Female Fertility, Environmental Agents and Stress Oxidant
Condition(s) studied
Investigational drug(s) / intervention(s)
Blood sample: Additional blood sampling at the end of ovarian stimulation monitoring (the eve of the oocyte pick-up)
Urine sample: Collection of the first urine in the morning on the day of the oocyte pick-up
Follicular fluid and granulosa cells sample: Collection of follicular fluid and granulosa cells during oocyte pick-up.
Study summary
Synthetic products used in industrial, pharmaceutical, agro-alimentary or agricultural fields are found in our environment. Thus, humans could be simultaneously exposed to several of these pollutants. Furthermore, these environmental agents exert or could exert adverse actions on fertility, by altering gamete and embryo quality through endocrine disruptor effects or through increase in oxidative stress in gonads (cellular pathway known to be involved in several human reproductive pathologies).
In this context, the objectives of the present project are to obtain descriptive and analytical data on woman and oocyte exposure to several environmental agents (bisphenols, ethynylestradiol and glyphosate). The relation between these pollutant measures in follicular fluid and urine (from women receiving follow-up of in vitro fertilization (IVF) protocol in the University hospital of Tours, France) and the oocyte quality, the IVF and pregnancy successes will be studied. Several oxidative stress biomarkers in blood and follicular fluid will be also measured for these women, who will complete a questionnaire on their lifestyles. Finally, thanks to in vitro approaches, the effects and the mechanisms of action (including oxidative stress) of these pollutants (alone or in cocktails) will be studied on granulosa cells from these patients.
Eligibility
Primary outcome measure(s)
- Presence or absence of ethinylestradiol in follicular fluid — Baseline
Assessed by measure of ethinylestradiol in follicular fluid by Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS) - Presence or absence of ethinylestradiol in urine — Baseline
Assessed by measure of ethinylestradiol in urine by Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS) - Presence or absence of bisphenols in follicular fluid — Baseline
Assessed by measure of bisphenols in follicular fluid by Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS) - Presence or absence of bisphenols in urine — Baseline
Assessed by measure of bisphenols in urine by Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS) - Presence or absence of glyphosate in follicular fluid — baseline
Assessed by measure of glyphosate in follicular fluid by Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS) - Presence or absence of glyphosate in urine — baseline
Assessed by measure of glyphosate in urine by Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS) - Concentration of ethinylestradiol in follicular fluid — baseline
Assessed by concentration of ethinylestradiol in follicular fluid by Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS) - Concentration of ethinylestradiol in urine — baseline
Assessed by concentration of ethinylestradiol in urine by Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS) - Concentration of bisphenols in follicular fluid — baseline
Assessed by concentration of bisphenols in follicular fluid by Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS) - Concentration of bisphenols in urine — baseline
Assessed by concentration of bisphenols in urine by Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS) - Concentration of glyphosate in follicular fluid — baseline
Assessed by concentration of glyphosate in follicular fluid by Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS) - Concentration of glyphosate in urine — baseline
Assessed by concentration of glyphosate in urine by Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS)
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Department of Reproductive Medicine and Biology, Univesity Hospital, Tours | Tours | France | Recruiting |
More University Hospital, Tours trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04866329 on ClinicalTrials.gov ↗ ← All trials in France