NCT02802397

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
335

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

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

First Submitted

Initial submission to the registry

May 17, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 16, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

December 6, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2020

Completed
Last Updated

May 23, 2023

Status Verified

May 1, 2023

Enrollment Period

3.2 years

First QC Date

May 17, 2016

Last Update Submit

May 22, 2023

Conditions

Female Infertility

Keywords

Early ovarian reserve decreased

Outcome Measures

Primary Outcomes (1)

  • Persistant organic pollutants dosage

    Persistant organic pollutants levels

    Day 1

Secondary Outcomes (3)

  • Organic solvents dosage

    Day 1

  • Glycol ethers métabolites dosage

    Day 1

  • Heavy metals dosage

    Day 1

Study Arms (2)

Cases

OTHER

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

Controls

OTHER

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

Interventions

Self-administered questionnaire and blood and urine samplesOTHER

Self-administered questionnaire and blood and urine samples

CasesControls

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.
  • ovarian endometriosis,
  • polycystic ovary syndrome,
  • a history of adnexal surgery,
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Brest university hospital

Brest, 29609, France

Location

Nantes university hospital

Nantes, 44093, France

Location

Cabinet de Gynécologie Malakoff

Rennes, 35000, France

Location

Clinique Mutualiste de La Sagesse

Rennes, 35000, France

Location

Rennes university hospital

Rennes, 35200, France

Location

Related Publications (1)

  • Genard-Walton M, Warembourg C, Duros S, Mercier F, Lefebvre T, Guivarc'h-Leveque A, Le Martelot MT, Le Bot B, Jacquemin B, Chevrier C, Cordier S, Costet N, Multigner L, Garlantezec R. Serum persistent organic pollutants and diminished ovarian reserve: a single-exposure and mixture exposure approach from a French case-control study. Hum Reprod. 2023 Apr 3;38(4):701-715. doi: 10.1093/humrep/dead028.

    PMID: 36881900RESULT

MeSH Terms

Conditions

Infertility, Female

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2016

First Posted

June 16, 2016

Study Start

December 6, 2016

Primary Completion

February 6, 2020

Study Completion

November 2, 2020

Last Updated

May 23, 2023

Record last verified: 2023-05

Locations

FR(5)