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

NCT ID: NCT03914859

Last Updated: 2019-04-16

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2022-02-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Infertility

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

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

Group Type OTHER

IN VITRO FERTILIZATION

Intervention Type BIOLOGICAL

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

Group Type OTHER

IN VITRO FERTILIZATION

Intervention Type BIOLOGICAL

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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

36 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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France

Central Contacts

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Jeanne PERRIN

Role: CONTACT

+ 33 (0)491 38 29 00

Patrick Sudour

Role: CONTACT

04 91 38 29 03

Facility Contacts

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Jeanne Perrin

Role: primary

+ 33 (0)491 38 29 00

Patrick Sudour

Role: backup

04 91 38 29 03

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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