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IMPACT OF POLYCYCLIC AROMATIC HYDROCARBONS (PAH) ON IN VITRO FERTILIZATION

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ClinicalTrials.gov Identifier: NCT03914859
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Infertility Biological: IN VITRO FERTILIZATION Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

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.

Masking: Single (Participant)
Primary Purpose: Other
Official Title: HAP-REPRO: IMPACT OF POLYCYCLIC AROMATIC HYDROCARBONS (PAH) ON IN VITRO FECONDATION: PARENTAL CELLS WITH EARLY EMBRYONIC QUALITY.
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 1, 2022

Arm Intervention/treatment
Exposed
Urinary level of 1-hydroxypyrene, the most sensitive biomarker of PAH exposure greater than 0.1 μmol / mol creatinine
Biological: 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
Biological: IN VITRO FERTILIZATION
Using exposure biomarker as a reliable means of evaluating gamete quality to estimate the chances of success in in vitro fertilization.




Primary Outcome Measures :
  1. expired CO [ Time Frame: 72 hours ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   36 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03914859


Contacts
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Contact: Jeanne PERRIN + 33 (0)491 38 29 00 jeanne.perrin@univ-amu.fr
Contact: Patrick Sudour 04 91 38 29 03 promotion.interne@ap-hm.fr

Locations
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France
Assistance des Hôpitaux de Marseille Recruiting
Marseille, France, 13354
Contact: Jeanne Perrin    + 33 (0)491 38 29 00    jeanne.perrin@univ-amu.fr   
Contact: Patrick Sudour    04 91 38 29 03    promotion.interne@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: EMILIE GARRIDO Assistance Publique Hopitaux De Marseille
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03914859    
Other Study ID Numbers: 2018-32
2018-A00364 ( Registry Identifier: APHM )
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility