Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04866329
Status:
RECRUITING
Last Update Posted:
2022-02-23
First Post:
2021-03-23
Brief Title:
Female Fertility Environmental Agents and Stress Oxidant
Sponsor:
University Hospital Tours
Organization:
University Hospital Tours
Study Overview
Official Title:
FERTilité féminine Agents ENvironnementaux et Stress OXydant
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FERTENOX
Brief 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
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
Detailed Description:
After being informed about the project Fertenox during a meeting describing about the Fecondation In Vitro protocol all women patients not opposing to participate in the study and to use individual information will be included in the research during the usual bacteriological exam performed 1-2 months before oocyte pick up in the University hospital They will receive the questionnaire on their lifestyle during this exam
On the eve of the oocyte pick up at the end of ovarian stimulation during the usual blood collection three additional tubes of blood will be collected for each patient in the University hospital Women will also receive the screw-top container for morning-after urine sample and the completion of the lifestyle questionnaire will be checked some advices will be done if necessary to help patients to fill out the questionnaire Samples will be treated aliquoted and stored according to requirements the same day
The day of the oocyte pick up the first morning urine will be collected by patients at home or otherwise in the hospital The completed questionnaire will be recovered and follicular fluid and granulosa cells will be collected for each woman Samples will be aliquoted and stored according to requirements the same day Granulosa cells will be cultured for in vitro approaches in research labs the same day
Tubes of blood urine and follicular fluid will be coded and kept at -80C in the University hospital until their shipment to laboratories where analyses of pollutants bisphenols ethynylestradiol and glyphosate and analyses of oxidative stress biomarkers antioxidant vitamins FRAP activity of several enzymes catalase superoxide dismutase glutathione peroxidase and oxidized lipids will be performed
On the eve of the oocyte pick up at the end of ovarian stimulation during the usual blood collection three additional tubes of blood will be collected for each patient in the University hospital Women will also receive the screw-top container for morning-after urine sample and the completion of the lifestyle questionnaire will be checked some advices will be done if necessary to help patients to fill out the questionnaire Samples will be treated aliquoted and stored according to requirements the same day
The day of the oocyte pick up the first morning urine will be collected by patients at home or otherwise in the hospital The completed questionnaire will be recovered and follicular fluid and granulosa cells will be collected for each woman Samples will be aliquoted and stored according to requirements the same day Granulosa cells will be cultured for in vitro approaches in research labs the same day
Tubes of blood urine and follicular fluid will be coded and kept at -80C in the University hospital until their shipment to laboratories where analyses of pollutants bisphenols ethynylestradiol and glyphosate and analyses of oxidative stress biomarkers antioxidant vitamins FRAP activity of several enzymes catalase superoxide dismutase glutathione peroxidase and oxidized lipids will be performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-A03241-38 | OTHER | IdRCB | None |