IMPACT OF POLYCYCLIC AROMATIC HYDROCARBONS (PAH) ON IN VITRO FERTILIZATION
NCT ID: NCT03914859
Last Updated: 2019-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
220 participants
INTERVENTIONAL
2019-02-01
2022-02-01
Brief Summary
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Detailed Description
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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.
Subsequently, 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.
To highlight a relationship between individual exposures to complex PAH mixtures and infertility.
The 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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
It 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.
OTHER
SINGLE
Study Groups
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Exposed
Urinary level of 1-hydroxypyrene, the most sensitive biomarker of PAH exposure greater than 0.1 μmol / mol creatinine
IN VITRO FERTILIZATION
Using exposure biomarker as a reliable means of evaluating gamete quality to estimate the chances of success in in vitro fertilization.
Not exposed
Urinary level of 1-hydroxypyrene, the most sensitive marker of PAH exposure below 0.1 μmol / mol creatinine
IN VITRO FERTILIZATION
Using exposure biomarker as a reliable means of evaluating gamete quality to estimate the chances of success in in vitro fertilization.
Interventions
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IN VITRO FERTILIZATION
Using exposure biomarker as a reliable means of evaluating gamete quality to estimate the chances of success in in vitro fertilization.
Eligibility Criteria
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Inclusion Criteria
* Regular cycles of 27 to 33 days in women
* Management of classical IVF (without the use of micro-sperm injection)
* 1st or 2nd attempt of IVF
* Signature of informed consent by both partners of the couple
* Affiliation to a social security scheme or equivalent for both partners of the couple.
Exclusion Criteria
* No fluency in French
* History likely to alter the ovarian reserve, endometriosis
* Uterine or systemic antecedents, likely to affect implantation
* Andrological antecedents likely to alter fertilization rates
* History of chemotherapy / radiotherapy
* Positive plasma viral load for HIV, HCV or HBV in the year prior to inclusion in one of the members of the couple
36 Years
45 Years
ALL
No
Sponsors
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Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
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Principal Investigators
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EMILIE GARRIDO
Role: STUDY_DIRECTOR
Assistance Publique Hopitaux De Marseille
Locations
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Assistance des Hôpitaux de Marseille
Marseille, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2018-A00364
Identifier Type: REGISTRY
Identifier Source: secondary_id
2018-32
Identifier Type: -
Identifier Source: org_study_id
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