Fertility Disorders, Fertility Issues, IVF, Sub-fertility, Sub Fertility, Female
Conditions
Keywords
fasting, natural therapies, caloric restriction, lifestyle modification, dietary restriction, dietary intervention, complementary medicine, integrative medicine, Intracytoplasmatic sperm injection ICSI
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.
Interventions
BEHAVIORALFasting
fasting for 7 days (caloric intake \<500 kcal in liquid form)
Sponsors
Karl and Veronica Carstens Foundation
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
It is not possible to mask a fasting intervention for the participant or the study personel. Therefore only outcome assessors are masked.
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.
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 38 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fertilisation rate | throughout 1-3 days after in-vitro-fertilization (IVF) / intracytoplasmatic sperm injection (ICSI) | Fertilisation rate of the retrieved oocytes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| lactate in culture medium of oocytes | throughout 1-3 days after in vitro fertilisation | chemical composition of culture medium (lactate) |
| pyruvate in culture medium of oocytes | throughout 1-3 days after in vitro fertilisation | chemical composition of culture medium (pyruvate) |
| pregnancy rate | 4 weeks after IVF/ICSI | pregnancies after IVF/ICSI |
| rate of mature oocytes | at IVF / ICSI intervention | rate of mature oocytes |
| rate of life births | 10 months after IVF/ICSI | rate of life births after IVF/ICSI |
| rate of implantable embryos | at IVF/ICSI | rate of implantable embryos after the IVF/ICSI |
| Course of IVF/ICSI preparation and pregnancy | 4 weeks and 10 months after IVF / ICSI | Course of IVF/ICSI preparation and pregnancy |
| WHO-5 questionnaire | baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline | Quality of life |
| changes in diet | baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline | self-developed questionnaire to examine dietary behaviour |
| glucose in culture medium of oocytes | throughout 1-3 days after in vitro fertilisation | chemical composition of culture medium (glucose) |
| 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 |
| 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 |
| 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 |
| gratitude | baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline | validated questionnaire to examine gratitude |
| self-efficacy | baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline | ASKU, validated questionnaire to examine self-efficacy |
| abdominal sonography | within 1 month before, during and within 2 weeks after the fasting intervention | sonography in a subgroup |
| mindfulness | baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline | MAAS-questionnaire, validated questionnaire to examine mindfulness |
Countries
Germany
Outcome results
None listed