Trials / Completed
CompletedNCT04628091
Characterization of Persistent Organic Pollutants Exposure During Preconception and Preimplantation Development.
Characterization of Persistent Organic Pollutants Exposure During Preconception and Preimplantation Development in the Human Fallopian Tube: TUBPOP.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- University Hospital, Toulouse · Academic / Other
- Sex
- Female
- Age
- 18 Years – 43 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-01-28
- Primary completion
- 2023-09-18
- Completion
- 2023-09-18
- First posted
- 2020-11-13
- Last updated
- 2024-07-19
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04628091. Inclusion in this directory is not an endorsement.