KiWuC: Effects of Fasting on Success Rates of Assisted Reproductive Techologies

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Recruiting

CT.gov ID

NCT04998591

Collaborator

Karl and Veronica Carstens Foundation (Other)

Enrollment

Location

Arms

15.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Sub Fertility, Female Fertility Disorders Fertility Issues Sub-fertility IVF	Behavioral: Fasting	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This explorative study is conducted in form of a randomized, controlled trial design with a fasting intervention and a waiting list, which continues the usual diet.This explorative study is conducted in form of a randomized, controlled trial design with a fasting intervention and a waiting list, which continues the usual diet.

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 Success Rates of In-vitro-fertilization (IVF) / Intracytoplasmatic Sperm Injection (ICSI) in Women With Fertility Disorders

Actual Study Start Date :

Aug 3, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fasting group Participants will be councelled and accompanied to follow a fasting regime of 7 days in an outpatient setting under medical supervision.	Behavioral: Fasting fasting for 7 days (caloric intake <500 kcal in liquid form) Other Names: Prolonged Fasting
No Intervention: Waiting list 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.

Arm

Intervention/Treatment

Experimental: Fasting group

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

Behavioral: Fasting

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

Other Names:

Prolonged Fasting

No Intervention: Waiting list

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.

Outcome Measures

Primary Outcome Measures

Fertilisation rate [throughout 1-3 days after in-vitro-fertilization (IVF) / intracytoplasmatic sperm injection (ICSI)]
Fertilisation rate of the retrieved oocytes

Secondary Outcome Measures

glucose in culture medium of oocytes [throughout 1-3 days after in vitro fertilisation]
chemical composition of culture medium (glucose)
lactate in culture medium of oocytes [throughout 1-3 days after in vitro fertilisation]
chemical composition of culture medium (lactate)
pyruvate in culture medium of oocytes [throughout 1-3 days after in vitro fertilisation]
chemical composition of culture medium (pyruvate)
pregnancy rate [4 weeks after IVF/ICSI]
pregnancies after IVF/ICSI
rate of mature oocytes [at IVF / ICSI intervention]
rate of mature oocytes
rate of life births [10 months after IVF/ICSI]
rate of life births after IVF/ICSI
rate of implantable embryos [at IVF/ICSI]
rate of implantable embryos after the IVF/ICSI
Course of IVF/ICSI preparation and pregnancy [4 weeks and 10 months after IVF / ICSI]
Course of IVF/ICSI preparation and pregnancy
WHO-5 questionnaire [baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline]
Quality of life
changes in diet [baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline]
self-developed questionnaire to examine dietary behaviour
mindfulness [baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline]
MAAS-questionnaire, validated questionnaire to examine mindfulness
anxiety and depression [baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline]
HADS-questionnaire, validated questionnaire to examine anxiety and depression
current mood [baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline]
ASTS-questionnaire, validated questionnaire to examine current mood
experienced stress [baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline]
Cohen-stress scale, validated questionnaire to examine experienced stress
physical fitness [baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline]
questionnaire to examine physical fitness
quality of relationship [baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline]
self-developed questionnaire to examine the relationship between the two partners desiring to have a child
psychological stress caused by the unfulfilled desire to have children [baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline]
self-developed questionnaire to examine the psychological stress caused by the unfulfilled desire to have children
gratitude [baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline]
validated questionnaire to examine gratitude
self-efficacy [baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline]
ASKU, validated questionnaire to examine self-efficacy
abdominal sonography [within 1 month before, during and within 2 weeks after the fasting intervention]
sonography in a subgroup