Feasibility and Safety of Fasting in Fertility Treatment

Fertility Disorders Clinical Trial

— KiWuA  

Official title:

Effects of Fasting in Fertility Treatment in Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04942457
• Other study ID #: KiWuA
• Status: Completed
• Phase: N/A
• Start date: January 10, 2022
• Est. completion date: December 20, 2023

Study information

• Verified date: December 2023
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 20, 2023
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Anovulation
• Fertility Disorders
• Infertility
• Infertility, Female
• Menstruation Disturbances
• Ovulation Disorder
• Ovulation; Failure or Lack of
• Sub-fertility

Intervention

Behavioral:
• Fasting
Prolonged fasting for 7-10 days (caloric intake <500 kcal in liquid form)

Locations

Country	Name	City	State
Germany	Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Karl and Veronica Carstens Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitative interview analysis of fasting experience	individual and focus group interviews	in time frame of 24 weeks after fasting intervention
Primary	pregancy rate	pregnancy rate of the participants	at baseline, after one month, at end of ovulation induction treatment (2-6 months) and 12 months after baseline
Secondary	complication rates in pregnancy	complication rates monitored by the gynaecologist, if applicable	12 months after baseline
Secondary	Hormonal status	FSH, LH, Estrogen, Progesteron	at the beginning and end of each ovulatory cycle, for up to 12 months
Secondary	HbA1c	serum parameter	baseline and at end of ovulation induction treatment (2-6 months), for up to 12 months
Secondary	WHO-5	Quality of life	at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
Secondary	diet	questionnaire to examine dietary behaviour	at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
Secondary	mindfulness	MAAS-questionnaire, validated questionnaire to examine mindfulness	at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
Secondary	anxiety and depression	HADS-questionnaire, validated questionnaire to examine anxiety and depression	at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
Secondary	current mood	ASTS-questionnaire, validated questionnaire to examine current mood	at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
Secondary	experienced stress	Cohen-stress scale, validated questionnaire to examine experienced stress	at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
Secondary	physical fitness	questionnaire to examine physical fitness	at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
Secondary	quality of relationship	questionnaire to examine the relationship between the two partners desiring to have a child	at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
Secondary	psychological stress caused by the unfulfilled desire to have children	questionnaire to examine the psychological stress caused by the unfulfilled desire to have children	at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
Secondary	gratitude	validated questionnaire to examine gratitude	at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
Secondary	self-efficacy	ASKU, validated questionnaire to examine self-efficacy	at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
Secondary	abdominal ultrasound after liver wrap	sonography in a subgroup	before, during and after the fasting intervention
Secondary	rate of ovulations	ovulation visible in sonography	at baseline, after one month, at end of ovulation induction treatment (2-6 months) and 12 months after baseline
Secondary	liver function parameters	serum liver enzymes	at baseline, after one month, at end of ovulation induction treatment (2-6 months), after 12 months
Secondary	pyruvate in culture medium of oocytes, if applicable (in case of IVF/ICSI)	chemical composition of culture medium (pyruvate)	after in vitro fertilisation, if applicable during study period of one year
Secondary	glucose in culture medium of oocytes, if applicable (in case of IVF/ICSI)	chemical composition of culture medium (glucose)	after in vitro fertilisation, if applicable during study period of one year
Secondary	lactate in culture medium of oocytes, if applicable (in case of IVF/ICSI)	chemical composition of culture medium (lactate)	after in vitro fertilisation, if applicable during study period of one year
Secondary	Continuous Glucose Monitoring	Continuous Glucose Monitoring via CGM-Device in subgroup	14 days after baseline
Secondary	Ketone bodies in breath	Breath acetone, in subgroup	up to 4 days before, during and up to 7 days after fasting intervention
Secondary	Cumulative drug dose for ovulation induction	Cumulative dosage of hormonal therapy for each assisted cycle of ovulation induction	baseline and until end of treatment for ovulation induction (2-6 months)