Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2026-02-02 @ 11:58 AM
Study NCT ID:
NCT04539392
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-17
First Post:
2020-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Sexuality of the Infertile Couple
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2020-08-31', 'studyFirstSubmitQcDate': '2020-08-31', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sexuality of the female of the couple', 'timeFrame': '2 weeks after inclusion (start of MAP)', 'description': 'Female sexual function index: The total score is between 2 and 36 with sexual dysfunction indicated for scores below 26.55'}, {'measure': 'Sexuality of the female of the couple', 'timeFrame': '1 month after ovarian ponction (end of MAP)', 'description': 'Female sexual function index: The total score is between 2 and 36 with sexual dysfunction indicated for scores below 26.55'}, {'measure': 'Sexuality of the male of the couple', 'timeFrame': '2 weeks after inclusion (start of MAP)', 'description': 'Male Sexual Health Questionnaire'}, {'measure': 'Sexuality of the male of the couple', 'timeFrame': '1 month after ovarian ponction (end of MAP)', 'description': 'Male Sexual Health Questionnaire'}, {'measure': 'Ejactulation of the male of the couple', 'timeFrame': '2 weeks after inclusion (start of MAP)', 'description': 'Premature Ejaculation Profile'}, {'measure': 'Ejactulation of the male of the couple', 'timeFrame': '1 month after ovarian ponction (end of MAP)', 'description': 'Premature Ejaculation Profile'}], 'secondaryOutcomes': [{'measure': 'Sexuality of the female of the couple', 'timeFrame': '1 month after ovarian ponction (end of MAP)', 'description': 'Female sexual function index: The total score is between 2 and 36 with sexual dysfunction indicated for scores below 26.55'}, {'measure': 'Sexuality of the male of the couple', 'timeFrame': '1 month after ovarian ponction (end of MAP)', 'description': 'Male Sexual Health Questionnaire'}, {'measure': 'Body satisfaction and global self-perception of both members of the couple', 'timeFrame': '2 weeks after inclusion (start of MAP)', 'description': 'Questionnaire de satisfaction corporelle et de perception globale de soi (QSCPGS): total score ranges from -100 to +100.'}, {'measure': 'Body satisfaction and global self-perception of both members of the couple', 'timeFrame': '1 month after ovarian ponction (end of MAP)', 'description': 'Questionnaire de satisfaction corporelle et de perception globale de soi (QSCPGS): total score ranges from -100 to +100.'}, {'measure': 'Relationship satisfaction of both members of the couple', 'timeFrame': '2 weeks after inclusion (start of MAP)', 'description': 'Dyadic Adjustment Scale-16 Distress if score less than 92 and without distress if the score is higher than 107'}, {'measure': 'Relationship satisfaction of both members of the couple', 'timeFrame': '1 month after ovarian ponction (end of MAP)', 'description': 'Dyadic Adjustment Scale-16 Distress if score less than 92 and without distress if the score is higher than 107'}, {'measure': 'Self-esteem of both members of the couple', 'timeFrame': '2 weeks after inclusion (start of MAP)', 'description': 'Rosenberg self-esteem scale: The score is between 10 and 40. A score below 25 indicates very low self-esteem. A score between 25 and 31 indicates low self-esteem. A score between 31 and 34 indicates average self-esteem. A score between 34 and 39 indicates strong self-esteem. A score above 39 indicates very high self-esteem.'}, {'measure': 'Self-esteem of both members of the couple', 'timeFrame': '1 month after ovarian ponction (end of MAP)', 'description': 'Rosenberg self-esteem scale: The score is between 10 and 40. A score below 25 indicates very low self-esteem. A score between 25 and 31 indicates low self-esteem. A score between 31 and 34 indicates average self-esteem. A score between 34 and 39 indicates strong self-esteem. A score above 39 indicates very high self-esteem.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': "The study hypothesis is that infertile couples experience an impact of their sexuality impacted during the diagnostic process carried out as part of the medically assisted procreation assessment, and also by the announcement of the possible cause of the couple's infertility. It is also conceivable that a disorder of the couple's sexuality forms the origin of, or is a contributor to, infertility."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '80 heterosexual infertile couples (according to the WHO definition) followed at the Nîmes University Hospital in the Urology / Gynecology departments.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Couple in which each of the two partners has signed the consent form which is presented separately and independently of their partner.\n* The patient must be a member or beneficiary of a health insurance plan\n* Heterosexual infertile couple (according to the WHO definition) monitored at the Nîmes University Hospital in the urology / gynecology departments.\n\nAdult patient (≥18 years old) and under 43 years old for women, 60 years old for men\n\nExclusion Criteria:\n\n* The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study\n* One member of the couple refuses to sign the consent\n* It is impossible to give the subject informed information\n* The patient is under safeguard of justice or state guardianship\n* Patient without good level of written and spoken French'}, 'identificationModule': {'nctId': 'NCT04539392', 'acronym': 'INFEXO', 'briefTitle': 'Assessment of the Sexuality of the Infertile Couple', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Assessment of the Sexuality of the Infertile Couple: Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'NIMAO/2019-2/SH-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Infertile couple', 'interventionNames': ['Other: Questionnaires on sexuality']}], 'interventions': [{'name': 'Questionnaires on sexuality', 'type': 'OTHER', 'description': 'Panel of questionnaires assessing sexuality, relationship satisfaction, and body image', 'armGroupLabels': ['Infertile couple']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nîmes', 'country': 'France', 'facility': 'CHU de Nimes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': 'Stéphanie Huberlant', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Nimes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}