InfertilityNCT03914859
IMPACT OF POLYCYCLIC AROMATIC HYDROCARBONS (PAH) ON IN VITRO FERTILIZATION
A study testing IN VITRO FERTILIZATION in people with Infertility, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 36 to 45 years
- Conditions the study is for
- Infertility
- What is being tested?
- IN VITRO FERTILIZATION
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2019to 1 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance des Hôpitaux de Marseille
Marseille, 13354
Jeanne Perrin, + 33 (0)491 38 29 00, jeanne.perrin@univ-amu.fr
Patrick Sudour, 04 91 38 29 03, promotion.interne@ap-hm.fr
About this study
Official title: HAP-REPRO: IMPACT OF POLYCYCLIC AROMATIC HYDROCARBONS (PAH) ON IN VITRO FECONDATION: PARENTAL CELLS WITH EARLY EMBRYONIC QUALITY.
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.
Read the 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.
- Conditions
- Infertility
- Being tested
- IN VITRO FERTILIZATION
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IN VITRO FERTILIZATIONBiological
Using exposure biomarker as a reliable means of evaluating gamete quality to estimate the chances of success in in vitro fertilization.
| Study group | Role | What they receive |
|---|---|---|
| Exposed | Other | Urinary level of 1-hydroxypyrene, the most sensitive biomarker of PAH exposure greater than 0.1 μmol / mol creatinine Receives: 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 Receives: Biological: IN VITRO FERTILIZATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start1 Feb 2019
- Primary completion1 Feb 2021 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EMILIE GARRIDO, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914859
- Sponsor's protocol ID
- 2018-32
- Other IDs
- 2018-A00364
- Status last verified
- Apr 2019
- First submitted
- 11 Apr 2019
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HAP-REPRO: IMPACT OF POLYCYCLIC AROMATIC HYDROCARBONS (PAH) ON IN VITRO FECONDATION: PARENTAL CELLS WITH EARLY EMBRYONIC QUALITY.
- ClinicalTrials.gov ID
- NCT03914859
- Acronym / sponsor ID
- 2018-32
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Exposed | Other | Biological: IN VITRO FERTILIZATIONUrinary level of 1-hydroxypyrene, the most sensitive biomarker of PAH exposure greater than 0.1 μmol / mol creatinine |
| Not exposed | Other | Biological: IN VITRO FERTILIZATIONUrinary level of 1-hydroxypyrene, the most sensitive marker of PAH exposure below 0.1 μmol / mol creatinine |
Who may qualify
- Ages
- 36 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IN VITRO FERTILIZATIONUsing exposure biomarker as a reliable means of evaluating gamete quality to estimate the chances of success in in vitro fertilization. | Biological | Exposed, Not exposed |
Primary outcome
expired CO
Time frame: 72 hours
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
EMILIE GARRIDO study director
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IN VITRO FERTILIZATION in people with Infertility, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeanne PERRIN (+ 33 (0)491 38 29 00, jeanne.perrin@univ-amu.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
expired CO (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.