Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2026-01-01 @ 1:06 PM
Study NCT ID:
NCT06935968
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-20
First Post:
2025-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Levonorgestrel Intrauterine System on Hemoglobin Level
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-12', 'studyFirstSubmitDate': '2025-04-07', 'studyFirstSubmitQcDate': '2025-04-12', 'lastUpdatePostDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of blood haemoglobin level from time of insertion to 6 months after insertion', 'timeFrame': '6 months', 'description': 'To know the effect of LNG-IUDs on hemoglobin level after insertion'}], 'secondaryOutcomes': [{'measure': 'Change of serum ferritin level from time of insertion to 6 months after insertionPrevalence of iron deficiency and iron deficiency anemia in women requiring contraception in our community', 'timeFrame': '6 months', 'description': 'To know the effect of LNG-IUDs in serum ferritin'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemoglobin; Deficiency']}, 'descriptionModule': {'briefSummary': 'To study the effect of LNG-IUS on improving iron status in reproductive-aged women presenting for contraception.', 'detailedDescription': 'Women come to family planning clinic to insert levonorgestrel intrautrine system and take a blood sample from her to analyse hemoglobin level'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The study will include married women attending the outpatient clinics of the forementioned health facilities for contraception counseling\n2. Age between 18 and 45 years\n3. Women who choose LNG\\_IUS for contraception\n4. Any parity including nulliparous\n\nExclusion Criteria:\n\n* 1.Women with any inherited hemoglobinopathy (thalassemia, sickle cell anemia) or acquired hemolytic anemia 2.Women with sever iron deficiency anemia requiring immediate treatment 3.Women with any contraindication to Mirena insertion (pelvic inflammatory disease, cervical or vaginal infection, cervical cancer) 4. Any uterine abnormality making LNG\\_IUS insertion difficult (septate uterus or fibroid distorting the cavity) 5. Women within 6 months of delivery'}, 'identificationModule': {'nctId': 'NCT06935968', 'briefTitle': 'Effect of Levonorgestrel Intrauterine System on Hemoglobin Level', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Effect of Levonorgestrel Intrautrine System on Hemoglobin Level and Iron Profile on Women Requiring Contraception', 'orgStudyIdInfo': {'id': 'Mirena'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Levonorgestrel intrauterine system insertion', 'interventionNames': ['Device: Levonorgestrel intrautrine system']}], 'interventions': [{'name': 'Levonorgestrel intrautrine system', 'type': 'DEVICE', 'otherNames': ['Take a blood sample'], 'description': 'Insertion of levonorgestrel intrautrine system and take a blood sample from the women to analyse it', 'armGroupLabels': ['Levonorgestrel intrauterine system insertion']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mariam Melad', 'role': 'CONTACT', 'email': 'mariomamelad8@gmail.com', 'phone': '01020214925'}, {'name': 'Essam eldeen Rashad', 'role': 'CONTACT'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident doctor', 'investigatorFullName': 'Mariam Melad Matta', 'investigatorAffiliation': 'Assiut University'}}}}