Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 11:25 PM
Study NCT ID:
NCT06775093
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-14
First Post:
2025-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of GLP-1RAs on Reproductive Outcomes in PCOS and Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007247', 'term': 'Infertility, Female'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'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': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007246', 'term': 'Infertility'}]}, '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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 392}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-09', 'studyFirstSubmitDate': '2025-01-04', 'studyFirstSubmitQcDate': '2025-01-09', 'lastUpdatePostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Live birth rate', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': 'BMI change from baseline to the 3rd month in kg/m2', 'timeFrame': '3 months'}, {'measure': 'Spontaneous resumption of ovulation', 'timeFrame': '3 months'}, {'measure': 'Clinical pregnancy', 'timeFrame': '9 months'}, {'measure': 'Ongoing pregnancy', 'timeFrame': '11 months'}, {'measure': 'Pregnancy loss', 'timeFrame': '18 months'}, {'measure': 'Gestational age at delivery', 'timeFrame': '18 months'}, {'measure': 'Time to pregnancy leading to live birth', 'timeFrame': '18 months'}, {'measure': 'Hypertensive disorders of pregnancy', 'timeFrame': '18 months'}, {'measure': 'Gestational diabetes', 'timeFrame': '18 months'}, {'measure': 'Birth weight in kg', 'timeFrame': '18 months'}, {'measure': 'Neonatal mortality', 'timeFrame': '18 months'}, {'measure': 'Major congenital anomaly', 'timeFrame': '18 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polycystic Ovary Syndrome', 'Obesity', 'Infertility, Female']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to examine whether benalutide combined with metformin and healthy lifestyle education in women with PCOS and obesity prior to fertility treatment improves live birth rate and other reproductive, maternal and perinatal outcomes compared to metformin plus healthy lifestyle education.', 'detailedDescription': 'Benalutide, a short-acting recombinant human GLP-1RAs with nearly 100% homology to human GLP-1, has been approved by the Chinese National Medical Products Administration for treating weight loss in individuals with obesity. Up to now, there is a paucity of research on the potential impact of GLP-1RAs on reproductive, maternal and perinatal outcomes in women with PCOS and obesity undergoing fertility treatment. Given its effectiveness as a weight loss medication, benalutide theoretically holds promise for enhancing reproductive outcomes in women with PCOS and obesity prior to fertility treatment by facilitating weight reduction.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nWomen with a wish to conceive; Women with PCOS (Rotterdam criteria); 28 kg/m2≤BMI\\<35kg/m2;\n\nExclusion Criteria:\n\nWomen with medical morbidity; Endocrine disorders; Abnormalities in liver and kidney function; Other medications such as glucocorticoids, anti-androgen drugs ;(spironolactone, cyproterone acetate, flutamide, etc.) within the last 3 months; Acute infections, severe cardiovascular disease, malignant tumors; Ongoing weight loss therapy (\\>5% weight loss in the last 3 months) or history of gastrointestinal surgery; Uterine anomalies or untreated tubal hydrosalpinx; Receiving a donor oocyte or donor sperm cycle; Chromosome abnormality or recurrent miscarriage; planning preimplantation genetic testing (PGT); Any other contraindications to fertility treatment; Allergic to or contraindicated for GLP-1 class medications.'}, 'identificationModule': {'nctId': 'NCT06775093', 'briefTitle': 'Effects of GLP-1RAs on Reproductive Outcomes in PCOS and Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Effects of GLP-1 Receptor Agonists Combined with Metformin and Healthy Lifestyle Education Prior to Fertility Treatment on Reproductive Outcomes in Women with PCOS and Obesity', 'orgStudyIdInfo': {'id': 'M2024472'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GLP-1 RAs combined with metformin and healthy lifestyle education', 'description': 'Benaglutide injection (Fisuomei®, National Medicine Standard No. S20230042, Shanghai Renhui Biopharmaceutical Co., Ltd.) was administered at an initial dose of 0.06 mg per injection, three times daily, via subcutaneous injection 5 minutes before meals. After establishing tolerance, the dose was increased weekly by 0.04 mg per injection, reaching 0.2 mg per injection after four weeks, administered three times daily for a total of 12 weeks. Metformin hydrochloride (Glucophage®, National Medicine Standard No. H20023370, Shanghai Bristol-Myers Squibb Pharmaceuticals Co., Ltd.) was prescribed at a dose of 0.5 g twice daily for 12 weeks, taken with meals. After 12 weeks of treatment or achieving a 10% reduction in baseline body weight, the medications were discontinued. Patients were advised to maintain a healthy diet and engage in appropriate physical activity. Assisted pregnancy treatments were initiated 4 weeks after completing the weight loss phase.', 'interventionNames': ['Drug: GLP-1 receptor agonist', 'Drug: Metformin', 'Behavioral: healthy lifestyle education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'metformin and healthy lifestyle education', 'description': 'Metformin hydrochloride (Glucophage®, National Medicine Standard No. H20023370, Shanghai Bristol-Myers Squibb Pharmaceuticals Co., Ltd.) was administered at a dose of 0.5 g twice daily for 12 weeks, taken with meals. After 12 weeks of treatment or achieving a 10% reduction in baseline body weight, the medication was discontinued. Patients were instructed to maintain a healthy diet and engage in appropriate physical activity. Assisted pregnancy treatment was initiated 4 weeks after completing the weight loss phase.', 'interventionNames': ['Drug: Metformin', 'Behavioral: healthy lifestyle education']}], 'interventions': [{'name': 'GLP-1 receptor agonist', 'type': 'DRUG', 'otherNames': ['Benaglutide'], 'description': '3 months', 'armGroupLabels': ['GLP-1 RAs combined with metformin and healthy lifestyle education']}, {'name': 'Metformin', 'type': 'DRUG', 'description': '3 months', 'armGroupLabels': ['GLP-1 RAs combined with metformin and healthy lifestyle education', 'metformin and healthy lifestyle education']}, {'name': 'healthy lifestyle education', 'type': 'BEHAVIORAL', 'description': '3 months', 'armGroupLabels': ['GLP-1 RAs combined with metformin and healthy lifestyle education', 'metformin and healthy lifestyle education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'role': 'CONTACT', 'email': 'wangzhengmedicine@163.com'}], 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Shuo Huang', 'role': 'CONTACT', 'email': 'homelyleaf@aliyun.com', 'phone': '+861082266699'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dean', 'investigatorFullName': 'Jie Qiao', 'investigatorAffiliation': 'Peking University Third Hospital'}}}}