Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-02-25 @ 9:39 PM
Study NCT ID:
NCT03914859
Status:
UNKNOWN
Last Update Posted:
2019-04-16
First Post:
2019-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IMPACT OF POLYCYCLIC AROMATIC HYDROCARBONS (PAH) ON IN VITRO FERTILIZATION
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005307', 'term': 'Fertilization in Vitro'}], 'ancestors': [{'id': 'D027724', 'term': 'Reproductive Techniques, Assisted'}, {'id': 'D012099', 'term': 'Reproductive Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The groups will be defined according to the urinary level of 1-hydroxypyrene, the most sensitive biomarker for PAH exposure. A threshold of 0.1 μmol / mol of creatinine was determined according to the INRS.\n\nIt corresponds to the 90th percentile value for non-smokers not occupationally and nutritionally exposed. The reference value in the general population is \\<0.51 μg / g creatinine, and in smokers \\<0.3 μmol / mol creatinine.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2022-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-11', 'studyFirstSubmitDate': '2019-04-11', 'studyFirstSubmitQcDate': '2019-04-11', 'lastUpdatePostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'expired CO', 'timeFrame': '72 hours', 'description': 'The night before the IVF, a urine sample will be collected from both members of the couple, according to the protocol published by the team Partner 2.\n\nOn the day of the IVF, a measurement of the exhaled CO rate will be carried out by the two members of the couple according to the recommendations of the manufacturer.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to highlight a relationship between exposure to PAHs, genotoxic effect biomarkers on spermatozoa and follicular cells, as well as embryonic quality and embryo implantation rates at a given time. IVF attempt. This study therefore analyzes the possibility of using this exposure biomarker as a reliable means of evaluating the quality of gametes in order to estimate the chances of success in IVF.', 'detailedDescription': 'Objective assessment of the effect of environmental and occupational factors on fertility is difficult to establish due to the lack of relevant exposure biomarkers for reporting multi-exposures.\n\nThe main objective of this study is to highlight a relationship between exposure to PAHs, genotoxic effect biomarkers on spermatozoa and follicular cells, as well as embryonic quality and embryo implantation rates at a given time. IVF attempt. This study therefore analyzes the possibility of using this exposure biomarker as a reliable means of evaluating the quality of gametes in order to estimate the chances of success in IVF.\n\nSubsequently, the results of this study will make it possible to personalize and evaluate the effectiveness of the preventive measures put in place upstream of the MPA route by allowing To identify a relationship between PAH exposure and sperm DNA gamete quality in humans, serum AMH concentration and ovarian response to gonadotropic stimulation for IVF in women.\n\nTo highlight a relationship between individual exposures to complex PAH mixtures and infertility.\n\nThe methodology based, on the feminine side, on the analysis of follicular cells makes it possible to study cells close to female gametes within the cumulo-oocyte complex, without losing the chance of pregnancy for the couple.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '36 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Couples whose wife is under 36 and the man under 45 at the time of IVF\n* Regular cycles of 27 to 33 days in women\n* Management of classical IVF (without the use of micro-sperm injection)\n* 1st or 2nd attempt of IVF\n* Signature of informed consent by both partners of the couple\n* Affiliation to a social security scheme or equivalent for both partners of the couple.\n\nExclusion Criteria:\n\n* Refusal to participate in the study of one or both members of the couple\n* No fluency in French\n* History likely to alter the ovarian reserve, endometriosis\n* Uterine or systemic antecedents, likely to affect implantation\n* Andrological antecedents likely to alter fertilization rates\n* History of chemotherapy / radiotherapy\n* Positive plasma viral load for HIV, HCV or HBV in the year prior to inclusion in one of the members of the couple'}, 'identificationModule': {'nctId': 'NCT03914859', 'briefTitle': 'IMPACT OF POLYCYCLIC AROMATIC HYDROCARBONS (PAH) ON IN VITRO FERTILIZATION', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'HAP-REPRO: IMPACT OF POLYCYCLIC AROMATIC HYDROCARBONS (PAH) ON IN VITRO FECONDATION: PARENTAL CELLS WITH EARLY EMBRYONIC QUALITY.', 'orgStudyIdInfo': {'id': '2018-32'}, 'secondaryIdInfos': [{'id': '2018-A00364', 'type': 'REGISTRY', 'domain': 'APHM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Exposed', 'description': 'Urinary level of 1-hydroxypyrene, the most sensitive biomarker of PAH exposure greater than 0.1 μmol / mol creatinine', 'interventionNames': ['Biological: IN VITRO FERTILIZATION']}, {'type': 'OTHER', 'label': 'Not exposed', 'description': 'Urinary level of 1-hydroxypyrene, the most sensitive marker of PAH exposure below 0.1 μmol / mol creatinine', 'interventionNames': ['Biological: IN VITRO FERTILIZATION']}], 'interventions': [{'name': 'IN VITRO FERTILIZATION', 'type': 'BIOLOGICAL', 'description': 'Using exposure biomarker as a reliable means of evaluating gamete quality to estimate the chances of success in in vitro fertilization.', 'armGroupLabels': ['Exposed', 'Not exposed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13354', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jeanne Perrin', 'role': 'CONTACT', 'email': 'jeanne.perrin@univ-amu.fr', 'phone': '+ 33 (0)491 38 29 00'}, {'name': 'Patrick Sudour', 'role': 'CONTACT', 'email': 'promotion.interne@ap-hm.fr', 'phone': '04 91 38 29 03'}], 'facility': 'Assistance des Hôpitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'centralContacts': [{'name': 'Jeanne PERRIN', 'role': 'CONTACT', 'email': 'jeanne.perrin@univ-amu.fr', 'phone': '+ 33 (0)491 38 29 00'}, {'name': 'Patrick Sudour', 'role': 'CONTACT', 'email': 'promotion.interne@ap-hm.fr', 'phone': '04 91 38 29 03'}], 'overallOfficials': [{'name': 'EMILIE GARRIDO', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique Hopitaux De Marseille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}