Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT02433418
Status:
UNKNOWN
Last Update Posted:
2017-01-23
First Post:
2015-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tubal Flushing Using Water Soluble Media for Unexplained Infertility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004008', 'term': 'Diclofenac'}], 'ancestors': [{'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-20', 'studyFirstSubmitDate': '2015-04-24', 'studyFirstSubmitQcDate': '2015-05-04', 'lastUpdatePostDateStruct': {'date': '2017-01-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pregnancy', 'timeFrame': 'Monthly, up to 12 months', 'description': 'Pregnancy will be defined as the presence of an intrauterine sac by vaginal ultrasound'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Infertility']}, 'referencesModule': {'references': [{'pmid': '12517654', 'type': 'BACKGROUND', 'citation': 'Steiner AZ, Meyer WR, Clark RL, Hartmann KE. Oil-soluble contrast during hysterosalpingography in women with proven tubal patency. Obstet Gynecol. 2003 Jan;101(1):109-13. doi: 10.1016/s0029-7844(02)02390-6.'}, {'pmid': '10644101', 'type': 'BACKGROUND', 'citation': 'Spring DB, Barkan HE, Pruyn SC. Potential therapeutic effects of contrast materials in hysterosalpingography: a prospective randomized clinical trial. Kaiser Permanente Infertility Work Group. Radiology. 2000 Jan;214(1):53-7. doi: 10.1148/radiology.214.1.r00ja2353.'}, {'pmid': '17636730', 'type': 'BACKGROUND', 'citation': 'Luttjeboer F, Harada T, Hughes E, Johnson N, Lilford R, Mol BW. Tubal flushing for subfertility. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD003718. doi: 10.1002/14651858.CD003718.pub3.'}, {'pmid': '33053612', 'type': 'DERIVED', 'citation': 'Wang R, Watson A, Johnson N, Cheung K, Fitzgerald C, Mol BWJ, Mohiyiddeen L. Tubal flushing for subfertility. Cochrane Database Syst Rev. 2020 Oct 15;10(10):CD003718. doi: 10.1002/14651858.CD003718.pub5.'}]}, 'descriptionModule': {'briefSummary': '300 women with unexplained infertility will be randomly divided into 2 equal groups: Group 1 will be offered tubal flushing with water soluble media through hysterosalpingography (HSG) and group 2 will receive no intervention', 'detailedDescription': 'The potential therapeutic effect of diagnostic tubal patency testing has been debated for over 40 years. Tubal flushing might involve water- or oil-soluble media. Current practice usually involves water-soluble media when tubal flushing is performed at laparoscopy. A systematic review showed a significant increase in pregnancy rates with tubal flushing using oil-soluble contrast media when compared with no treatment. Tubal flushing with oil soluble contrast media was associated with an increase in the odds of live birth when compared with tubal flushing with water-soluble media. There were no trials assessing tubal flushing with water-soluble media versus no treatment. The potential consequences of extravasations of oil-soluble contrast media into the pelvic cavity and fallopian tubes may be associated with anaphylaxis and lipogranuloma. It has been reported that Further randomised controlled trials are needed to evaluate the potentially therapeutic effects of tubal flushing with water-soluble media.\n\nAll patients attending the subfertility clinic with infertility, normal semen analysis and evidence of ovulation will be invited to participate in the study. The nature of the study and its expected values will be explained and only women who provide written consents will be included in the study.\n\nThree hundred women will be divided into 2 equal groups using computer generated random numbers: Group 1 will have tubal flushing with HSG using water soluble media and group 2 will be the control group receiving no intervention.\n\nWomen undergoing HSG will be given 50 mg of diclofenac (Voltaren® Novartis) 1 hour before the procedure. The HSG will be performed in the same room, on the same table and with the same technique to maintain consistency and limit confounding variables.\n\nThe HSG procedure will performed in a lithotomy position. A sterile metal speculum was used to visualize the uterine cervix. Antiseptic solution will be used to wash the vagina and cervix. A single-toothed tenaculum will be placed on the anterior lip of the cervix. A metal cannula will be gently inserted into the external cervical os, the cannula and tenaculum will be secured together, and the speculum will be removed. Gentle traction will be placed on the tenaculum, and 15 mL to 20 mL of water-soluble media (Sodium Amidotrizoate; urografin®, Bayer, Germany) will be instilled slowly via the cannula to prevent pain while the necessary images were obtained. After the procedure, the instruments will be removed and the patient will be observed for 30 minutes.\n\nWomen will be followed up monthly for up to 1 year.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* infertility for one year\n* Normal semen analysis\n* Normal ovulation\n\nExclusion Criteria:\n\n* Allergy to Iodine\n* Metformin therapy\n* Tubal block'}, 'identificationModule': {'nctId': 'NCT02433418', 'briefTitle': 'Tubal Flushing Using Water Soluble Media for Unexplained Infertility', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Tubal Flushing Using Water Soluble Media for Unexplained Infertility: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'sub 9'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tubal flushing with Urografin®', 'description': 'Women will have HSG using water soluble media', 'interventionNames': ['Procedure: Tubal flushing by Urografin®', 'Drug: Diclofenac']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Women will not receive any intervention'}], 'interventions': [{'name': 'Tubal flushing by Urografin®', 'type': 'PROCEDURE', 'description': 'Women will have tubal flushing through HSG using water soluble media (Urographin ®)', 'armGroupLabels': ['Tubal flushing with Urografin®']}, {'name': 'Diclofenac', 'type': 'DRUG', 'description': 'Women will receive oral diclofenac 50 mg (voltaren ®) 1 hour before hysterosalpingography', 'armGroupLabels': ['Tubal flushing with Urografin®']}]}, 'contactsLocationsModule': {'locations': [{'city': 'BeniSuef', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Nesreen AA Shehata, MD', 'role': 'CONTACT', 'email': 'nesoomar@yahoo.com', 'phone': '+2001227866337'}], 'facility': 'BeniSuef University hospitals'}, {'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'AbdelGany MA Hassan, MRCOG, MD', 'role': 'CONTACT', 'email': 'abdelgany2@gmail.com', 'phone': '00217801604'}, {'name': 'AbdelGany MA Hassan, MRCOG, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cairo University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Gynecology and Obstetrics', 'investigatorFullName': 'AbdelGany Hassan', 'investigatorAffiliation': 'Cairo University'}}}}