Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-30 @ 9:06 AM
Study NCT ID:
NCT01046032
Status:
COMPLETED
Last Update Posted:
2010-01-11
First Post:
2010-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metformin Treatment Before in Vitro Fertilization (IVF) in Women With Ultrasound Evidence of Polycystic Ovaries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}], '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'}]}, '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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 134}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-08', 'studyFirstSubmitDate': '2010-01-03', 'studyFirstSubmitQcDate': '2010-01-08', 'lastUpdatePostDateStruct': {'date': '2010-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Live birth rate', 'timeFrame': 'End of pregnancy'}], 'secondaryOutcomes': [{'measure': 'Severe ovarian hyperstimulation syndrome', 'timeFrame': '2 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Polycystic ovaries', 'Ovarian stimulation', 'IVF', 'Ovarian hyperstimulation', 'Metformin'], 'conditions': ['Polycystic Ovary Syndrome']}, 'referencesModule': {'references': [{'pmid': '16501038', 'type': 'BACKGROUND', 'citation': 'Tang T, Glanville J, Orsi N, Barth JH, Balen AH. The use of metformin for women with PCOS undergoing IVF treatment. Hum Reprod. 2006 Jun;21(6):1416-25. doi: 10.1093/humrep/del025. Epub 2006 Feb 24.'}, {'pmid': '15117902', 'type': 'BACKGROUND', 'citation': 'Kjotrod SB, von During V, Carlsen SM. Metformin treatment before IVF/ICSI in women with polycystic ovary syndrome; a prospective, randomized, double blind study. Hum Reprod. 2004 Jun;19(6):1315-22. doi: 10.1093/humrep/deh248. Epub 2004 Apr 29.'}, {'pmid': '21593045', 'type': 'DERIVED', 'citation': 'Swanton A, Lighten A, Granne I, McVeigh E, Lavery S, Trew G, Talmor A, Raine-Fenning N, Jayaprakasan K, Child T. Do women with ovaries of polycystic morphology without any other features of PCOS benefit from short-term metformin co-treatment during IVF? A double-blind, placebo-controlled, randomized trial. Hum Reprod. 2011 Aug;26(8):2178-84. doi: 10.1093/humrep/der120. Epub 2011 May 18.'}]}, 'descriptionModule': {'briefSummary': 'The aim of study was to investigate whether pre-treatment with metformin before and during IVF increases the live birth rate compared to placebo in women with sonographic evidence of polycystic ovaries (PCO), but without any clinical manifestations of polycystic ovary syndrome (PCOS).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '38 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women attending with ovulatory PCO due to undergo IVF/ICSI treatment.\n* First or second cycle of IVF/ICSI.\n* If previously on metformin, a minimum one month washout period was required.\n* Polycystic ovaries diagnosed by ultrasound presence of ≥12 follicles measuring 2-9 mm in diameter in at least one ovary and/or increased ovarian volume (≥10 ml).\n* Written informed consent.\n\nExclusion Criteria:\n\n* Clinical manifestations of PCOS, including any of the following:\n\n 1. Oligo- or amenorrhoea with cycles ≥42 days apart.\n 2. Anovulation with mid-luteal progesterone \\<16 nmol/L.\n 3. Biochemical hyperandrogenism with serum testosterone ≥3.5 nmol/L and/or free androgen index \\>5 (FAI = \\[total testosterone/SHBG\\] x 100).\n 4. Clinical hyperandrogenism with hirsutism or acne requiring treatment at least weekly.\n* Age \\>38 years.\n* BMI \\>35 kg/m2.\n* Basal FSH \\>12 IU/L.\n* Liver disease or ALT \\>80 IU/L.\n* Renal disease, or creatinine \\>130 nmol/L.\n* Alcoholism or drug abuse.\n* Diabetes mellitus (evaluated by fasting glucose \\>6.7mmol/L).\n* Per oral steroid treatment in last month.\n* Cimetidine, anticoagulation, erythromycin, or other macrolides in last month.\n* Hyperprolactinemia (Prolactin \\>700 mIU/L).\n* Abnormal thyroid function tests (TSH outside of laboratory normal range).\n* Congenital adrenal hyperplasia.'}, 'identificationModule': {'nctId': 'NCT01046032', 'briefTitle': 'Metformin Treatment Before in Vitro Fertilization (IVF) in Women With Ultrasound Evidence of Polycystic Ovaries', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'Metformin Treatment Before IVF in Women With Ultrasound Evidence of Polycystic Ovaries; a Prospective, Randomised, Double Blind, Placebo Study', 'orgStudyIdInfo': {'id': '05/Q1605/87'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin', 'description': 'Drug (including placebo)', 'interventionNames': ['Drug: Metformin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sugar pill', 'description': 'Drug (including placebo)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'description': 'Women were randomised to receive either metformin or placebo starting three weeks before initiation of a GnRH agonist during an IVF treatment cycle (seven weeks prior to oocyte collection and then stopped at oocyte collection). Seventy identical packs of metformin and 70 identical packs of placebo were supplied by DHP Ltd, Crickhowell, Powys (UK) a commercial clinical trial supplier. The randomisation service was provided by DHP Ltd.', 'armGroupLabels': ['Metformin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Women were randomised to receive either metformin or placebo starting three weeks before initiation of a GnRH agonist during an IVF treatment cycle (seven weeks prior to oocyte collection and then stopped at oocyte collection). Seventy identical packs of metformin and 70 identical packs of placebo were supplied by DHP Ltd, Crickhowell, Powys (UK) a commercial clinical trial supplier. The randomisation service was provided by DHP Ltd.', 'armGroupLabels': ['Sugar pill']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': 'IVF Hammersmith', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Nuture IVF Unit', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': 'OX39DU', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Oxford Fertility Unit', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Tim J Child, MA MD MRCOG', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Oxford'}, {'name': 'Alexander G Swanton, MBBS MRCOG', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oxford'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'collaborators': [{'name': 'Imperial College London', 'class': 'OTHER'}, {'name': 'University of Nottingham', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Mr Tim Child/Consultant Gynaecologist and Chief Investigator', 'oldOrganization': 'University of Oxford'}}}}