- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02802397
AROPE : Early Ovarian Reserve Decreased : Impact of Exposure to Persistent Endocrine Disruptors and Organic Solvents (AROPE)
Early ovarian reserve decreased is one of the main causes of infertility for women after 35 years. The relationship between this decreased and exposure to chemicals, including persistent endocrine disruptors or organic solvents, has been little studied. However, several in vivo or in vitro experimental studies suggested that these chemicals may impaired ovarian function.
The main objective is to study the relationship between early ovarian reserve decreased and exposure to persistent organic pollutants.
The secondary objectives are to study the relationship between early ovarian reserve decreased and exposure to organic solvents and heavy metals.
Multicenter case-control study. This project will permit to increase the knowledge concerning the etiology of early decreased ovarian reserve. Considering that exposure of interest are frequent, the results may be important in a public health perspective. If associations are observed in this study, the results may encouraged prevention strategy.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cases and controls will benefit, as usual in France concerning infertility etiology examinations, of a follicle antral count by transvaginal ultrasound and AMH measurement.
At baseline, physicians will complete a short questionnaire to check the inclusion criterion, the results of the measurement of follicle count and hormone measurement (including AMH). Cases and controls will respond to self-administered questionnaire at inclusion with information about their medical history, their demographics, their tobacco and alcohol consumption, their occupation and products handled in the workplace. Blood samples (for measure of persistent organic pollutants and heavy metals) and urine (for measure of metabolites of glycol ethers) will be collect at baseline. Occupational exposures to solvents will be defined using job exposures matrices. The risk of decreased ovarian reserve will be analyzed using logistic regressions for each exposure of interest adjusting for potential confounders.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Brest, France, 29609
- Brest University Hospital
-
Nantes, France, 44093
- Nantes university hospital
-
Rennes, France, 35000
- Cabinet de Gynécologie Malakoff
-
Rennes, France, 35000
- Clinique Mutualiste de La Sagesse
-
Rennes, France, 35200
- Rennes University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria :
The cases will be:
- women among couples consulting for infertility in 4 centers for medically assisted procreation (AMP) performing in vitro fertilization in the Brittany Pays de Loire region: the university hospital (CHU) of BREST, the CHU of RENNES, the La Sagesse clinic in RENNES and the CHU de NANTES,
- having at least one characteristic of alteration of the ovarian reserve: a total number of antral follicles (left ovary + right ovary) less than 7 and / or a blood level of anti-Müllerian hormone (AMH) less than or equal to 1 , 1 ng / ml,
- age between 18 and 40 years old,
- with, in the event of past stimulation, at least one month since the last stimulation at the time of the blood and urine samples,
- having signed a free and informed consent.
For each case, two controls will be included with a pairing on the center and on the age group of 5 years (frequency pairing). It will be :
- women among couples consulting for infertility in 4 centers for medically assisted procreation (AMP) performing in vitro fertilization in the Brittany Pays de Loire region: the university hospital (CHU) of BREST, the CHU of RENNES, the La Sagesse clinic in RENNES and the CHU de NANTES,
- whose infertility assessment is strictly normal (AMH between 1.5 and 5 ng / ml, without genital malformation and with a menstrual cycle between 26 and 35 days),
- age between 18 and 40 years old,
- with, in the event of past stimulation, at least one month since the last stimulation at the time of the blood and urine samples,
- having signed a free and informed consent.
