Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-03-28 @ 8:23 PM
Study NCT ID:
NCT03784404
Status:
UNKNOWN
Last Update Posted:
2018-12-21
First Post:
2018-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trans-vaginal Aspiration of Small Ovarian Endometrioma. Comparison of Two Different Techniques Before ICSI
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': 'C013695', 'term': 'Surgicel'}, {'id': 'D020554', 'term': 'Sperm Injections, Intracytoplasmic'}], 'ancestors': [{'id': 'D005307', 'term': 'Fertilization in Vitro'}, {'id': 'D027724', 'term': 'Reproductive Techniques, Assisted'}, {'id': 'D012099', 'term': 'Reproductive Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-20', 'studyFirstSubmitDate': '2018-12-20', 'studyFirstSubmitQcDate': '2018-12-20', 'lastUpdatePostDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical pregnancy rate', 'timeFrame': '14 days after embryo transfer', 'description': 'documentation of intrauterine fetal sac using transvaginal ultrasound'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ovarian Endometrioma']}, 'descriptionModule': {'briefSummary': 'women candidate for ICSI and having ovarian endometrioma smaller than 5 cm will be randomized to either transvaginal aspiration alone or transvaginal aspiration follwed by injection of small parts of oxidized regenerated cellulose within the cyst cavity during the cycle that preceded the induction cycle of ICSI', 'detailedDescription': 'women candidate for ICSI and having ovarian endometrioma smaller than 5 cm will be randomized to either transvaginal aspiration alone or transvaginal aspiration follwed by injection of small parts of oxidized regenerated cellulose within the cyst cavity during the cycle that preceded the induction cycle of ICSI.\n\nTransvaginal aspiration will be done under ultrasonographic guidance with spinal needle insertion inside the cyst cavity followed by aspiration of the chocolate material from the cyst \\& then irrigation of the cyst cavity with normal saline solution till complete elimination of the chocolate material. The needle will be withdrawn in women in non-Surgicel group while injection of small pieces of surgicel inside the cyst cavity will be done for women in the surgicel group followed by withdrawal of the needle.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subfertile women indicated for ICSI\n* having a single endometrioma of less than 5 cm with typical sonographic criteria; a cyst with 1 to 4 locules and ground glass appearance of the cyst fluid with no papillary projections and no or minimal vascularization of the cyst capsule. Since endometriotic cysts measuringmore than 1 cm are readily diagnosed by ultrasound,25 we chose a diameter of 2 cm as the lower limit to declare a cyst as endometrioma.\n* All cases had a normal uterine cavity demonstrated by ultrasonography and hysteroscopy.\n\nExclusion Criteria:\n\n* bilateral or multiple endometriomas, lesions of more than 5 cm or showing atypical sonographic features presence of uterine pathology (eg, polyp or fibroid)\n* follicle-stimulating hormone (FSH) of more than 10,\n* body mass index of more than 30, age more than 40 years,\n* cases who received previous GnRH therapy for treatment of endometriosis within 12 months of the study\n* patients who received oral contraceptive pills or any form of hormones for the previous 3 months,\n* patients with previous surgical resection of endometrioma\n* severe male factor.'}, 'identificationModule': {'nctId': 'NCT03784404', 'briefTitle': 'Trans-vaginal Aspiration of Small Ovarian Endometrioma. Comparison of Two Different Techniques Before ICSI', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Trans-vaginal Aspiration With or Without Injection of Surgicel for Treatment of Small Ovarian Endometrioma Before ICSI Cycles. A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '45'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Non surgicel group', 'description': 'under sedation transvaginal insertion of spinal needle through the cul de sac under ultrasonographic guidance to reach cyst cavity followed by aspiration of the chocolate material followed by irrigation of the cyst cavity with normal saline solution till complete elimination of the chocolate material', 'interventionNames': ['Procedure: Transvaginal aspiration', 'Drug: Intracytoplasmic sperm injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Surgicel group', 'description': 'under sedation transvaginal insertion of spinal needle through the cul de sac under ultrasonographic guidance to reach cyst cavity followed by aspiration of the chocolate material followed by irrigation of the cyst cavity with normal saline solution till complete elimination of the chocolate material follwed by insertion of 3-4 pieces of small surgicel inside the cyst cavity', 'interventionNames': ['Procedure: transvaginal aspiration and surgicel injection', 'Drug: Intracytoplasmic sperm injection']}], 'interventions': [{'name': 'Transvaginal aspiration', 'type': 'PROCEDURE', 'description': 'under sedation transvaginal insertion of spinal needle through the cul de sac under ultrasonographic guidance to reach cyst cavity followed by aspiration of the chocolate material followed by irrigation of the cyst cavity with normal saline solution till complete elimination of the chocolate material', 'armGroupLabels': ['Non surgicel group']}, {'name': 'transvaginal aspiration and surgicel injection', 'type': 'PROCEDURE', 'description': 'under sedation transvaginal insertion of spinal needle through the cul de sac under ultrasonographic guidance to reach cyst cavity followed by aspiration of the chocolate material followed by irrigation of the cyst cavity with normal saline solution till complete elimination of the chocolate material follwed by insertion of 3-4 pieces of small surgicel inside the cyst cavity', 'armGroupLabels': ['Surgicel group']}, {'name': 'Intracytoplasmic sperm injection', 'type': 'DRUG', 'description': 'Candidates for the standard long protocol received triptorelin 0.1 mg Subcutanous daily starting from day 21 of the previous cycle. On the second day of the stimulation cycle, pituitary downregulation was confirmed. Controlled ovarian stimulation was then started on day 3 using Human Menopausal Gonadotropin (Menogon; Ferring). The dose of gonadotropin was individualized. The patients were monitored with serial ultrasound and serum E2. When at least 3 follicles reached 18 mm, ovulation was triggered using Human Chorionic Gonadotropin 10000 IU (Epifasi 10000 IU; Eipico, Tenth of Ramadan, Egypt) IM and ovum pickup was performed 35 hours later.\n\nAll cases received luteal support in the form of progesterone 400 mg twice daily. Embryo transfer was done on day 3 or 5 using Labotect semi-rigid catheter (Labotect GmbH, Kassel area, Germany) under abdominal ultrasound guidance.', 'armGroupLabels': ['Non surgicel group', 'Surgicel group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12151', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasr Alainy medical school', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Ahmed Maged, MD', 'role': 'CONTACT', 'email': 'prof.ahmedmaged@gmail.com', 'phone': '+201005227404'}, {'name': 'fadel shaltout, MD', 'role': 'CONTACT', 'email': 'dr.shaltout@gmail.com', 'phone': '+201006023073'}], 'overallOfficials': [{'name': 'Ahmed Maged, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Ahmed Maged', 'investigatorAffiliation': 'Cairo University'}}}}