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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-28

Study Completion Date

2023-09-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Exposure to Environmental Pollution

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Sampling on surgery day

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No