IMPACT OF POLYCYCLIC AROMATIC HYDROCARBONS (PAH) ON IN VI... | NCT03914859

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

NCT03914859

Sponsor

Assistance Publique Hopitaux De Marseille

Status

Unknown status

Last Update Posted

Apr 16, 2019Actual

Enrollment

220Estimated

Phase

Not Applicable

Conditions

Infertility

Interventions

IN VITRO FERTILIZATION

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2018-A00364	Registry Identifier	APHM

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2019Actual

Primary Completion Date

Feb 1, 2021Estimated

Completion Date

Feb 1, 2022Estimated

First Submitted Date

Apr 11, 2019

First Submission Date that Met QC Criteria

Apr 11, 2019

First Posted Date

Apr 16, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2019

Last Update Posted Date

Apr 16, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

220Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exposed	Other	Urinary level of 1-hydroxypyrene, the most sensitive biomarker of PAH exposure greater than 0.1 μmol / mol creatinine	Biological: IN VITRO FERTILIZATION
Not exposed	Other	Urinary level of 1-hydroxypyrene, the most sensitive marker of PAH exposure below 0.1 μmol / mol creatinine	Biological: IN VITRO FERTILIZATION

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IN VITRO FERTILIZATION	Biological	Using exposure biomarker as a reliable means of evaluating gamete quality to estimate the chances of success in in vitro fertilization.	Exposed

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

36 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

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

Overall Officials

Name	Affiliation	Role
EMILIE GARRIDO	Assistance Publique Hopitaux De Marseille	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assistance des Hôpitaux de Marseille	Recruiting	Marseille		13354	France

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005307	Fertilization in Vitro

Ancestor Terms

ID	Term
D027724	Reproductive Techniques, Assisted
D012099	Reproductive Techniques
D013812	Therapeutics
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided

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.