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

NCT04628091 | Completed

• 1 other identifier: RC31/19/0257
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Exposure to Environmental Pollution

Keywords

Chemical exposome; Fallopian tube; Persistent Organic Pollutants

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects for whom a quantifiable detection for the 6 molecules is obtained

  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 Outcomes (1)

• Comparison of intratubal and adipose tissue concentrations of the 6 toxicants

  During surgery

Study Arms (1)

Test group

EXPERIMENTAL

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

Interventions

Sampling on surgery day OTHER

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.

Test group

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU Toulouse

Toulouse, 31059, France

Location

Related Publications (5)

• Rappaport SM. Genetic Factors Are Not the Major Causes of Chronic Diseases. PLoS One. 2016 Apr 22;11(4):e0154387. doi: 10.1371/journal.pone.0154387. eCollection 2016.

  PMID: 27105432 BACKGROUND

• Lee DH, Jacobs DR Jr, Porta M. Hypothesis: a unifying mechanism for nutrition and chemicals as lifelong modulators of DNA hypomethylation. Environ Health Perspect. 2009 Dec;117(12):1799-802. doi: 10.1289/ehp.0900741. Epub 2009 Jul 8.

  PMID: 20049195 BACKGROUND

• Dereumeaux C, Saoudi A, Pecheux M, Berat B, de Crouy-Chanel P, Zaros C, Brunel S, Delamaire C, le Tertre A, Lefranc A, Vandentorren S, Guldner L. Biomarkers of exposure to environmental contaminants in French pregnant women from the Elfe cohort in 2011. Environ Int. 2016 Dec;97:56-67. doi: 10.1016/j.envint.2016.10.013. Epub 2016 Oct 24.

  PMID: 27788374 BACKGROUND

• Lee WC, Fisher M, Davis K, Arbuckle TE, Sinha SK. Identification of chemical mixtures to which Canadian pregnant women are exposed: The MIREC Study. Environ Int. 2017 Feb;99:321-330. doi: 10.1016/j.envint.2016.12.015. Epub 2016 Dec 29.

  PMID: 28040263 BACKGROUND

• Watkins AJ, Fleming TP. Blastocyst environment and its influence on offspring cardiovascular health: the heart of the matter. J Anat. 2009 Jul;215(1):52-9. doi: 10.1111/j.1469-7580.2008.01033.x. Epub 2009 Feb 9.

  PMID: 19215321 BACKGROUND

Study Officials

• Roger LEANDRI, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 13, 2020
• Study Start: January 28, 2021
• Primary Completion: September 18, 2023
• Study Completion: September 18, 2023
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)