KiWuA: Efficacy of Fasting on Hormone Dosage in Fertility Treatment

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Recruiting

CT.gov ID

NCT04942457

Collaborator

Karl and Veronica Carstens Foundation (Other)

Enrollment

Location

Arms

34.7

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Sub Fertility, Female Fertility Disorders Cycle Disorders Menstrual Ovulation Disorder Ovulation Absent Ovulation Delayed Ovulation; Failure or Lack of Sub-fertility	Behavioral: Fasting	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

There are 2 parallel groups following different nutritional regimes.There are 2 parallel groups following different nutritional regimes.

Masking:

Single (Outcomes Assessor)

Masking Description:

It is not possible to mask a fasting intervention for the participant or the study personel. Therefore only outcome assessors are masked.

Primary Purpose:

Treatment

Official Title:

Effects of Fasting on Hormone Dosage in Fertility Treatment in Women With Ovulation Disorders

Actual Study Start Date :

Jan 10, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fasting Participants will be councelled and accompanied to follow a prolonged fasting regime of 7-10 days in an outpatient setting under medical supervision.	Behavioral: Fasting Prolonged fasting for 7-10 days (caloric intake <500 kcal in liquid form)
No Intervention: Control group waiting list, usual diet should be maintained

Arm

Intervention/Treatment

Experimental: Fasting

Participants will be councelled and accompanied to follow a prolonged fasting regime of 7-10 days in an outpatient setting under medical supervision.

Behavioral: Fasting

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

No Intervention: Control group

waiting list, usual diet should be maintained

Outcome Measures

Primary Outcome Measures

Qualitative interview analysis of fasting experience [in time frame of 24 weeks after fasting intervention]
individual and focus group interviews
pregancy rate [at baseline, after one month, at end of ovulation induction treatment (2-6 months) and 12 months after baseline]
pregnancy rate of the participants

Secondary Outcome Measures

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