Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-25 @ 4:58 PM
Study NCT ID:
NCT03533803
Status:
COMPLETED
Last Update Posted:
2018-12-14
First Post:
2018-05-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Indomethacin Prior to Difficult Embryo Transfer is it a Solution?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007213', 'term': 'Indomethacin'}, {'id': 'D013488', 'term': 'Suppositories'}], 'ancestors': [{'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-12-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-13', 'studyFirstSubmitDate': '2018-05-12', 'studyFirstSubmitQcDate': '2018-05-12', 'lastUpdatePostDateStruct': {'date': '2018-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implantation rate', 'timeFrame': '6 weeks', 'description': 'the number of total gestational sacs divided by the total number of embryos transferred.'}], 'secondaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': '6 weeks', 'description': 'Presence of fetal pulsations after 2 weeks from the positive pregnancy test.'}, {'measure': 'Ongoing pregnancy rate', 'timeFrame': '12 weeks', 'description': 'Pregnancies continuing beyond 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Difficult Embryo Transfer']}, 'descriptionModule': {'briefSummary': 'IVF/ICSI patients who had difficult mock embryo transfer on the day of ovum pick up. Will be randomly assigned into two groups; group A will receive 100mg indomethacin rectal suppository 1-2 hours before ET and group B will not receive indomethacin'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '38 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infertile patients undergoing IVF cycle with difficult mock embryo transfer\n* Early follicular FSH level ≤10 IU/L.\n* Tubal, male infertility and unexplained causes of fertility will be recruited.\n* Fresh ET.\n\nExclusion Criteria:\n\n* Repeated IVF failure.\n* Past history of allergy to NSAID, bronchial asthma , peptic ulcer or inflammatory bowel disease.\n\n * Easy mock embryo transfer.'}, 'identificationModule': {'nctId': 'NCT03533803', 'briefTitle': 'Indomethacin Prior to Difficult Embryo Transfer is it a Solution?', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Indomethacin Prior to Difficult Embryo Transfer is it a Solution?', 'orgStudyIdInfo': {'id': '12018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A (Indomethacin)', 'description': 'All patient had long stimulation protocol and IVF/ICSI. After mock embryo transfer women with any degree of difficulty will receive Indomethacin 100Mg Suppository 1-2 hours before embryo transfer.', 'interventionNames': ['Drug: Indomethacin 100Mg Suppository', 'Procedure: IVF/ICSI']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group B (Control)', 'description': 'All patient had long stimulation protocol and IVF/ICSI. After mock embryo transfer women with any degree of difficulty will not receive any medications before embryo transfer.', 'interventionNames': ['Procedure: IVF/ICSI']}], 'interventions': [{'name': 'Indomethacin 100Mg Suppository', 'type': 'DRUG', 'otherNames': ['Indomethacin'], 'description': 'Indomethacin 100Mg Suppository will be given 1 to 2 hours before embryo transfer in cases with difficult mock embryo transfer in the active comparator group.', 'armGroupLabels': ['Group A (Indomethacin)']}, {'name': 'IVF/ICSI', 'type': 'PROCEDURE', 'description': 'patients received induction with the long agonist stimulation protocol. Followed by ovum pickup and embryo transfer. Only those with difficult mock embryo transfer will be recruited in this study.', 'armGroupLabels': ['Group A (Indomethacin)', 'Group B (Control)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12411', 'city': 'Giza', 'country': 'Egypt', 'facility': 'Nile IVF center', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Sarwat Ahawany, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nile Ivf Center, Cairo, Egypt', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Obstetrics and Gynaecology', 'investigatorFullName': 'Yasmin Ahmed Bassiouny', 'investigatorAffiliation': 'Cairo University'}}}}