Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-27 @ 6:13 PM
Study NCT ID:
NCT02999568
Status:
UNKNOWN
Last Update Posted:
2016-12-21
First Post:
2016-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Exercise on Ovarian Reserve
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-18', 'studyFirstSubmitDate': '2016-12-15', 'studyFirstSubmitQcDate': '2016-12-18', 'lastUpdatePostDateStruct': {'date': '2016-12-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Levels of anti-mullerian hormone', 'timeFrame': '3 days after period'}, {'measure': 'Number of Antral Follicle Count', 'timeFrame': '3 days after period'}], 'secondaryOutcomes': [{'measure': 'Levels of Follicle-stimulating hormone', 'timeFrame': '3 days after period'}, {'measure': 'levels fo Luteinizing hormone', 'timeFrame': '3 days after period'}, {'measure': 'Levels of progesterone', 'timeFrame': '3 days after period'}, {'measure': 'Levels of estradiol', 'timeFrame': '3 days after period'}, {'measure': 'Levels of Thyroid-stimulating hormone', 'timeFrame': '3 days after period'}, {'measure': 'Levels of leptin', 'timeFrame': '3 days after period'}, {'measure': 'Menstrual duration', 'timeFrame': '3 days after period'}, {'measure': 'frequency of bleeding in every menstruation', 'timeFrame': '3 days after period'}, {'measure': 'amount of bleeding in every menstruation', 'timeFrame': '3 days after period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Physical Exercise']}, 'referencesModule': {'references': [{'pmid': '7823386', 'type': 'BACKGROUND', 'citation': 'Pate RR, Pratt M, Blair SN, Haskell WL, Macera CA, Bouchard C, Buchner D, Ettinger W, Heath GW, King AC, et al. Physical activity and public health. A recommendation from the Centers for Disease Control and Prevention and the American College of Sports Medicine. JAMA. 1995 Feb 1;273(5):402-7. doi: 10.1001/jama.273.5.402.'}, {'pmid': '10740759', 'type': 'BACKGROUND', 'citation': 'Clapp JF 3rd. Exercise during pregnancy. A clinical update. Clin Sports Med. 2000 Apr;19(2):273-86. doi: 10.1016/s0278-5919(05)70203-9.'}, {'pmid': '21920880', 'type': 'BACKGROUND', 'citation': 'Duckitt K. Exercise during pregnancy. BMJ. 2011 Sep 15;343:d5710. doi: 10.1136/bmj.d5710. No abstract available.'}, {'pmid': '11880759', 'type': 'BACKGROUND', 'citation': 'Rich-Edwards JW, Spiegelman D, Garland M, Hertzmark E, Hunter DJ, Colditz GA, Willett WC, Wand H, Manson JE. Physical activity, body mass index, and ovulatory disorder infertility. Epidemiology. 2002 Mar;13(2):184-90. doi: 10.1097/00001648-200203000-00013.'}, {'pmid': '20199120', 'type': 'BACKGROUND', 'citation': 'Oosthuyse T, Bosch AN. The effect of the menstrual cycle on exercise metabolism: implications for exercise performance in eumenorrhoeic women. Sports Med. 2010 Mar 1;40(3):207-27. doi: 10.2165/11317090-000000000-00000.'}, {'pmid': '8567797', 'type': 'BACKGROUND', 'citation': 'Clark AM, Ledger W, Galletly C, Tomlinson L, Blaney F, Wang X, Norman RJ. Weight loss results in significant improvement in pregnancy and ovulation rates in anovulatory obese women. Hum Reprod. 1995 Oct;10(10):2705-12. doi: 10.1093/oxfordjournals.humrep.a135772.'}, {'pmid': '8921059', 'type': 'BACKGROUND', 'citation': 'Hollmann M, Runnebaum B, Gerhard I. Effects of weight loss on the hormonal profile in obese, infertile women. Hum Reprod. 1996 Sep;11(9):1884-91. doi: 10.1093/oxfordjournals.humrep.a019512.'}, {'pmid': '17012457', 'type': 'BACKGROUND', 'citation': 'Morris SN, Missmer SA, Cramer DW, Powers RD, McShane PM, Hornstein MD. Effects of lifetime exercise on the outcome of in vitro fertilization. Obstet Gynecol. 2006 Oct;108(4):938-45. doi: 10.1097/01.AOG.0000235704.45652.0b.'}, {'pmid': '24524834', 'type': 'BACKGROUND', 'citation': 'Evenson KR, Calhoun KC, Herring AH, Pritchard D, Wen F, Steiner AZ. Association of physical activity in the past year and immediately after in vitro fertilization on pregnancy. Fertil Steril. 2014 Apr;101(4):1047-1054.e5. doi: 10.1016/j.fertnstert.2013.12.041. Epub 2014 Feb 10.'}, {'pmid': '22287447', 'type': 'BACKGROUND', 'citation': 'Masse LC, de Niet JE. Sources of validity evidence needed with self-report measures of physical activity. J Phys Act Health. 2012 Jan;9 Suppl 1:S44-55. doi: 10.1123/jpah.9.s1.s44.