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

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Unknown

Conditions: Infertility

Treatments: Biological: IN VITRO FERTILIZATION

Study type: Interventional

Funder types: Other

Identifiers

NCT03914859

2018-32

2018-A00364 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 estimated patients

Sex: All

Ages: 36 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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220 participants in 2 patient groups

Exposed

Other group

Description:

Urinary level of 1-hydroxypyrene, the most sensitive biomarker of PAH exposure greater than 0.1 μmol / mol creatinine

Treatment:

Biological: IN VITRO FERTILIZATION

Not exposed

Other group

Description:

Urinary level of 1-hydroxypyrene, the most sensitive marker of PAH exposure below 0.1 μmol / mol creatinine

Treatment:

Biological: IN VITRO FERTILIZATION