Exposure to Environmental PollutionTUBPOPNCT04628091
Characterization of Persistent Organic Pollutants Exposure During Preconception and Preimplantation Development.
A study testing Sampling on surgery day in people with Exposure to Environmental Pollution, run by University Hospital, Toulouse at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Exposure to Environmental Pollution
- What is being tested?
- Sampling on surgery day
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jan 2021to 18 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- Ovarian desensitisation using gonadotropin-releasing hormone (GnRH) agonists
- Bariatric surgery in the previous year
- Placement under judicial protection, guardianship, or supervision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Exposure to Environmental Pollution
- Being tested
- Sampling on surgery day
- Keywords
- Chemical exposome, Fallopian tube, Persistent Organic Pollutants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sampling on surgery dayOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Sampling on surgery day |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During surgery
Secondary outcomes (1)
Comparison of intratubal and adipose tissue concentrations of the 6 toxicants
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.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start28 Jan 2021
- Primary completion18 Sep 2023
- Study completion18 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Exposure to Environmental PollutionStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roger LEANDRI, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04628091
- Sponsor's protocol ID
- RC31/19/0257
- Other IDs
- RC31/19/0257
- Acronym
- TUBPOP
- Status last verified
- Jul 2024
- First submitted
- 6 Nov 2020
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27105432Lee 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.
PubMed 20049195Dereumeaux 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.
PubMed 27788374Lee 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.
PubMed 28040263Watkins 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.
PubMed 19215321
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Persistent Organic Pollutants Exposure During Preconception and Preimplantation Development in the Human Fallopian Tube: TUBPOP.
- ClinicalTrials.gov ID
- NCT04628091
- Acronym / sponsor ID
- TUBPOP / RC31/19/0257
- Conditions
- Exposure to Environmental Pollution
- Keywords
- Chemical exposome, Fallopian tube, Persistent Organic Pollutants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 18 Sep 2023 (actual)
- Study completion
- 18 Sep 2023 (actual)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Other: Sampling on surgery dayTest 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. |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sampling on surgery dayIn 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. | Other | Test group |
Primary outcome
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.
1 secondary outcome
Comparison of intratubal and adipose tissue concentrations of the 6 toxicants
Time frame: During surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Background: PubMed 27105432Rappaport 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.
- Background: PubMed 20049195Lee 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.
- Background: PubMed 27788374Dereumeaux 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.
- Background: PubMed 28040263Lee 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.
- Background: PubMed 19215321Watkins 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger LEANDRI, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sampling on surgery day in people with Exposure to Environmental Pollution, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects for whom a quantifiable detection for the 6 molecules is obtained (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04628091, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.