Characterization of Persistent Organic Pollutants Exposure During Preconception and Preimplantation Development. (TUBPOP)

November 14, 2022 updated by: University Hospital, Toulouse

Characterization of Persistent Organic Pollutants Exposure During Preconception and Preimplantation Development in the Human Fallopian Tube: TUBPOP.

In order to evaluate if gametes and preimplantation embryos are in vivo exposed to environmental chemicals, the detection of 6 molecules representative of 3 persistent organic pollutants families will be performed in the mucosa of fallopian tubes obtained after bilateral salpingectomy performed for sterilization purpose in 20 women and compared with concentrations in adipose tissue. This feasibility study is a preliminary step before larger clinical surveys and in vitro studies.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The fallopian tube is the physiological environment of the mature gametes and the preimplantation embryo. While animal and epidemiological data are accumulating that demonstrate the role of alterations of the fetal environment in the programming of post-natal development and health at adulthood, the impact of environmental perturbations during early development (fertilization and preimplantation development) is mainly shown by animal studies (apart persistent questions about health of children conceived after assisted reproductive technologies). Animal expositions to chemical contaminants of the environment targeted on the preimplantation period have been shown to alter health at adulthood. In the same way, in vitro short exposition of male or female gametes to some of these chemicals can impact their functions. It is therefore important to characterize the chemical environment of gametes and preimplantation embryo in the human fallopian tube.

This project aims to demonstrate the feasibility of quantitative measurements for 3 families of persistent environmental contaminants at the oviduct level. In women of reproductive age devoid of any pathology able to alter tubal mucosa, fallopian tubes will be recovered after laparoscopic bilateral salpingectomy performed with the goal of sterilization. Concentrations in the tubal mucosa tissue will be analyzed for at least 2 representative members of 3 chemicals families (organochlorine pesticides (DDE, HCB), polychlorobiphenyls (PCB 153 and 138) and flame retardants (PBDE47 and 153). A comparison with the concentration obtained in the adipose tissue collected at the time of umbilical incision for laparoscopy and in blood will allow to evidence the exposition of each women to each type of contaminant. One bundle of hair strand will be collected from the occipital region of the head and stored for further analysis.

This project is a feasibility study on 20 women but its perspectives are numerous. It is supported by a solid consortium that will assure the recruitment of the women in this indication and its technical implementation.

Study Type

Interventional

Enrollment (Anticipated)

20

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 Contact

Study Contact Backup

Study Locations

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

18 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Addressed to surgery for a voluntary sterilization purpose by bilateral salpingectomy or for total hysterectomy (due to pelvic organs prolapse, functional menorrhagia)
  • No previous pathology affecting directly or indirectly the tubal mucosa
  • Regular menstrual cycles (26 to 34 days) or under estro-progestative contraceptive
  • National health insurance affiliation or equivalent
  • Informed and free consent

Exclusion Criteria:

  • Absence of 1 or 2 fallopian tubes
  • Current or previous disease with persistent effect on tubal mucosa (salpingitis, hydrosalpinx, medically treated extra-uterine pregnancy)
  • BRCA1 or 2 mutation in the subject or her first-degree relatives (parents, siblings, children)
  • ovarian cancer before age of 50 in a first-degree relative
  • uterine, tubal or ovarian anomaly visualized on a presurgical imagery and necessitating a total anatomopathological examination of one of the fallopian tube or a macroscopic anomaly visualized during surgery necessitating a total anatomopathological examination of one of the fallopian tube
  • Contraception using progestative alone
  • Ovarian desensitisation using gonadotropin-releasing hormone (GnRH) agonists
  • Bariatric surgery in the previous year
  • Placement under judicial protection, guardianship, or supervision

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: Test group
Test group is composed of 20 women of reproductive age devoid of any pathology coming to the hospital for a salpingectomy for contraceptive purposes or for a total hysterectomy.
Other: Sampling on surgery day

In the morning, the day of the surgery (the patient will be fasting):

  • Occipital hair sample (without roots)
  • Venous blood sample (3 tubes of 7mL)

During the surgery:

  • Sample of 0.5 to 1 cm3 of subcutaneous adipose tissue during laparoscopic umbilical access
  • Collection of a portion of Ampulla proximal part and Isthmus distal part in order to obtain a piece of approximately 4 cm long (2cm of ampulla and 2 cm of isthmus) for each tube.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects for whom a quantifiable detection for the 6 molecules is obtained
Time Frame: During surgery
A proportion above or equal to 90 % (quantification in 18 women out of 20 at least) will be the threshold retained as a possible quantification.
During surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of intratubal and adipose tissue concentrations of the 6 toxicants
Time Frame: During surgery
For each of the 6 toxicants, a comparison between the observed intratubal and adipose concentrations will be made within the population and a linear or non-linear relationship will be sought.
During surgery

Collaborators and Investigators

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

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Roger LEANDRI, MD, CHU 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)

January 28, 2021

Primary Completion (Anticipated)

July 1, 2024

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

November 6, 2020

First Submitted That Met QC Criteria

November 12, 2020

First Posted (Actual)

November 13, 2020

Study Record Updates

Last Update Posted (Actual)

November 15, 2022

Last Update Submitted That Met QC Criteria

November 14, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RC31/19/0257 (Other Grant/Funding Number: Biomedicine Agency)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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