An interventional study of Fasting in Sub Fertility, Female, Fertility Disorders and Fertility Issues, sponsored by Charite University, Berlin, Germany. Terminated at 1 site in Germany. Open to female participants aged 25 Years to 38 Years. Per ClinicalTrials.gov, last updated 2022-12-14.
Sponsored by Charite University, Berlin, Germany · Not applicable, Interventional, and Treatment
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.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's enrollment of 1 is below the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will be councelled and accompanied to follow a fasting regime of 7 days in an outpatient setting under medical supervision.
Behavioral: Fasting
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.
fasting for 7 days (caloric intake \<500 kcal in liquid form)
Also known as: Prolonged Fasting
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
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
Plan to share: Yes — Data will be made available upon request.
Supporting information: Study protocol, Sap, Icf, Analytic code
No publications or documents are linked to this record.
This study is terminated, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Charite University, Berlin, Germany