Bisphenol A Exposure, Ovarian Function and Assisted Reproductive Technology Outcome. (FIVPHENOL)

July 11, 2019 updated by: University Hospital, Toulouse
Our goal is to prospect the relationships between Bisphenol A (BPA) exposure (measured as its free and conjugated forms in blood and urine) and embryo implantation rate (measured as the ratio between the number of gestational sacs and the number of transferred embryos) after assisted reproductive technology. In order to reduce the confusion factors, the population study is limited to young women (aged 28 to 34), with regular menstrual cycles and without any medical event that could affect the implantation process

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Among the various suspected adverse effects of BPA on human health, studies on the possible effects of BPA on reproduction are limited. Animal and in vitro studies indicate that BPA exposure can lead to disrupted oocyte maturation, E2 suppression and early pregnancy loss caused by chromosomal abnormalities. In the woman, studies about the consequences of BPA exposure on reproduction is a very difficult task since gametogenesis in the woman spreads over decades, from the intra-uterine life where meiosis is initiated to the end of the reproductive period at menopause. Recently, a decreased survival of human foetal oocytes cultured in vitro in the presence of BPA has been shown suggesting that in vivo exposure in foetal life could affect the ovarian reserve. Furthermore, a negative association between urinary BPA level and serum peak E2, oocyte yield and blastocyst formation has been suggested on a limited population of women performing ART. These results suggest that, in adulthood, both quantity and quality of human oocytes could be affected by BPA exposures. The study aims to respond to these questions by evaluating the relationships between BPA exposition levels and embryo implantation rates (as a marker of oocyte quality) and anti-Mullerian hormon (AMH) levels (as a marker of ovarian reserve) in large population of young adult women performing ART. BPA exposure will be assessed at two times in both blood and urine: 1°) before the ovarian stimulation at the time of ovarian reserve tests and 2°) at the end of the ovarian stimulation the day of the ovarian puncture for IVF.

Study Type

Interventional

Enrollment (Actual)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • University Hospital
      • Brest, France
        • CHRU Brest Hôpital Morvan, Service de Médecine de la Reproduction
      • Dijon, France, 21000
        • University Hospital
      • Lille, France, 59037
        • University Hospital
      • Limoges, France
        • CHU Limoges, Centre d'AMP
      • Nantes, France, 44093
        • University Hospital
      • Poissy, France, 78303
        • Hospital
      • Toulouse, France, 31052
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 34 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Couples attending an IVF or ICSI attempt whose woman is aged 28 ans to 34 at inclusion time
  • Regular menstrual cycles (between 27 and 33 days)
  • 1st or 2nd IVF or ICSI attempt with an embryo transfer at D2 or D3

Exclusion Criteria:

  • couple already included in the study
  • ovarian surgery history
  • uterine (malformation, diethylstilbestrol (DES) syndrome, adenomyosis…) or systemic pathology that can affect implantation (thrombophilia, antiphospholipids syndrome…)
  • chemotherapy history for the woman
  • any endocrinopathy (except dysthyroid) in the woman
  • any pelvic surgery for the woman in the 3 months preceding inclusion
  • endometriosis
  • ICSI with testicular sperm
  • Positive viral load for HIV, hepatitis C virus or hepatitis B virus (HCV or HBV) during the year preceding inclusion in one or both members of the couple

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: couples
couples attending an IVF or intra cytoplasmic sperm injection (ICSI) attempt have hormonal and blood analysis
Other: hormonal and blood analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
embryo implantation rate
Time Frame: 6 weeks after implantation
an ultrasonography between the 5th and 7th week after embryo transfer
6 weeks after implantation

Secondary Outcome Measures

Outcome Measure
Time Frame
serum AMH
Time Frame: 4 days after inclusion
4 days after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Roger Léandri, MD, University Hospital, Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

December 17, 2013

First Submitted That Met QC Criteria

February 25, 2015

First Posted (Estimate)

March 3, 2015

Study Record Updates

Last Update Posted (Actual)

July 15, 2019

Last Update Submitted That Met QC Criteria

July 11, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • RC31/12/0571
  • PHRC 2012 (Other Grant/Funding Number: PHRC)

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.

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