Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-31 @ 11:43 PM
Study NCT ID:
NCT05846906
Status:
COMPLETED
Last Update Posted:
2023-05-30
First Post:
2023-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Oral Sildenafil Citrate on Improvement of Endometrial Thickness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}], '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'}, {'id': 'D007246', 'term': 'Infertility'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068677', 'term': 'Sildenafil Citrate'}, {'id': 'D002996', 'term': 'Clomiphene'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-25', 'studyFirstSubmitDate': '2023-04-15', 'studyFirstSubmitQcDate': '2023-04-26', 'lastUpdatePostDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pregnancy rate', 'timeFrame': 'at the end of the cycle (28 days)', 'description': 'Serum pregnancy test (positive/negative)'}], 'secondaryOutcomes': [{'measure': 'endometrial thickness', 'timeFrame': '1 month', 'description': 'measured by trans-vaginal ultrasound'}, {'measure': 'ovulation rate', 'timeFrame': '1 month', 'description': 'using trans-vaginal ultrasound'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility, Female']}, 'descriptionModule': {'briefSummary': 'One hundred thirty women with unexplained infertility participated in a prospective clinical study. Patients were assigned at random to one of two groups. The first group (n=65) served as the study group and was given clomiphene citrate 50 mg (Tecnovula®, Techno Pharmaceuticals, Egypt) and sildenafil (Respatio®, Pharma right group, Egypt) 20 mg tablets. The second group (n=65) served as a control and received a placebo tablet in addition to the standard treatment of clomiphene citrate 50 mg (Tecnovula®). A transvaginal ultrasound was performed on all of the patients to assess ovulation.', 'detailedDescription': 'One hundred thirty women with unexplained infertility participated in a prospective clinical study. Patients were assigned at random to one of two groups. The first group (n=65) served as the study group and was given clomiphene citrate 50 mg (Tecnovula®, Techno Pharmaceuticals, Egypt) orally twice daily from the second day of their cycle through the seventh day and sildenafil (Respatio®, Pharma right group, Egypt) 20 mg tablets from the end of menstruation through ovulation. The second group (n=65) served as a control and received a placebo tablet in addition to the standard treatment of clomiphene citrate 50 mg (Tecnovula®). A transvaginal ultrasound was performed on all of the patients to assess ovulation, follicle count, and pregnancy. Consequences, including miscarriage, ectopic pregnancy, and multiple pregnancies, were monitored.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ages of 18 to 40\n* patent tubes\n* unexplained infertility\n* regular menstrual cycle\n* husband with normal sperm parameters\n\nExclusion Criteria:\n\n* hypotension\n* cardiovascular, renal and hepatic diseases\n* uncontrolled diabetes mellitus\n* anovulatory infertility\n* abnormal thyroid functions\n* ovarian cysts\n* patients taking nitrates\n* pelvic adhesions\n* abnormal hormonal profile.\n* hyperprolactinemia\n* multiple uterine fibroids\n* adenomyosis and endometriosis suspicion'}, 'identificationModule': {'nctId': 'NCT05846906', 'briefTitle': 'Effect of Oral Sildenafil Citrate on Improvement of Endometrial Thickness', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'Oral Sildenafil Citrate: a Potential Approach for Improvement of Endometrial Thickness and Treatment of Unexplained Infertility in Women', 'orgStudyIdInfo': {'id': 'REC-H-PhBSU-21015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sildenafil and clomiphene citrate', 'description': 'Oral Clomiphene citrate (Tecnovula®) 50 mg was taken twice daily by the experimental group from day 2 through day 7 of the cycle, and oral sildenafil (Respatio® 20mg for 5 days) was taken from the last day of menstruation until reaching ovulation.', 'interventionNames': ['Drug: Sildenafil Citrate', 'Drug: Clomiphene Citrate 50mg']}, {'type': 'OTHER', 'label': 'clomiphene citrate alone', 'description': 'Oral Clomiphene citrate (Tecnovula®) 50 mg was taken twice daily by the control group from day 2 through day 7 of the cycle in addition to a placebo tablet.', 'interventionNames': ['Drug: Clomiphene Citrate 50mg']}], 'interventions': [{'name': 'Sildenafil Citrate', 'type': 'DRUG', 'otherNames': ['respatio'], 'description': 'oral sildenafil (Respatio® 20mg )', 'armGroupLabels': ['Sildenafil and clomiphene citrate']}, {'name': 'Clomiphene Citrate 50mg', 'type': 'DRUG', 'otherNames': ['technovula'], 'description': 'used for ovionulation induct', 'armGroupLabels': ['Sildenafil and clomiphene citrate', 'clomiphene citrate alone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Banī Suwayf', 'country': 'Egypt', 'facility': 'Beni-suef university', 'geoPoint': {'lat': 29.07441, 'lon': 31.09785}}], 'overallOfficials': [{'name': 'Beni-Suef University', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Medicine Beni-Suef University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beni-Suef University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University', 'investigatorFullName': 'Sara Abdallah Mohamed Salem', 'investigatorAffiliation': 'Beni-Suef University'}}}}