound after liver wrap
timeFrame: before, during and after the fasting intervention
measure: rate of ovulations
timeFrame: at baseline, after one month, at end of ovulation induction treatment (2-6 months) and 12 months after baseline
measure: liver function parameters
timeFrame: at baseline, after one month, at end of ovulation induction treatment (2-6 months), after 12 months
measure: pyruvate in culture medium of oocytes, if applicable (in case of IVF/ICSI)
timeFrame: after in vitro fertilisation, if applicable during study period of one year
measure: glucose in culture medium of oocytes, if applicable (in case of IVF/ICSI)
timeFrame: after in vitro fertilisation, if applicable during study period of one year
measure: lactate in culture medium of oocytes, if applicable (in case of IVF/ICSI)
timeFrame: after in vitro fertilisation, if applicable during study period of one year
measure: Continuous Glucose Monitoring
timeFrame: 14 days after baseline
measure: Ketone bodies in breath
timeFrame: up to 4 days before, during and up to 7 days after fasting intervention
measure: Cumulative drug dose for ovulation induction
timeFrame: baseline and until end of treatment for ovulation induction (2-6 months)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Andreas Michalsen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: