Characterization of Persistent Organic Pollutants Exposure During Preconception and Preimplantati… (NCT04628091) | Clinical Trial Compass
CompletedNot Applicable
Characterization of Persistent Organic Pollutants Exposure During Preconception and Preimplantation Development.
France20 participantsStarted 2021-01-28
Plain-language 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.
Who can participate
Age range
18 Years – 43 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of subjects for whom a quantifiable detection for the 6 molecules is obtained