The non-inclusion criteria for cases and witnesses will be:
- ovarian endometriosis,
- polycystic ovary syndrome,
- a history of adnexal surgery,
- a history of cancer with chemotherapy or radiotherapy,
- morbid obesity (BMI ≥ 35 kg / m²),
- a chromosomal genetic syndrome (Turner and Fragile X)
- adults who are the subject of legal protection (safeguard of justice, curatorship, guardianship) and persons deprived of their liberty.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Cases
Cases and controls will benefit, as usual in France concerning infertility etiology examinations, of a follicle antral count by transvaginal ultrasound and AMH measurement. At baseline, physicians will complete a short questionnaire to check the inclusion criterion, the results of the measurement of follicle count and hormone measurement (including AMH). Cases and controls will respond to self-administered questionnaire at inclusion with information about their medical history, their demographics, their tobacco and alcohol consumption, their occupation and products handled in the workplace. Blood samples (for measure of persistent organic pollutants and heavy metals) and urine (for measure of metabolites of glycol ethers) will be collect at baseline. Occupational exposures to solvents will be defined using job exposures matrices. The risk of decreased ovarian reserve will be analyzed using logistic regressions for each exposure of interest adjusting for potential confounders. |
Self-administered questionnaire and blood and urine samples
|
Other: Controls
Cases and controls will benefit, as usual in France concerning infertility etiology examinations, of a follicle antral count by transvaginal ultrasound and AMH measurement. At baseline, physicians will complete a short questionnaire to check the inclusion criterion, the results of the measurement of follicle count and hormone measurement (including AMH). Cases and controls will respond to self-administered questionnaire at inclusion with information about their medical history, their demographics, their tobacco and alcohol consumption, their occupation and products handled in the workplace. Blood samples (for measure of persistent organic pollutants and heavy metals) and urine (for measure of metabolites of glycol ethers) will be collect at baseline. Occupational exposures to solvents will be defined using job exposures matrices. The risk of decreased ovarian reserve will be analyzed using logistic regressions for each exposure of interest adjusting for potential confounders. |
Self-administered questionnaire and blood and urine samples
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Persistant organic pollutants dosage
Time Frame: Day 1
|
Persistant organic pollutants levels
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Organic solvents dosage
Time Frame: Day 1
|
Occupational exposure to organic solvents
|
Day 1
|
Glycol ethers métabolites dosage
Time Frame: Day 1
|
Occupational exposure to glycol ethers metabolites.
|
Day 1
|
Heavy metals dosage
Time Frame: Day 1
|
Occupational exposure to heavy metals.
|
Day 1
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 35RC16_9748_AROPE
- 2016-A00307-44 (Registry Identifier: ANSM)
- 16/14-1012 (Other Identifier: CPP Ouest V (Rennes))
- 160295B-22 (Other Identifier: ANSM)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Female Infertility
-
Esraa Gamal AhmedAin Shams Maternity HospitalUnknownUnexplained Female Infertility
-
Pacific Fertility CenterTerminatedPrimary Female Infertility | Secondary Female Infertility
-
Assuta Hospital SystemsMaccabi Healthcare Services, IsraelCompletedInfertility, Female Infertility, Male InfertilityIsrael
-
Newlife Fertility CentreRecruitingInfertility | Infertility,Female | Infertility Unexplained | Infertility of Uterine Origin | Infertility; Female, NonimplantationCanada
-
Cairo UniversityCompleted
-
Navy General Hospital, BeijingUnknownFemale Infertility Due to Nonimplantation of OvumChina
-
Wake Forest University Health SciencesWithdrawnUterine Diseases | Endometriosis | Infertility Unexplained | Endometrial Diseases | Infertility; Female, NonimplantationUnited States
-
Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and DevelopmentCompletedPregnancy | Male Infertility | Female InfertilityNetherlands
-
Sapientiae InstituteTerminated
-
Woman's Health University Hospital, EgyptCompletedFemale Infertility Due to Diminished Ovarian ReserveEgypt
Clinical Trials on Self-administered questionnaire and blood and urine samples
-
University of CambridgeCompleted
-
Memorial Sloan Kettering Cancer CenterYale University; University of New MexicoCompleted
-
International Vaccine InstituteLondon School of Hygiene and Tropical Medicine; Karolinska Institutet; Centers...Not yet recruitingHPV InfectionZambia, Bangladesh, Congo, The Democratic Republic of the, Ghana, Nepal, Pakistan, Sierra Leone, Tanzania
-
Hospices Civils de LyonUnknownWilliams-Beuren Syndrome | Micro-duplication 7q11.23 Syndrome | VasculopathyFrance
-
Assistance Publique - Hôpitaux de ParisCompletedCongenital Heart Defects | Chronic Kidney FailureFrance
-
Centre Hospitalier Universitaire, AmiensInstitut Pasteur de Lille; Université de LilleRecruitingNephrolithiasis | Kidney StoneFrance
-
University Hospital, LimogesUniversity Hospital Federation FHU SUPORTRecruiting
-
Herlev HospitalCompletedChronic Kidney Diseases | Mineral Metabolism DisorderDenmark
-
Assistance Publique Hopitaux De MarseilleCompleted
-
University Hospital, MontpellierBeziers HospitalNot yet recruiting