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

Primary Purpose

Infertility

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
IN VITRO FERTILIZATION
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infertility

Eligibility Criteria

36 Years - 45 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Assistance des Hôpitaux de MarseilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Exposed

Not exposed

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 11, 2019
Last Updated
April 11, 2019
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT03914859
Brief Title
IMPACT OF POLYCYCLIC AROMATIC HYDROCARBONS (PAH) ON IN VITRO FERTILIZATION
Official Title
HAP-REPRO: IMPACT OF POLYCYCLIC AROMATIC HYDROCARBONS (PAH) ON IN VITRO FECONDATION: PARENTAL CELLS WITH EARLY EMBRYONIC QUALITY.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
February 1, 2021 (Anticipated)
Study Completion Date
February 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Non-Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exposed
Arm Type
Other
Arm Description
Urinary level of 1-hydroxypyrene, the most sensitive biomarker of PAH exposure greater than 0.1 μmol / mol creatinine
Arm Title
Not exposed
Arm Type
Other
Arm Description
Urinary level of 1-hydroxypyrene, the most sensitive marker of PAH exposure below 0.1 μmol / mol creatinine
Intervention Type
Biological
Intervention Name(s)
IN VITRO FERTILIZATION
Intervention Description
Using exposure biomarker as a reliable means of evaluating gamete quality to estimate the chances of success in in vitro fertilization.
Primary Outcome Measure Information:
Title
expired CO
Description
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.
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
36 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeanne PERRIN
Phone
+ 33 (0)491 38 29 00
Email
jeanne.perrin@univ-amu.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Sudour
Phone
04 91 38 29 03
Email
promotion.interne@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EMILIE GARRIDO
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance des Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeanne Perrin
Phone
+ 33 (0)491 38 29 00
Email
jeanne.perrin@univ-amu.fr
First Name & Middle Initial & Last Name & Degree
Patrick Sudour
Phone
04 91 38 29 03
Email
promotion.interne@ap-hm.fr

12. IPD Sharing Statement

Learn more about this trial

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

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