- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT03914859
IMPACT OF POLYCYCLIC AROMATIC HYDROCARBONS (PAH) ON IN VITRO FERTILIZATION
HAP-REPRO: IMPACT OF POLYCYCLIC AROMATIC HYDROCARBONS (PAH) ON IN VITRO FECONDATION: PARENTAL CELLS WITH EARLY EMBRYONIC QUALITY.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
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.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Marseille, Frankrijk, 13354
- Werving
- Assistance des Hôpitaux de Marseille
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Contact:
- Patrick Sudour
- Telefoonnummer: 04 91 38 29 03
- E-mail: promotion.interne@ap-hm.fr
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Contact:
- Jeanne Perrin
- Telefoonnummer: + 33 (0)491 38 29 00
- E-mail: jeanne.perrin@univ-amu.fr
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Couples whose wife is under 36 and the man under 45 at the time of IVF
- 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:
- Refusal to participate in the study of one or both members of the couple
- 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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Ander: Exposed
Urinary level of 1-hydroxypyrene, the most sensitive biomarker of PAH exposure greater than 0.1 μmol / mol creatinine
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Using exposure biomarker as a reliable means of evaluating gamete quality to estimate the chances of success in in vitro fertilization.
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Ander: Not exposed
Urinary level of 1-hydroxypyrene, the most sensitive marker of PAH exposure below 0.1 μmol / mol creatinine
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Using exposure biomarker as a reliable means of evaluating gamete quality to estimate the chances of success in in vitro fertilization.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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expired CO
Tijdsspanne: 72 hours
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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. On 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. |
72 hours
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2018-32
- 2018-A00364 (Register-ID: APHM)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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