Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2026-02-26 @ 2:14 AM
Study NCT ID:
NCT03306459
Status:
UNKNOWN
Last Update Posted:
2017-10-20
First Post:
2017-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychological Traits, Sexuality and Quality of Life in Patients With Polycystic Ovary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D019529', 'term': 'Sexuality'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'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'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-01-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-19', 'studyFirstSubmitDate': '2017-10-05', 'studyFirstSubmitQcDate': '2017-10-05', 'lastUpdatePostDateStruct': {'date': '2017-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Biochemical markers', 'timeFrame': 'january 9th 2018-january 9th 2019', 'description': 'Results of blood tests including biochemistry and hormones analysis'}, {'measure': 'Phenotipical traits', 'timeFrame': 'january 9th 2018-january 9th 2019', 'description': 'Record of hirsutism, acne, alopecia, and other hyperandrogenic symptoms'}], 'primaryOutcomes': [{'measure': 'Quality of Life', 'timeFrame': 'january 9th 2018-january 9th 2019', 'description': 'results of SF-36'}], 'secondaryOutcomes': [{'measure': 'Sexuality', 'timeFrame': 'january 9th 2018-january 9th 2019', 'description': 'Results of FSFI'}, {'measure': 'Psychological distress', 'timeFrame': 'january 9th 2018-january 9th 2019', 'description': 'Results of Symptom Checklist-90-Revision (SCL-90-R)'}, {'measure': 'Anger and aggressiveness', 'timeFrame': 'january 9th 2018-january 9th 2019', 'description': 'results of State-Trait-Anger-Expression-Inventory, version 2 (STAXI-2)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PCOS', 'Quality of life', 'Sexuality', 'Psychological traits'], 'conditions': ['Polycystic Ovary Syndrome']}, 'referencesModule': {'references': [{'pmid': '33763818', 'type': 'DERIVED', 'citation': 'Naumova I, Castelo-Branco C, Casals G. Psychological Issues and Sexual Function in Women with Different Infertility Causes: Focus on Polycystic Ovary Syndrome. Reprod Sci. 2021 Oct;28(10):2830-2838. doi: 10.1007/s43032-021-00546-x. Epub 2021 Mar 24.'}]}, 'descriptionModule': {'briefSummary': 'A prospective assessment of psychological characteristics, quality of life and sexuality in naïve patients.', 'detailedDescription': 'This project with PCOS patients include an assessment of quality of life and sexuality in naïve patients.\n\nHypothesizing that PCOS women would show higher rates of psychological alterations, this study is aimed to investigate the association between polycystic ovary syndrome (PCOS) and psychological disturbances, including anger and to analyze whether the biochemical/phenotypical features of PCOS may play a role in the type and severity of psychological disorders.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The authors will select 30 PCOS patients who met the more strict and conservative Rotterdam diagnostic criteria (Rotterdam phenotype A)', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nPCOS patients without gestational desire who met the following criteria\n\n* Oligomenorrhea (cycles lasting \\>35 days) or amenorrhea (no periods in 6 months)\n* Hyperandrogenemia/hyperandrogenism Hirsutism Ferriman-Gallwey score \\> 12 Obvious acne or pronounced alopecia Androgen levels over normal female range\n\nExclusion Criteria:\n\n* Prior psychiatric diagnosis\n* Current use of psychiatric medications\n* Difficulties with language comprehension in case of non-nationals.\n* Yatrogenic hirsutism,\n* Other endocrine deseases with hyperandrogenism or that may influence the final results Ovarian or adrenal neoplasia Prolactinoma Cushing's syndrome Congenital adrenal hyperplasia Diabetes mellitus Thromboembolic disease\n* Patients who had received any drug therapy for hirsutism over the last 6 months"}, 'identificationModule': {'nctId': 'NCT03306459', 'briefTitle': 'Psychological Traits, Sexuality and Quality of Life in Patients With Polycystic Ovary Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'Hospital Clínic Barcelona', 'orgStudyIdInfo': {'id': 'B/2017/0614'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1/PCOS', 'description': 'The authors will select 30 PCOS patients who met the more strict and conservative Rotterdam diagnostic criteria (Rotterdam phenotype A) which include the presence of oligo-anovulation (cycles lasting \\>35 days or amenorrhea) and hyperandrogenemia /hyperandrogenism (hirsutism or obvious acne or pronounced alopecia). All patients should have bilateral polycystic ovaries morphology on ultrasound. Additionally, the authors have decided to enroll PCOS patients that are all without pregnancy desire at the moment they fill out the questionnaires, in order to control for the potential confounding role of infertility on psychological outcomes. Different pituitary, adrenal, ovarian, thyroid or metabolic diseases will be excluded', 'interventionNames': ['Diagnostic Test: SF-36 (Short Form Health Survey)']}, {'label': '2/CONTROL', 'description': 'The authors will enroll a control group of 30 women, age- matched with the PCOS women, from consecutive women controlled in the same outpatient clinic who met the following inclusion criteria: history of irregular menstrual cycle in absence of severe gynecologic and non-gynecologic diseases. This PCOS sample will be entirely constituted by women with no pregnancy desire; therefore, with the aim to limit the potential effect of the unfulfilled wish to conceive in the final results; additionally, infertile women will not admitted into the control group.', 'interventionNames': ['Diagnostic Test: SF-36 (Short Form Health Survey)']}], 'interventions': [{'name': 'SF-36 (Short Form Health Survey)', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Female Sexual Function Index; Symptom Checklist-90-R; State-Trait-Anger-Expression-Inventory'], 'description': 'Symptom Checklist-90-Revision (SCL-90-R): self-report questionnaire of 90 items on a 5-point Likert scale clustered in 9 primary scales (somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation and psychoticism).\n\nState-Trait-Anger-Expression-Inventory, version 2 (STAXI-2): self-report questionnaire of 57-items on a 4-point scale distributed in different dimensions: State-Anger, Trait-Anger Expression Anger (in-out) and Anger Control (in-out) Short Form Health Survey (SF-36), an instrument composed by 8 subscales: Physical Functioning, Physical Role Function, Bodily Pain, General Health, Vitality, Social Functioning, Emotional Role Function and Mental Health.\n\nFemale Sexual Function Index (FSFI) a 19-item self-report measure of female sexual function providing scores on 6 domains (desire, arousal, lubrication, orgasm, satisfaction, pain) as well as a total score.', 'armGroupLabels': ['1/PCOS', '2/CONTROL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'contacts': [{'name': 'Camil Castelo-Branco, MD PhD', 'role': 'CONTACT', 'email': 'ccastelo@clinic.cat', 'phone': '+342275436'}, {'name': 'Juliia Naumova, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Clínic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Camil Castelo-Branco, MD PhD', 'role': 'CONTACT', 'email': 'ccastelo@clinic.cat', 'phone': '1679999037'}, {'name': 'Camil Castelo-Branco', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Camil Castelo-Branco, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Clínic. University of Barcelona'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Camil Castelo-Branco', 'investigatorAffiliation': 'Hospital Clinic of Barcelona'}}}}