Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2026-01-02 @ 2:30 PM
Study NCT ID:
NCT03433768
Status:
COMPLETED
Last Update Posted:
2018-02-15
First Post:
2018-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Androgen Receptor mRNA Expression is Positively Associated With Live Birth in Women Undergoing IVF Independently of the Type of Ovarian Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D060888', 'term': 'Real-Time Polymerase Chain Reaction'}], 'ancestors': [{'id': 'D016133', 'term': 'Polymerase Chain Reaction'}, {'id': 'D021141', 'term': 'Nucleic Acid Amplification Techniques'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}, 'targetDuration': '4 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-08', 'studyFirstSubmitDate': '2018-01-31', 'studyFirstSubmitQcDate': '2018-02-08', 'lastUpdatePostDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Androgen Receptor mRNA expression', 'timeFrame': 'day one, six and ten of ovarian stimulation', 'description': 'The expression of androgen receptor mRNA in peripheral blood of normal and poor responders level of expression in peripheral blood according to the Delta-Delta-Ct (ddCt) Algorithm.\n\nPercentage of increase?'}], 'secondaryOutcomes': [{'measure': 'Serum LH levels in peripheral blood of normal and poor responders', 'timeFrame': 'day one, six and ten of ovarian stimulation', 'description': 'level of hormone in international unit.'}, {'measure': 'Serum progesterone levels in peripheral blood of normal and poor responders.', 'timeFrame': 'day one, six and ten of ovarian stimulation', 'description': 'level of hormone in international unit.'}, {'measure': 'Serum estradiol levels in peripheral blood of normal and poor responders', 'timeFrame': 'day one, six and ten of ovarian stimulation', 'description': 'level of hormone in international unit.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Androgen Receptor Gene Overexpression', 'Normal Responders', 'Poor Ovarian Response', 'Bologna Criteria']}, 'descriptionModule': {'briefSummary': "AR is a steroid hormone receptor that regulates various genes' expression and affects cellular proliferation and differentiation. Androgens interact with AR, exert their paracrine action on granulosa cells and regulate gonadotropin synthesis, follicle development, oocyte maturation and corpus luteum function. Estrogens increase AR mRNA and testosterone binding site in uterine endometrium and leiomyoma. In human cancer cells, low estradiol increases AR levels, suggesting the estrogen/androgen ratio as a predictor of sex steroid response. AR mRNA expression is, also, regulated by progesterone. Although AR mRNA is expressed in the female reproductive tissues, its expression has never been studied in peripheral blood."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Forty normal responders and twenty-seven poor responders according to Bologna criteria, undergoing IVF/ICSI. Ovarian stimulation was performed with 200 IU recombinant follicle stimulating hormone (rFSH) and gonadotrophin releasing hormone (GnRH) antagonists. Triggering of final oocyte maturation was performed by recombinant human chorionic gonadotrophic (rhCG)', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with poor ovarian response according to bologna criteria\n\n 1. Advanced maternal age (≥40 years) or any other risk factor for poor ovarian response\n 2. A previous poor ovarian response (≤3 oocytes with a conventional stimulation protocol)\n 3. Abnormal ovarian reserve test, (AFC ˂5-7 follicles or AMH ˂0.5-1.1 ng/ml).\n* Women with normal ovarian response with normal menstrual cycles, normal astral follicle count and normal hormonal assay.\n\nExclusion Criteria:\n\n* Not more than 43 years old.\n* No history of malignancies, endometriosis or polycystic ovary syndrome.\n* Underlying genetic cause of infertility\n* History of severe cardiac, hepatic or renal disease.\n* History of systemic disease or treatment during the last three (3) months\n* Participation in another interventional study and a likelihood of being unavailable for follow-up.'}, 'identificationModule': {'nctId': 'NCT03433768', 'briefTitle': 'Androgen Receptor mRNA Expression is Positively Associated With Live Birth in Women Undergoing IVF Independently of the Type of Ovarian Response', 'organization': {'class': 'OTHER', 'fullName': 'Aristotle University Of Thessaloniki'}, 'officialTitle': 'Androgen Receptor (AR) mRNA Expression is Positively Associated With Live Birth in Women Undergoing In-vitro Fertilization Independently of the Type of Ovarian Response', 'orgStudyIdInfo': {'id': 'UHR 13'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'poor responders', 'interventionNames': ['Genetic: Real time PCR']}, {'label': 'normal responders', 'interventionNames': ['Genetic: Real time PCR']}], 'interventions': [{'name': 'Real time PCR', 'type': 'GENETIC', 'description': 'We take peripheral blood sample at day one, six and ten of ovarian stimulation and measure mRNA expression of androgen receptor.', 'armGroupLabels': ['normal responders', 'poor responders']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aristotle University Of Thessaloniki', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'E.M. Kolibianakis', 'investigatorAffiliation': 'Aristotle University Of Thessaloniki'}}}}