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Trial record 3 of 12 for:    Endocrine Disruptors

AROPE : Early Ovarian Reserve Decreased : Impact of Exposure to Persistent Endocrine Disruptors and Organic Solvents (AROPE)

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ClinicalTrials.gov Identifier: NCT02802397
Recruitment Status : Recruiting
First Posted : June 16, 2016
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Female Infertility Other: Self-administered questionnaire and blood and urine samples Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 504 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: AROPE : Early Ovarian Reserve Decreased : Impact of Exposure to Persistent Endocrine Disruptors and Organic Solvents
Study Start Date : December 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Other: Self-administered questionnaire and blood and urine samples
Self-administered questionnaire and blood and urine samples

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.

Other: Self-administered questionnaire and blood and urine samples
Self-administered questionnaire and blood and urine samples




Primary Outcome Measures :
  1. Persistant organic pollutants dosage [ Time Frame: Day 1 ]
    Persistant organic pollutants levels


Secondary Outcome Measures :
  1. Organic solvents dosage [ Time Frame: Day 1 ]
    Occupational exposure to organic solvents

  2. Glycol ethers métabolites dosage [ Time Frame: Day 1 ]
    Occupational exposure to glycol ethers metabolites.

  3. Heavy metals dosage [ Time Frame: Day 1 ]
    Occupational exposure to heavy metals.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria :

For cases :

  • Women among news couples seeking to conceive (12 months tentative) and consulting among 4 fertility centers in Western France : Brest University hospital, Rennes University hospital, La Sagesse mutuality hospital, Nantes University hospital,
  • With at least one ovarian reserve decreased characteristic : Follicle antral counts (left and right ovaries) below 7 and/or anti-mullerian hormon (AMH) equal or below 1.1 ng/ml,
  • Age between 18 and 40 years,
  • Signed informed consent.

For each cases, two controls will be included matched on center and on age classes (5years). Controls will be :

  • Women among news couples seeking to conceive (12 months tentative) and consulting among 4 fertility centers in Western France : Brest University hospital, Rennes University hospital, La Sagesse mutuality hospital, Nantes University hospital,
  • With infertility examination considered as normal (AMH between 2 and 5 ng/ml, without genital malformations and with a menstrual cycle comprise between 27 and 32 days) and partner with an identified infertility etiology (migration test below 1 million spermatozoids progressive mobility),
  • Age between 18 and 40 years,
  • Signed informed consent.

Exclusion Criteria (cases and controls) :

  • Ovarian endometriosis,
  • SPOK,
  • annedal surgery antecedent,
  • cancer with chemiotherapy and radiotherapy antecedent,
  • Body mass index ≥ 35 kg/m²,
  • Women with legal protection measures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02802397


Contacts
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Contact: Ronan Garlantezec, MD 0033299289300 ronan.garlantezec@chu-rennes.fr

Locations
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France
Brest university hospital Recruiting
Brest, France, 29609
Contact: Marie-Thérèse Le Martelot, MD    0033298223222    marie-therese@lemartelot@chu-brest.fr   
Principal Investigator: Marie-Thérèse Le Martelot, MD         
Nantes university hospital Recruiting
Nantes, France, 44093
Contact: Paul Barrière, MD    0033240083397    paul.barriere@chu-nantes.fr   
Principal Investigator: Paul Barrière, MD         
Cabinet de Gynécologie Malakoff Recruiting
Rennes, France, 35000
Contact: Anne Guivarc'h, MD    0033223448370    anne.guivarch@orange.fr   
Principal Investigator: Anne Guivarc'h, MD         
Clinique Mutualiste de La Sagesse Recruiting
Rennes, France, 35000
Contact: Anne Guivarc'h, MD    0033223448370    anne.guivarch@orange.fr   
Principal Investigator: Anne Guivarc'h, MD         
Rennes university hospital Recruiting
Rennes, France, 35200
Contact: Solène Duros, MD    0033299284321 ext 63179    solene.duros@chu-rennes.fr   
Principal Investigator: Solène Duros, MD         
Sponsors and Collaborators
Rennes University Hospital

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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT02802397     History of Changes
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 )
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019

Keywords provided by Rennes University Hospital:
Early ovarian reserve decreased

Additional relevant MeSH terms:
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Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female
Endocrine Disruptors
Physiological Effects of Drugs