Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-02-01 @ 5:51 PM
Study NCT ID:
NCT01425333
Status:
UNKNOWN
Last Update Posted:
2011-08-30
First Post:
2011-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Surgical Treatment of Endometriomas on Ovarian Reserve
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2013-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-08-26', 'studyFirstSubmitDate': '2011-08-25', 'studyFirstSubmitQcDate': '2011-08-26', 'lastUpdatePostDateStruct': {'date': '2011-08-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anti-Mullerian Hormone (AMH)', 'timeFrame': '6 months post-operatively', 'description': 'Change in anti-mullerian hormone level after surgery (at one week, three months and six months)'}], 'secondaryOutcomes': [{'measure': 'Follicle Stimulating Hormone (FSH)', 'timeFrame': '6 months', 'description': 'Change in follicle stimulating hormone levels after surgery (at one week, three months and six months)'}, {'measure': 'Antral Follicle Count (AFC)', 'timeFrame': '3 months', 'description': 'Change in AFC after surgery (at three months)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ovarian endometriomas', 'Laparoscopy', 'Cystectomy', 'Ablation'], 'conditions': ['Endometriosis']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess which of two commonly used surgical procedures in the treatment of ovarian cysts called endometriomas (cutting out of the cyst - "cystectomy", or draining it and cauterising it\'s inner lining - "ablation") causes the least damage to the ovary and is therefore best at maintaining the future fertility potential of a patient.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women undergoing laparoscopic surgery for treatment of unilateral endometriomas measuring ≥ 3cm and ≤ 8cm in diameter\n\nExclusion Criteria:\n\n* Patients who have received oestrogen suppressing drugs (e.g. oral contraceptive pills, GnRHa) during the previous six months\n* Patients who have previously undergone surgical treatment of endometriomas\n* Patients with bilateral endometriomas\n* Patients with endometriomas of less than 3cm in size or more than 8cm in size\n* Pre-surgical evidence of reduced ovarian reserve\n* Pregnant patients\n* Patients unable to give informed consent e.g. patients with mental incapacity'}, 'identificationModule': {'nctId': 'NCT01425333', 'briefTitle': 'The Impact of Surgical Treatment of Endometriomas on Ovarian Reserve', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals of Derby and Burton NHS Foundation Trust'}, 'officialTitle': 'The Impact of Surgical Treatment of Ovarian Endometriomas on Ovarian Reserve: a Randomised Controlled Trial of Laparoscopic Ovarian Cystectomy Versus Cyst Ablation - a Pilot Study', 'orgStudyIdInfo': {'id': 'R&D: DHRD/2010/089'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cystectomy', 'description': 'Patients undergoing cystectomy for ovarian endometrioma', 'interventionNames': ['Procedure: Surgery for ovarian endometrioma']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ablation', 'description': 'Patients undergoing ablation for ovarian endometrioma', 'interventionNames': ['Procedure: Surgery for ovarian endometrioma']}], 'interventions': [{'name': 'Surgery for ovarian endometrioma', 'type': 'PROCEDURE', 'otherNames': ['Patients undergoing cystectomy for ovarian endometrioma'], 'description': 'Patients undergoing surgery for ovarian endometrioma', 'armGroupLabels': ['Cystectomy']}, {'name': 'Surgery for ovarian endometrioma', 'type': 'PROCEDURE', 'otherNames': ['Patients undergoing cystectomy for ovarian endometrioma'], 'description': 'Patients undergoing surgery for ovarian endometrioma', 'armGroupLabels': ['Ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DE22 3NE', 'city': 'Derby', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Saad Amer, MD, MRCOG', 'role': 'CONTACT', 'email': 'saad.amer@nottingham.ac.uk', 'phone': '+44(1332)724612'}, {'name': 'Francesca Raffi, MBChB, MRCOG', 'role': 'CONTACT'}], 'facility': 'Royal Derby Hospital', 'geoPoint': {'lat': 52.92277, 'lon': -1.47663}}], 'centralContacts': [{'name': 'Saad Amer, MD, MRCOG', 'role': 'CONTACT', 'email': 'saad@amer@nottigham.ac.uk', 'phone': '+44(1332)724612'}], 'overallOfficials': [{'name': 'Saad Amer, MD, MRCOG', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nottingham and Derby Hospitals NHS foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saad Amer', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospitals of Derby and Burton NHS Foundation Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor in Gynaecology', 'investigatorFullName': 'Saad Amer', 'investigatorAffiliation': 'University Hospitals of Derby and Burton NHS Foundation Trust'}}}}