Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:56 PM
Study NCT ID:
NCT03890458
Status:
COMPLETED
Last Update Posted:
2019-03-26
First Post:
2019-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Vitamin D on Fertility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}, {'id': 'D007247', 'term': 'Infertility, Female'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-25', 'studyFirstSubmitDate': '2019-03-11', 'studyFirstSubmitQcDate': '2019-03-25', 'lastUpdatePostDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Vitamin D level', 'timeFrame': 'The 25 (OH)D levels of the experimental group women were tested on the second or third day of their menstrual cycle. (Pretest)', 'description': 'The vitamin D blood test was measured by the level of 25(OH)D.'}, {'measure': 'Blood Vitamin D level', 'timeFrame': 'The 25 (OH)D levels of the women were tested on the two weeks after embryo transfer. (Posttest)', 'description': 'The vitamin D blood test was measured by the level of 25(OH)D.'}], 'secondaryOutcomes': [{'measure': 'Biochemical pregnancy', 'timeFrame': 'HCG levels of the women were evaluated on the two weeks after embryo transfer (Post test)', 'description': 'The pregnancy test was measured level of HCG in the blood.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vitamin D', 'vitamin D supplementation', 'infertility', 'D vitamin deficiency', 'infertile women', 'embryo transfer', 'pregnancy rate'], 'conditions': ['Infertility', 'Infertility, Female', 'Vitamin D Deficiency', 'Vitamin D3 Deficiency']}, 'descriptionModule': {'briefSummary': 'Objective: To examine the effect of vitamin D supplements on the pregnancy and clinical pregnancy rate in embryo transfer cycles.\n\nDesign: Experimental study with a pre- and post-test. Setting: In Vitro Fertilization Center Patients: Its sample consisted of 118 women, 58 in the experimental group and 60 in the control group.\n\nIntervention(s): At the beginning of the infertility treatment, the experimental group took vitamin D supplements, and the control group did not. Vitamin D supplementation for infertile women includes regulation of a diet rich in vitamin D, educational and motivational interviews about insolation, and taking vitamin D orally.\n\nMain Outcome Measure(s): 25(OH)D and beta HCG levels'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-45 years old\n* literate in Turkish\n* voluntary participation\n* primarily infertile\n* had undergone controlled ovarian hyperstimulation and had a fresh ET\n* vitamin D levels lower than 30ng/mL before infertility treatment\n\nExclusion Criteria:\n\n* patients with uncorrected congenital or acquired uterine anomalies\n* bone, parathyroid gland, kidney and liver disorders\n* use of anticonvulsants/antacid drugs\n* taking dietary supplements contain vitamin D\n* secondary infertility'}, 'identificationModule': {'nctId': 'NCT03890458', 'briefTitle': 'The Effect of Vitamin D on Fertility', 'organization': {'class': 'OTHER', 'fullName': 'Akdeniz University'}, 'officialTitle': 'Effects of Vitamin D Supplements on Pregnancy Outcomes in Embriyo Transfer Cycles', 'orgStudyIdInfo': {'id': '02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'interventionNames': ['Drug: DEVIT-3']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'DEVIT-3', 'type': 'DRUG', 'description': 'The physicians gave the women in the experimental group vitamin D oral drops in an ampoule of 300,000 IU and a vial of 50,000 IU to take during the IVF treatment. Written and verbal information about how to take vitamin D was provided to the participants by the nurses. The women took 300,000 IU vitamin D orally for the first week. In the second week of the treatment, 50,000 IU vitamin D (15 drops/day) was used as maintenance dose until the pregnancy test day.', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antalya', 'country': 'Turkey (Türkiye)', 'facility': 'Murat Özekinci', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}], 'overallOfficials': [{'name': 'Gamze Teskereci', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Akdeniz University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akdeniz University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}