Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-31 @ 5:03 AM
Study NCT ID:
NCT06666933
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-10-31
First Post:
2024-10-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Time-restricted Eating (TRE) to Clinical Pregnancy Rate in PCOS Women With Glucose Metabolism Disorder Via IVF/ICSI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D000093763', 'term': 'Intermittent Fasting'}], 'ancestors': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D005215', 'term': 'Fasting'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 254}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-28', 'studyFirstSubmitDate': '2024-10-20', 'studyFirstSubmitQcDate': '2024-10-28', 'lastUpdatePostDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical pregnancy rate for the first embryo transfer', 'timeFrame': '4-5 weeks after the IVF/ ICSI carried out at the end of the 6 weeks intervention', 'description': 'Clinical pregnancy rate= (number of cycle for 1or more gestational sac is observed via transvaginal ultrasound/ total number of cycle for first embryo transfer)x100%'}], 'secondaryOutcomes': [{'measure': 'Number of retrieved oocytes', 'timeFrame': 'After the IVF/ ICSI carried out at the end of the 6 weeks intervention', 'description': 'Includes immature oocytes, mature oocytes and abnormal oocytes from ovum pick-up'}, {'measure': 'Implantation rate', 'timeFrame': 'After the IVF/ ICSI carried out at the end of the 6 weeks intervention', 'description': 'the ration of total number of early gestational sacs to total number of transferred embryos'}, {'measure': 'Abortion rate', 'timeFrame': 'After the IVF/ ICSI carried out at the end of the 6 weeks intervention', 'description': 'the ratio of the number of nonviable pregnancies before 28 weeks of gestation to the number of clinical pregnancies'}, {'measure': 'Number of good quality embryo', 'timeFrame': 'After the IVF/ ICSI carried out at the end of the 6 weeks intervention', 'description': 'Day 3 embryo with 7-9 cells and \\<10% fragmentation'}, {'measure': 'Weight', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'Weight change in kg'}, {'measure': 'Fat%', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'Inbody machine measurement'}, {'measure': 'Lipid profile', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'Triglycerol, total cholesterol, HDL, LDL, free fatty acid in mmol/L'}, {'measure': 'Blood pressure', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'Both systolic and diastolic pressure in mmHg'}, {'measure': 'Sex hormone', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'DHEAs, testosterone, androstadienone, estradiol, LH, FSH, progesterone, prolactin, SHBG'}, {'measure': 'OGTT', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'Blood glucose level at 0h, 1h, 2h in mmol/L'}, {'measure': 'Insulin stimulation', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'Serum insulin level at 0h, 1h, 2h in ng/ml'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PCOS', 'Glucose Metabolism Disorder', 'IVF', 'ICSI', 'time-restricted eating'], 'conditions': ['PCOS', 'Glucose Metabolism Disorder', 'IVF Outcome']}, 'descriptionModule': {'briefSummary': 'Investigate the effect and mechanism of time-restricted eating (TRE) on the clinical pregnancy rate in women with PCOS and glucose metabolism disorder via IVF/ ICSI.', 'detailedDescription': 'In this multicenter randomized controlled study, investigators plan to recruit 254 patients, aged 20-38, with PCOS and glucose metabolism disorder. PCOS diagnostic criteria based on Rotterdam 2003 criteria, glucose metabolism disorder are diagnosed by 1998 WHO diagnostic criteria, with HbA1c≤7%. Participants selected are overweight or obese (24Kg/m2 ≤ BMI ≤40Kg/m2), and are planned to start the 1st/ 2nd cycle of IVF/ ICSI.\n\nInvestigators divide these patients randomly into 2 groups (each group with 127 patients): metformin only group (control group) and TRE with metformin group. Every participant receives the specific treatment according to the group for at least 6 weeks. During the intervention period, follow-ups, blood chemistry tests and examinations are recorded every 2 weeks. After the intervention period, IVF/ ICSI is carried out. GnRH-agonist- or/and hCG-triggered is used for ovarian stimulation. Ovum retrieval will be carried out 34-36h after ovarian stimulation. Blood hCG is tested after 12-14 days after embryonic transfer. For patients with positive hCG, clinical pregnancy is confirmed by observing gestational sac via transvaginal ultrasound after 4-5 weeks.\n\nInvestigators compare the terminal pregnancy-related result and metabolic changes between 2 groups to determine the effect and the possible mechanisms of TRE on IVF/ ICSI clinical pregnancy rate of PCOS with glucose metabolism disorder patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '38 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed with PCOS based on Rotterdam 2003 (all 3 criteria should be fulfilled);\n2. Diagnosed with glucose metabolism disorder (IGT, IFG, IGT with IFG, T2DM) and HbA1c less than or equal to 7%;\n3. Age 20-38;\n4. Overweight or obese (24Kg/m2 ≤ BMI ≤40Kg/m2);\n5. Indication for IVF/ ICSI (repeated ovarian stimulation failure/ Fallopian tube blockage/ male factor) and ready for the 1st/ 2nd cycle of IVF;\n6. Cooperative to follow-ups and capable of reporting severe adverse event (SAE);\n7. Completed informed consent.\n\nExclusion Criteria:\n\n1. Unilateral ovary resection;\n2. Abnormal uterus cavity (congenital, chronic endometrium inflammation, polyps, adhesion, fibroids, etc);\n3. Chromosomal abnormality (either maternal or paternal);\n4. Recurrent abortion or recurrent failure of embryo transfer;\n5. Metformin allergy/ intolerance;\n6. Other serious or uncontrolled diseases (e.g. kidney insufficiency, infection, controlled hypertension, heart disease, etc);\n7. Preimplantation genetic testing;\n8. Other condition that may impact the results'}, 'identificationModule': {'nctId': 'NCT06666933', 'briefTitle': 'Study of Time-restricted Eating (TRE) to Clinical Pregnancy Rate in PCOS Women With Glucose Metabolism Disorder Via IVF/ICSI', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Study of Time-restricted Eating (TRE) to Clinical Pregnancy Rate Via IVF/ICSI in Women With PCOS and Glucose Metabolism Disorder: A Multicenter Randomized Controlled Trial (RCT)', 'orgStudyIdInfo': {'id': 'LY2024-160'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Time restricted eating with metformin', 'description': 'TRE (eating is allowed from 8am to 4pm without limitation in calories) with metformin 1g bid po for 6 weeks', 'interventionNames': ['Behavioral: Time restricted eating', 'Drug: Metformin']}, {'type': 'OTHER', 'label': 'Metformin only', 'description': 'Taking metformin 1g bid po for 6 weeks only', 'interventionNames': ['Drug: Metformin']}], 'interventions': [{'name': 'Time restricted eating', 'type': 'BEHAVIORAL', 'description': 'TRE (eating is allowed from 8am to 4pm without limitation in calories) with metformin 1g bid po for 6 weeks', 'armGroupLabels': ['Time restricted eating with metformin']}, {'name': 'Metformin', 'type': 'DRUG', 'description': 'Taking metformin 1g bid po only for 6 weeks as control', 'armGroupLabels': ['Metformin only', 'Time restricted eating with metformin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'RenJi Hospital Department of Endocrinology and Metabolism', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Tao Tao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RenJi Hospital Department of Endocrinology and Metabolism'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'Shanghai First Maternity and Infant Hospital', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, {'name': 'Shengjing Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}