Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 11:10 PM
Study NCT ID:
NCT06105593
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-13
First Post:
2023-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Balneotherapy and Physiotherapy Treatment in Female Infertility: a Retrospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}, {'id': 'D007246', 'term': 'Infertility'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 577}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-12', 'studyFirstSubmitDate': '2023-10-17', 'studyFirstSubmitQcDate': '2023-10-26', 'lastUpdatePostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'successful conception', 'timeFrame': '12 months', 'description': 'Assessing with questionnaire. The participants are asked to answer the question whether they had a positive pregnancy test within 1 year after the complex balneotherapy and physiotherapy treatment at the Harkany Thermal Rehabilitation Center.'}], 'secondaryOutcomes': [{'measure': 'successful delivery', 'timeFrame': '12 months', 'description': 'Assessing with questionnaire. We ask the participants, if they managed to get pregnant within 1 year after the complex balneo and physiotherapy treatment to answer the question about what the outcome of their pregnancy was (for example: childbirth, miscarriage, stillbirth, etc.).'}, {'measure': 'the effect of the treatments on successful conception in different causes of infertility', 'timeFrame': '12 months', 'description': 'Assessing with questionnaire and statistical analysis. Based on the answers to the questionnaire, we will use statistical analysis to investigate the proportion of successful pregnancies after the complex balneotherapy and physiotherapy treatment in the case of the different pathologies underlying infertility.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Balneotherapy, Physiotherapy, Questionnaire, Infertility'], 'conditions': ['Infertility, Female']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to assess the effect of complex balneotherapy and physiotherapy treatment among infertile women treated in the Harkany Thermal Rehabilitation Center between July 01, 2007 and December 31, 2021. The main questions it aims to answer are:\n\n* To what extent can the complex balneotherapy and physiotherapy treatment be an effective additional therapy in female infertility?\n* What are the clinical changes behind infertility that can be helped by the complex balneotherapy and physiotherapy treatment? Participants will be asked to answer a questionnaire that we have prepared.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'In the period between July 1, 2007 and December 31, 2021, received a 3-week complex balneotherapy and physiotherapy treatment at the Harkany Thermal Rehabilitation Center in inpatient care', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female gender\n* Diagnosed primary or secondary infertility\n\nExclusion Criteria:\n\n* Lack of cooperation'}, 'identificationModule': {'nctId': 'NCT06105593', 'briefTitle': 'Effect of Balneotherapy and Physiotherapy Treatment in Female Infertility: a Retrospective Study', 'organization': {'class': 'OTHER', 'fullName': 'Harkány Thermal Rehabilitation Centre'}, 'officialTitle': 'Combined Effect of Balneotherapy and Physiotherapy Treatment in Female Infertility at Harkany Thermal Rehabilitation Centre: a Retrospective Study', 'orgStudyIdInfo': {'id': '9665-PTE 2023.'}}, 'contactsLocationsModule': {'locations': [{'zip': '7815', 'city': 'Harkány', 'country': 'Hungary', 'facility': 'Harkany Thermal Rehabilitation Center', 'geoPoint': {'lat': 45.85002, 'lon': 18.23668}}], 'overallOfficials': [{'name': 'Eszter Ambrus', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harkany Thermal Rehabilitation Center'}, {'name': 'Nóra Nusser', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Harkany Thermal Rehabilitacion Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harkány Thermal Rehabilitation Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}