This exploratory study investigates fasting as a potential supportive therapy for infertility treatment in women undergoing in-vitro-fertilization (IVF) / intracystoplamsatic sperm injection (ICSI)
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1
fasting for 7 days (caloric intake \<500 kcal in liquid form)
Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin
Berlin, Germany
Fertilisation rate
Fertilisation rate of the retrieved oocytes
Time frame: throughout 1-3 days after in-vitro-fertilization (IVF) / intracytoplasmatic sperm injection (ICSI)
glucose in culture medium of oocytes
chemical composition of culture medium (glucose)
Time frame: throughout 1-3 days after in vitro fertilisation
lactate in culture medium of oocytes
chemical composition of culture medium (lactate)
Time frame: throughout 1-3 days after in vitro fertilisation
pyruvate in culture medium of oocytes
chemical composition of culture medium (pyruvate)
Time frame: throughout 1-3 days after in vitro fertilisation
pregnancy rate
pregnancies after IVF/ICSI
Time frame: 4 weeks after IVF/ICSI
rate of mature oocytes
rate of mature oocytes
Time frame: at IVF / ICSI intervention
rate of life births
rate of life births after IVF/ICSI
Time frame: 10 months after IVF/ICSI
rate of implantable embryos
rate of implantable embryos after the IVF/ICSI
Time frame: at IVF/ICSI
Course of IVF/ICSI preparation and pregnancy
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Course of IVF/ICSI preparation and pregnancy
Time frame: 4 weeks and 10 months after IVF / ICSI
WHO-5 questionnaire
Quality of life
Time frame: baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
changes in diet
self-developed questionnaire to examine dietary behaviour
Time frame: baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
mindfulness
MAAS-questionnaire, validated questionnaire to examine mindfulness
Time frame: baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
anxiety and depression
HADS-questionnaire, validated questionnaire to examine anxiety and depression
Time frame: baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
current mood
ASTS-questionnaire, validated questionnaire to examine current mood
Time frame: baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
experienced stress
Cohen-stress scale, validated questionnaire to examine experienced stress
Time frame: baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
physical fitness
questionnaire to examine physical fitness
Time frame: baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
quality of relationship
self-developed questionnaire to examine the relationship between the two partners desiring to have a child
Time frame: baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
psychological stress caused by the unfulfilled desire to have children
self-developed questionnaire to examine the psychological stress caused by the unfulfilled desire to have children
Time frame: baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
gratitude
validated questionnaire to examine gratitude
Time frame: baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
self-efficacy
ASKU, validated questionnaire to examine self-efficacy
Time frame: baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
abdominal sonography
sonography in a subgroup
Time frame: within 1 month before, during and within 2 weeks after the fasting intervention