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine how different levels of physical activity impact the ovarian reserve during the pre-menopausal period', 'detailedDescription': "Two groups are included:\n\n1. The study group: women between 20-35 years of age who practice high level of physical activity, as defined by International Physical Activity Questionnaire , for the past 3 years\n2. The control group: women between 20-35 years of age who practice low level of physical activity, as defined by International Physical Activity Questionnaire , for the past 3 years\n\nWomen who meet the criteria for inclusion for will be recruited to the study after signing a consent form. Recruitment will be done through sport centers. The control group will include women being examined in gynecologic emergency department, after signing a consent form, if they meet the control group's inclusion criteria. These women will be asked to fulfill the International Physical Activity Questionnaire and additional questionnaire regarding relevant demographic and medical information (see below). Blood samples to anti-mullerian hormone , leptin, and hormonal profile will be obtained in day 3 of menstruation. Ultrasound will be performed to measure Antral Follicular count and ovarian blood flow.\n\nData collection:\n\n1. Demographic information on age, weight, height, BMI, marital status\n2. Medical information regarding chronic diseases and medications\n3. Obstetrical history\n4. Information regarding physical activities in the version of International Physical Activity Questionnaire .\n5. Information about menstrual behavior: irregularity (yes/no) frequency (less than 21 days between 21-35 days, over 35 days), menstrual duration (less than 3 days 3-7 days, or over 7 days) bleeding amount according to the number of pads per day (up to 1, 2, 4 or 5 pads).\n6. Hormonal profile - Follicle-stimulating hormone , Luteinizing hormone , progesterone, Estradiol, Thyroid-stimulating hormone .\n7. Antral Follicle Count, Anti-mullerian hormone\n8. Leptin levels -reflecting metabolic changes."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Control group - Recruitment will be done through Gynocologis tEmergency Experimental group - Recruitment will be done through sport centers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nStudy group:\n\n1. Women between 20-35 years of age who practice high level of physical activity, as defined by International Physical Activity Questionnaire, for the past 3 years\n2. BMI 18-25\n3. Regular menstruation\n\nControl group:\n\n1. Women between 20-35 years of age who practice low level of physical activity, as defined by International Physical Activity Questionnaire, for the past 3 years\n2. BMI 18-25\n3. Regular menstruation\n\nExclusion Criteria:\n\n1\\. Polycystic ovary syndrome 2. Endometriosis 3. Diabetes 4. Hyper/hypothyroidism 5. BMI\\>25, BMI\\<18 6. Active or past eating disorder\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02999568', 'briefTitle': 'The Effect of Exercise on Ovarian Reserve', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'Open Study to Examine How Different Levels of Physical Activity Impact the Ovarian Reserve During the Pre-menopausal Period', 'orgStudyIdInfo': {'id': 'Meir Medical Center - Sport'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental', 'description': 'Women who practice high level of physical activity, as defined by International Physical Activity Questionnaire, for the past 3 years', 'interventionNames': ['Other: Physical exercise']}, {'label': 'Control group', 'description': 'Women who practice low level of physical activity, as defined by International Physical Activity Questionnaire, for the past 3 years'}], 'interventions': [{'name': 'Physical exercise', 'type': 'OTHER', 'description': 'Women who practice high level of physical activity, as defined by International Physical Activity Questionnaire, for the past 3 years will be recruited. These women will will be asked to fulfill the International Physical Activity Questionnaire and additional questionnaire regarding relevant demographic and medical information. Blood samples to anti-mullerian hormone , leptin, and hormonal profile will be obtained in day 3 of menstruation. Ultrasound will be performed to measure Antral Follicular count and ovarian blood flow', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Amir Wiser, MD', 'role': 'CONTACT', 'email': 'Amir.Wiser@clalit.org.il', 'phone': '07297472901'}, {'name': 'Helsinki Committee MMC', 'role': 'CONTACT', 'phone': '97297471588'}], 'overallOfficials': [{'name': 'Yael Pasternak, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Meir Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Yael Pasternak', 'investigatorAffiliation': 'Meir Medical Center'}}}}