Effects of Fasting on Success Rates of Assisted Reproductive Techologies

IVF Clinical Trial

— KiWuC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04998591
• Other study ID #: KiWuC
• Status: Terminated
• Phase: N/A
• Start date: August 3, 2021
• Est. completion date: December 12, 2022

Study information

• Verified date: December 2022
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 12, 2022
• Est. primary completion date: December 12, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 38 Years

Eligibility

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

Related Conditions & MeSH terms

• Fertility Disorders
• Fertility Issues
• Infertility
• Infertility, Female
• IVF
• Sub-fertility

Intervention

Behavioral:
• Fasting
fasting for 7 days (caloric intake <500 kcal in liquid form)

Locations

Country	Name	City	State
Germany	Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Karl and Veronica Carstens Foundation

Country where clinical trial is conducted

Germany, 

Outcome

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