Effects of Fasting on Success Rates of Assisted Reproductive Techologies

Not Applicable

Terminated

• Conditions: Fertility Issues; Sub Fertility, Female; Fertility Disorders; IVF; Sub-fertility

• Registration Number: NCT04998591
• Lead Sponsor: Charite University, Berlin, Germany

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)

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 Timeline

• Study First Submitted: 2021-07-24
• Study Start: 2021-08-03
• Study First Submitted QC: 2021-08-03
• Study First Posted: 2021-08-10
• Status Verified: 2022-12
• Primary Completion: 2022-12-12
• Study Completion: 2022-12-12
• Last Update Submitted: 2022-12-12
• Last Update Posted: 2022-12-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 1

Inclusion Criteria

• Women aged 25 to 38 years with planned IVF / ICSI
• 1 ng/ml ≤ Anti-Mullerian Hormone (AMH) ≤ 4 ng/ml
• Unfulfilled desire to have children >1 year
• 25 kg/m² ≤ BMI ≤ 35 kg/m² declaration of consent

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
pregnancy rate	4 weeks after IVF/ICSI	pregnancies after IVF/ICSI
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)
rate of implantable embryos	at IVF/ICSI	rate of implantable embryos after the IVF/ICSI
rate of life births	10 months after IVF/ICSI	rate of life births after IVF/ICSI
WHO-5 questionnaire	baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline	Quality of life
mindfulness	baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline	MAAS-questionnaire, validated questionnaire to examine mindfulness
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
Course of IVF/ICSI preparation and pregnancy	4 weeks and 10 months after IVF / ICSI	Course of IVF/ICSI preparation and pregnancy
changes in diet	baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline	self-developed questionnaire to examine dietary behaviour
gratitude	baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline	validated questionnaire to examine gratitude
abdominal sonography	within 1 month before, during and within 2 weeks after the fasting intervention	sonography in a subgroup
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
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
self-efficacy	baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline	ASKU, validated questionnaire to examine self-efficacy
rate of mature oocytes	at IVF / ICSI intervention	rate of mature oocytes
pyruvate in culture medium of oocytes	throughout 1-3 days after in vitro fertilisation	chemical composition of culture medium (pyruvate)

Trial Locations

Locations (1)

Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany