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.

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.

Study Overview

• Status: Unknown
• Conditions: Infertility
• Intervention / Treatment: Biological: IN VITRO FERTILIZATION

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.

• Study Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13354
    • Recruiting
    • Assistance des Hôpitaux de Marseille
    • Contact: Patrick Sudour; Phone Number: 04 91 38 29 03; Email: promotion.interne@ap-hm.fr
    • Contact: Jeanne Perrin; Phone Number: + 33 (0)491 38 29 00; Email: jeanne.perrin@univ-amu.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
expired CO	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

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: April 11, 2019
• First Submitted That Met QC Criteria: April 11, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 11, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 2018-32; 2018-A00364 (Registry Identifier: APHM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No