Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-27 @ 5:03 PM
Study NCT ID:
NCT05928650
Status:
COMPLETED
Last Update Posted:
2023-08-31
First Post:
2023-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Menstrual Function Among Sprinters, Long Marathon Runners, and Non-Athletic Females
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008599', 'term': 'Menstruation Disturbances'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-30', 'studyFirstSubmitDate': '2023-06-26', 'studyFirstSubmitQcDate': '2023-06-26', 'lastUpdatePostDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum estradiol level', 'timeFrame': '3 months', 'description': 'Blood samples were obtained on the 2nd day of the menstrual cycle at 10.00 a.m. following overnight fasting and rest. The athletic females were instructed to refrain from performing strenuous exercise on the day of sampling. Blood samples were separated and stored at -80°C till analysis of serum estradiol levels. Serum estradiol levels were measured to evaluate the menstrual function. The manufacturer indicated the following reference intervals for healthy females: Estradiol 40-350 pg/ml.'}, {'measure': 'Menstrual history characteristics', 'timeFrame': '3 months', 'description': 'The age at menarche (in years), the number of menstrual cycles in the past year, and the length of menstrual cycles (in days) were collected through a self-administered questionnaire to evaluate the menstrual status of each female participant.'}, {'measure': 'Age of participation to sport', 'timeFrame': '3 months', 'description': 'It was taken in years from each female athlete through a self-administered questionnaire.'}, {'measure': 'Weekly training workload', 'timeFrame': '3 months', 'description': 'It was taken in hours per week from each female athlete through a self-administered questionnaire.'}, {'measure': 'Training experience', 'timeFrame': '3 months', 'description': 'The training experience of the athlete was then calculated by subtracting her age of participation in sport from her chronological age.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Menstrual function', 'Serum estradiol levels', 'Sprinters', 'Long Marathon Runners', 'Non-Athletic Females'], 'conditions': ['Menstruation Disturbances']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare between sprinters and long marathon in menstrual characteristics and serum estradiol level.', 'detailedDescription': "Menstrual function and dysfunction conversations have long been stigmatized both in the general population and in sport settings (O'Flynn, 2006). However, Discussions of menstruation in the sport context often focuses on the impact of physical menstrual symptoms and dysfunction on activities such as training and sport performance (Bruinvels et al., 2016; Knowles et al., 2019). In addition, no study had been compare between sprinters and long-marathon runners in menstrual characteristics and estradiol level. Therefore, the purpose of this study to compare between sprinters and long marathon in menstrual characteristics and serum estradiol level."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '16 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Egyptian sprinters, long marathon runners, and non-athletic females', 'genderDescription': 'Participant eligibility is based on self-representation of gender identity.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Virginal females.\n* Their age ranged from 16 to 19years.\n* All females had the same socio-economic status.\n\nFor athletic groups only:\n\n* They have been starting the practice of sport at least one year before the onset of menarche.\n\nExclusion Criteria:\n\n* Females who had been used oral contraceptives or any hormonal treatment in the previous six months.\n* Smoking.\n* History of chronic disease.\n* Having any psychiatric problems.\n\nFor athletic groups only:\n\n* injured females who were absent from training for at least three months.'}, 'identificationModule': {'nctId': 'NCT05928650', 'briefTitle': 'Comparison of Menstrual Function Among Sprinters, Long Marathon Runners, and Non-Athletic Females', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Comparison of Menstrual Function Among Sprinters, Long Marathon Runners, and Non-athletic Females: An Observational Study', 'orgStudyIdInfo': {'id': 'P.T.REC/012/004550'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sprinters', 'description': 'Sprinters', 'interventionNames': ['Other: Evaluation of menstrual function']}, {'label': 'Long marathon runners', 'description': 'Long marathon runners', 'interventionNames': ['Other: Evaluation of menstrual function']}, {'label': 'Non-athletic Females', 'description': 'Non-athletic Females', 'interventionNames': ['Other: Evaluation of menstrual function']}], 'interventions': [{'name': 'Evaluation of menstrual function', 'type': 'OTHER', 'description': 'Evaluation of serum estradiol levels and menstrual history characteristics between sprinters, long marathon runners and non-athletes.', 'armGroupLabels': ['Long marathon runners', 'Non-athletic Females', 'Sprinters']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'country': 'Egypt', 'facility': 'Faculty of Physical therapy, Cairo University', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Doaa Osman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Department of Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt."}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Doaa A. Osman', 'investigatorAffiliation': 'Cairo University'}}}}