Effects of Fasting on Success Rates of Assisted Reproductive Techologies

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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IVF, Sub Fertility, Female, Fertility Disorders, Fertility Issues, Sub-fertility

Intervention / Treatment
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* Behavioral: Fasting


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fasting group<br>Participants will be councelled and accompanied to follow a fasting regime of 7 days in an outpatient setting under medical supervision. | Behavioral: Fasting<br>* fasting for 7 days (caloric intake <500 kcal in liquid form)<br>* Other names: Prolonged Fasting;|
| No Intervention: Waiting list<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fertilisation rate | Fertilisation rate of the retrieved oocytes | throughout 1-3 days after in-vitro-fertilization (IVF) / intracytoplasmatic sperm injection (ICSI) | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fasting, natural therapies, caloric restriction, lifestyle modification, dietary restriction, dietary intervention, complementary medicine, integrative medicine, Intracytoplasmatic sperm injection ICSI