Clinical trial NCT04998591: Effects of Fasting on Success Rates of Assisted Reproductive Techologies
Official title: Effects of Fasting on Success Rates of In-vitro-fertilization (IVF) / Intracytoplasmatic Sperm Injection (ICSI) in Women With Fertility Disorders
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sub Fertility, Female
Fertility Disorders
Fertility Issues
Sub-fertility
IVF
Keywords: fasting
natural therapies
caloric restriction
lifestyle modification
dietary restriction
dietary intervention
complementary medicine
integrative medicine
Intracytoplasmatic sperm injection ICSI
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Karl and Veronica Carstens Foundation
First posted: 2021-08-10
Enrollment: 1
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fertilisation rate
timeFrame: throughout 1-3 days after in-vitro-fertilization (IVF) / intracytoplasmatic sperm injection (ICSI)
Secondary outcomes:
measure: glucose in culture medium of oocytes
timeFrame: throughout 1-3 days after in vitro fertilisation
measure: lactate in culture medium of oocytes
timeFrame: throughout 1-3 days after in vitro fertilisation
measure: pyruvate in culture medium of oocytes
timeFrame: throughout 1-3 days after in vitro fertilisation
measure: pregnancy rate
timeFrame: 4 weeks after IVF/ICSI
measure: rate of mature oocytes
timeFrame: at IVF / ICSI intervention
measure: rate of life births
timeFrame: 10 months after IVF/ICSI
measure: rate of implantable embryos
timeFrame: at IVF/ICSI
measure: Course of IVF/ICSI preparation and pregnancy
timeFrame: 4 weeks and 10 months after IVF / ICSI
measure: WHO-5 questionnaire
timeFrame: baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
measure: changes in diet
timeFrame: baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
measure: mindfulness
timeFrame: baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
measure: anxiety and depression
timeFrame: baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
measure: current mood
timeFrame: baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
measure: experienced stress
timeFrame: baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
measure: physical fitness
timeFrame: baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
measure: quality of relationship
timeFrame: baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
measure: psychological stress caused by the unfulfilled desire to have children
timeFrame: baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
measure: gratitude
timeFrame: baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
measure: self-efficacy
timeFrame: baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline
measure: abdominal sonography
timeFrame: within 1 month before, during and within 2 weeks after the fasting intervention
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Andreas Michalsen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: