Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2025-12-30 @ 4:50 AM
Study NCT ID:
NCT05531357
Status:
COMPLETED
Last Update Posted:
2024-05-17
First Post:
2022-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physiologic Mechanisms Underlying Ovarian Follicular Waves During the Menstrual Cycle
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D018962', 'term': 'Phlebotomy'}], 'ancestors': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Dried blood spots, serum frozen at -80 C and dried urine spot samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-15', 'studyFirstSubmitDate': '2022-08-29', 'studyFirstSubmitQcDate': '2022-09-02', 'lastUpdatePostDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antral follicle diameter', 'timeFrame': 'One menstrual cycle (21-35 days) per volunteer', 'description': 'Daily diameters of individual follicles ≥ 2mm from ultrasound examination'}, {'measure': 'Antral follicle count', 'timeFrame': 'One menstrual cycle (21-35 days) per volunteer', 'description': 'Daily count of the number of follicles \\>2 mm from ultrasound examination'}, {'measure': 'Follicle stimulating hormone (FSH) serum level', 'timeFrame': 'One menstrual cycle (21-35 days) per volunteer', 'description': 'Daily measurements of FSH in IU/L'}, {'measure': 'Luteinizing hormone (LH) serum level', 'timeFrame': 'One menstrual cycle (21-35 days) per volunteer', 'description': 'Daily measurements of LH in IU/L'}, {'measure': 'Estradiol serum level', 'timeFrame': 'One menstrual cycle (21-35 days) per volunteer', 'description': 'Daily measurements of estradiol in pg/mL'}, {'measure': 'Progesterone serum level', 'timeFrame': 'One menstrual cycle (21-35 days) per volunteer', 'description': 'Daily measurements of progesterone in ng/mL'}, {'measure': 'Anti-mullerian hormone (AMH) serum level', 'timeFrame': 'One menstrual cycle (21-35 days) per volunteer', 'description': 'Daily measurements of AMH in ng/mL'}, {'measure': 'Inhibin A serum level', 'timeFrame': 'One menstrual cycle (21-35 days) per volunteer', 'description': 'Daily measurements of inhibin A in pg/mL'}, {'measure': 'Inhibin B serum level', 'timeFrame': 'One menstrual cycle (21-35 days) per volunteer', 'description': 'Daily measurements of inhibin B in pg/mL'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ovarian follicles', 'ovulation'], 'conditions': ['Reproductive Issues']}, 'referencesModule': {'references': [{'pmid': '12849812', 'type': 'BACKGROUND', 'citation': 'Baerwald AR, Adams GP, Pierson RA. A new model for ovarian follicular development during the human menstrual cycle. Fertil Steril. 2003 Jul;80(1):116-22. doi: 10.1016/s0015-0282(03)00544-2.'}, {'pmid': '12748128', 'type': 'BACKGROUND', 'citation': 'Baerwald AR, Adams GP, Pierson RA. Characterization of ovarian follicular wave dynamics in women. Biol Reprod. 2003 Sep;69(3):1023-31. doi: 10.1095/biolreprod.103.017772. Epub 2003 May 14.'}]}, 'descriptionModule': {'briefSummary': 'The research aims to characterize changes in ovarian and pituitary hormones associated with the development of ovarian follicular waves during the human menstrual cycle.', 'detailedDescription': "Our laboratory's previous research has demonstrated that multiple waves of ovarian follicles develop throughout the menstrual cycle. Approximately 2/3 of women develop 2 follicle waves throughout their cycle while the remainder exhibit 3 waves of follicle growth (1,2). This study is to follow up on those findings to determine how pituitary and ovarian hormones regulate the development of follicle waves in women, with a combination of ultrasound scans and blood and urine sampling to characterize how follicles grow during the menstrual cycle in 50 women of reproductive age. Changes in follicle growth across the cycle will be compared with changes in hormone production.\n\nThe new findings will be essential for improving understanding of female reproduction, with clinical applications in contraception, fertility and menopausal care for women across their reproductive lifespan."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Volunteers who respond to advertisements placed in the community, local offices and the University of Saskatchewan's website", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy biological females\n* Regular menstrual cycles (21-35 days)\n\nExclusion Criteria:\n\n* BMI \\<18 or \\>30\n* Pregnancy\n* Breastfeeding mothers\n* Current infertility\n* History of hysterectomy or oophorectomy\n* Reproductive health issues that can interfere with study outcomes\n* Smoking\n* Metabolic syndrome (blood pressure, fasting glucose, fasting insulin and serum lipids measured to assess eligibility)\n* Not on any hormonal medication that affects reproduction (including hormonal contraception)\n* Hyperprolactinemia\n* Abnormal thyroid stimulating hormone assay'}, 'identificationModule': {'nctId': 'NCT05531357', 'briefTitle': 'Physiologic Mechanisms Underlying Ovarian Follicular Waves During the Menstrual Cycle', 'organization': {'class': 'OTHER', 'fullName': 'University of Saskatchewan'}, 'officialTitle': 'Physiologic Mechanisms Underlying Ovarian Follicular Waves During the Menstrual Cycle', 'orgStudyIdInfo': {'id': 'Bio 2080'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Transvaginal ultrasound scans', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Finger-prick blood sampling for dried blood spots', 'Urine sampling', 'Venipunctures'], 'description': 'Transvaginal ultrasound scans to map ovarian follicle growth and ovulation, finger-prick blood sampling for dried blood spot (DBS) hormonal assays and urine sampling for hormone metabolites, every consecutive day for an interovulatory interval.\n\nWeekly venipuncture samples will be taken for standard ELISA hormonal assays. The hormones of interest are FSH, LH, estradiol, progesterone, AMH, inhibins A and B, GDF-9 and BMP-15.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S7N 5A2', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'University of Saskatchewan', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'overallOfficials': [{'name': 'Angela R Baerwald, PhD,MD,CCFP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Saskatchewan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Saskatchewan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ansh Labs', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Angela Baerwald', 'investigatorAffiliation': 'University of Saskatchewan'}}}}