Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-30 @ 4:52 AM
Study NCT ID:
NCT04942457
Status:
COMPLETED
Last Update Posted:
2023-12-29
First Post:
2021-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility and Safety of Fasting in Fertility Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}, {'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D000858', 'term': 'Anovulation'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D005215', 'term': 'Fasting'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C407088', 'term': 'Angptl4 protein, mouse'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'It is not possible to mask a fasting intervention for the participant or the study personel. Therefore only outcome assessors are masked.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There are 2 parallel groups following different nutritional regimes. Additionally Qualitative Interviews with Patients and Doctors/Medical Staff.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-28', 'studyFirstSubmitDate': '2021-05-10', 'studyFirstSubmitQcDate': '2021-06-25', 'lastUpdatePostDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Qualitative interview analysis of fasting experience', 'timeFrame': 'in time frame of 24 weeks after fasting intervention', 'description': 'individual and focus group interviews'}, {'measure': 'pregancy rate', 'timeFrame': 'at baseline, after one month, at end of ovulation induction treatment (2-6 months) and 12 months after baseline', 'description': 'pregnancy rate of the participants'}], 'secondaryOutcomes': [{'measure': 'complication rates in pregnancy', 'timeFrame': '12 months after baseline', 'description': 'complication rates monitored by the gynaecologist, if applicable'}, {'measure': 'Hormonal status', 'timeFrame': 'at the beginning and end of each ovulatory cycle, for up to 12 months', 'description': 'FSH, LH, Estrogen, Progesteron'}, {'measure': 'HbA1c', 'timeFrame': 'baseline and at end of ovulation induction treatment (2-6 months), for up to 12 months', 'description': 'serum parameter'}, {'measure': 'WHO-5', 'timeFrame': 'at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline', 'description': 'Quality of life'}, {'measure': 'diet', 'timeFrame': 'at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline', 'description': 'questionnaire to examine dietary behaviour'}, {'measure': 'mindfulness', 'timeFrame': 'at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline', 'description': 'MAAS-questionnaire, validated questionnaire to examine mindfulness'}, {'measure': 'anxiety and depression', 'timeFrame': 'at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline', 'description': 'HADS-questionnaire, validated questionnaire to examine anxiety and depression'}, {'measure': 'current mood', 'timeFrame': 'at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline', 'description': 'ASTS-questionnaire, validated questionnaire to examine current mood'}, {'measure': 'experienced stress', 'timeFrame': 'at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline', 'description': 'Cohen-stress scale, validated questionnaire to examine experienced stress'}, {'measure': 'physical fitness', 'timeFrame': 'at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline', 'description': 'questionnaire to examine physical fitness'}, {'measure': 'quality of relationship', 'timeFrame': 'at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline', 'description': 'questionnaire to examine the relationship between the two partners desiring to have a child'}, {'measure': 'psychological stress caused by the unfulfilled desire to have children', 'timeFrame': 'at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline', 'description': 'questionnaire to examine the psychological stress caused by the unfulfilled desire to have children'}, {'measure': 'gratitude', 'timeFrame': 'at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline', 'description': 'validated questionnaire to examine gratitude'}, {'measure': 'self-efficacy', 'timeFrame': 'at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline', 'description': 'ASKU, validated questionnaire to examine self-efficacy'}, {'measure': 'abdominal ultrasound after liver wrap', 'timeFrame': 'before, during and after the fasting intervention', 'description': 'sonography in a subgroup'}, {'measure': 'rate of ovulations', 'timeFrame': 'at baseline, after one month, at end of ovulation induction treatment (2-6 months) and 12 months after baseline', 'description': 'ovulation visible in sonography'}, {'measure': 'liver function parameters', 'timeFrame': 'at baseline, after one month, at end of ovulation induction treatment (2-6 months), after 12 months', 'description': 'serum liver enzymes'}, {'measure': 'pyruvate in culture medium of oocytes, if applicable (in case of IVF/ICSI)', 'timeFrame': 'after in vitro fertilisation, if applicable during study period of one year', 'description': 'chemical composition of culture medium (pyruvate)'}, {'measure': 'glucose in culture medium of oocytes, if applicable (in case of IVF/ICSI)', 'timeFrame': 'after in vitro fertilisation, if applicable during study period of one year', 'description': 'chemical composition of culture medium (glucose)'}, {'measure': 'lactate in culture medium of oocytes, if applicable (in case of IVF/ICSI)', 'timeFrame': 'after in vitro fertilisation, if applicable during study period of one year', 'description': 'chemical composition of culture medium (lactate)'}, {'measure': 'Continuous Glucose Monitoring', 'timeFrame': '14 days after baseline', 'description': 'Continuous Glucose Monitoring via CGM-Device in subgroup'}, {'measure': 'Ketone bodies in breath', 'timeFrame': 'up to 4 days before, during and up to 7 days after fasting intervention', 'description': 'Breath acetone, in subgroup'}, {'measure': 'Cumulative drug dose for ovulation induction', 'timeFrame': 'baseline and until end of treatment for ovulation induction (2-6 months)', 'description': 'Cumulative dosage of hormonal therapy for each assisted cycle of ovulation induction'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fasting', 'natural therapies', 'caloric restriction', 'lifestyle modification', 'dietary restriction', 'dietary intervention', 'prolonged fasting', 'weight loss', 'complementary medicine', 'integrative medicine'], 'conditions': ['Sub Fertility, Female', 'Fertility Disorders', 'Cycle Disorders Menstrual', 'Ovulation Disorder', 'Ovulation Absent', 'Ovulation Delayed', 'Ovulation; Failure or Lack of', 'Sub-fertility']}, 'descriptionModule': {'briefSummary': 'This exploratory study investigates fasting as a potential supportive therapy in infertility treatment for women suffering from infertility', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '25 Years', 'genderBased': True, 'genderDescription': 'biological female sex', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 25 to 45 years\n* Unfulfilled desire to have children \\>1 year\n* declaration of consent\n* 20 kg/m² ≤ BMI ≤ 40 kg/m²\n\nExclusion Criteria:\n\n* Language barriers\n* Previously known serious mental illness or cognitive impairment\n* Patients with anatomical/organic damage and proven uterine abnormalities\n* Eating disorders in the medical history\n* Serious previous internal diseases\n* Lack of internet access\n* No consent to randomisation\n* Participation in other studies'}, 'identificationModule': {'nctId': 'NCT04942457', 'acronym': 'KiWuA', 'briefTitle': 'Feasibility and Safety of Fasting in Fertility Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Effects of Fasting in Fertility Treatment in Women', 'orgStudyIdInfo': {'id': 'KiWuA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fasting', 'description': '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).', 'interventionNames': ['Behavioral: Fasting']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'waiting list, usual diet should be maintained'}], 'interventions': [{'name': 'Fasting', 'type': 'BEHAVIORAL', 'description': 'Prolonged fasting for 7-10 days (caloric intake \\<500 kcal in liquid form)', 'armGroupLabels': ['Fasting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14109', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Andreas Michalsen, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'after the end of the study for 5 years', 'ipdSharing': 'YES', 'description': 'Data will be made available upon request.', 'accessCriteria': 'on demand.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'Karl and Veronica Carstens Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med.', 'investigatorFullName': 'Andreas Michalsen', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}