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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 in infertility treatment for women suffering from infertility
This 2-arm, randomized, controlled exploratory clinical trial aims to explore fasting as a novel supportive treatment in infertility. The participants will be randomized in two groups: fasting and waiting list. All groups will be trained and accompanied by medical experts and dieticians. 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 | Experimental | Participants will be councelled and accompanied to follow a prolonged fasting regime of 7-10 days in an outpatient setting under medical supervision. Additionally qualitative interviews will be conducted by few participants in the experimental arm, as well as their respective Healthcare Providers (Doctors/Medical Staff). |
|
| Control group | No Intervention | waiting list, usual diet should be maintained |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fasting | Behavioral | Prolonged fasting for 7-10 days (caloric intake <500 kcal in liquid form) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative interview analysis of fasting experience | individual and focus group interviews | in time frame of 24 weeks after fasting intervention |
| pregancy rate | pregnancy rate of the participants | at baseline, after one month, at end of ovulation induction treatment (2-6 months) and 12 months after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| complication rates in pregnancy | complication rates monitored by the gynaecologist, if applicable | 12 months after baseline |
| Hormonal status | FSH, LH, Estrogen, Progesteron |
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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 |
| D008599 | Menstruation Disturbances |
| D000858 | Anovulation |
| D007246 | Infertility |
| D005215 | Fasting |
| D015431 | Weight Loss |
| 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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There are 2 parallel groups following different nutritional regimes. Additionally Qualitative Interviews with Patients and Doctors/Medical Staff.
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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.
| at the beginning and end of each ovulatory cycle, for up to 12 months |
| HbA1c | serum parameter | baseline and at end of ovulation induction treatment (2-6 months), for up to 12 months |
| WHO-5 | Quality of life | at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline |
| diet | questionnaire to examine dietary behaviour | at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline |
| mindfulness | MAAS-questionnaire, validated questionnaire to examine mindfulness | at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline |
| anxiety and depression | HADS-questionnaire, validated questionnaire to examine anxiety and depression | at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline |
| current mood | ASTS-questionnaire, validated questionnaire to examine current mood | at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline |
| experienced stress | Cohen-stress scale, validated questionnaire to examine experienced stress | at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline |
| physical fitness | questionnaire to examine physical fitness | at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline |
| quality of relationship | questionnaire to examine the relationship between the two partners desiring to have a child | at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline |
| psychological stress caused by the unfulfilled desire to have children | questionnaire to examine the psychological stress caused by the unfulfilled desire to have children | at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline |
| gratitude | validated questionnaire to examine gratitude | at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline |
| self-efficacy | ASKU, validated questionnaire to examine self-efficacy | at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline |
| abdominal ultrasound after liver wrap | sonography in a subgroup | before, during and after the fasting intervention |
| rate of ovulations | ovulation visible in sonography | at baseline, after one month, at end of ovulation induction treatment (2-6 months) and 12 months after baseline |
| liver function parameters | serum liver enzymes | at baseline, after one month, at end of ovulation induction treatment (2-6 months), after 12 months |
| pyruvate in culture medium of oocytes, if applicable (in case of IVF/ICSI) | chemical composition of culture medium (pyruvate) | after in vitro fertilisation, if applicable during study period of one year |
| glucose in culture medium of oocytes, if applicable (in case of IVF/ICSI) | chemical composition of culture medium (glucose) | after in vitro fertilisation, if applicable during study period of one year |
| lactate in culture medium of oocytes, if applicable (in case of IVF/ICSI) | chemical composition of culture medium (lactate) | after in vitro fertilisation, if applicable during study period of one year |
| Continuous Glucose Monitoring | Continuous Glucose Monitoring via CGM-Device in subgroup | 14 days after baseline |
| Ketone bodies in breath | Breath acetone, in subgroup | up to 4 days before, during and up to 7 days after fasting intervention |
| Cumulative drug dose for ovulation induction | Cumulative dosage of hormonal therapy for each assisted cycle of ovulation induction | baseline and until end of treatment for ovulation induction (2-6 months) |
| D000091662 | Genital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |