Clinical trial NCT04628091: Characterization of Persistent Organic Pollutants Exposure During Preconception and Preimplantation Development.
Official title: Characterization of Persistent Organic Pollutants Exposure During Preconception and Preimplantation Development in the Human Fallopian Tube: TUBPOP.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exposure to Environmental Pollution
Keywords: Chemical exposome
Fallopian tube
Persistent Organic Pollutants
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of subjects for whom a quantifiable detection for the 6 molecules is obtained
timeFrame: During surgery
Secondary outcomes:
measure: Comparison of intratubal and adipose tissue concentrations of the 6 toxicants
timeFrame: During surgery
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: CHU Toulouse
name: Roger LEANDRI, MD
role: PRINCIPAL_INVESTIGATOR
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