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.
2 other identifiers
interventional
220
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2019
CompletedFirst Submitted
Initial submission to the registry
April 11, 2019
CompletedFirst Posted
Study publicly available on registry
April 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2022
CompletedApril 16, 2019
April 1, 2019
2 years
April 11, 2019
April 11, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Exposed
OTHERUrinary level of 1-hydroxypyrene, the most sensitive biomarker of PAH exposure greater than 0.1 μmol / mol creatinine
Not exposed
OTHERUrinary level of 1-hydroxypyrene, the most sensitive marker of PAH exposure below 0.1 μmol / mol creatinine
Interventions
Using exposure biomarker as a reliable means of evaluating gamete quality to estimate the chances of success in in vitro fertilization.
Eligibility Criteria
You may qualify if:
- 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)
- st 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assistance des Hôpitaux de Marseille
Marseille, 13354, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
EMILIE GARRIDO
Assistance Publique Hopitaux De Marseille
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2019
First Posted
April 16, 2019
Study Start
February 1, 2019
Primary Completion
February 1, 2021
Study Completion
February 1, 2022
Last Updated
April 16, 2019
Record last verified: 2019-04