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Recruitment difficulties
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| Name | Class |
|---|---|
| Karl and Veronica Carstens Foundation | OTHER |
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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasting group | Experimental | Participants will be councelled and accompanied to follow a fasting regime of 7 days in an outpatient setting under medical supervision. |
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| Waiting list | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fasting | Behavioral | fasting for 7 days (caloric intake <500 kcal in liquid form) |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
biological female sex
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Michalsen, Prof. Dr. | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin | Berlin | 14109 | Germany |
Data will be made available upon request.
after the end of the study for 5 years
on demand
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| D007246 | Infertility |
| D005215 | Fasting |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C407088 | Angptl4 protein, mouse |
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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.
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It is not possible to mask a fasting intervention for the participant or the study personel. Therefore only outcome assessors are masked.
| 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 |
| D000091662 | Genital Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |