Female Fertility, Environmental Agents and Stress Oxidant
NCT ID: NCT04866329
Last Updated: 2024-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2021-12-08
2027-12-31
Brief Summary
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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.
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Detailed Description
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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 -80°C 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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In Vitro Fertilisation protocol
Women followed in the department for an in vitro fertilisation protocol
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* First oocyte puncture (IVF rank = 1)
Exclusion Criteria
* IVF rank equal or greater than 2
* Egg donation
* Intracytoplasmic Sperm Injection with testicular biopsy
* Intracytoplasmic Sperm Injection with self-preservation straw
* Sperm donation
18 Years
43 Years
FEMALE
No
Sponsors
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University Hospital, Tours
OTHER
Responsible Party
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Principal Investigators
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Fabrice GUERIF, MD-PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Tours
Locations
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Department of Reproductive Medicine and Biology, Univesity Hospital, Tours
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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Fabrice GUERIF, MD-PhD
Role: primary
Claire VIGNAULT, MD
Role: backup
Other Identifiers
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2020-A03241-38
Identifier Type: OTHER
Identifier Source: secondary_id
DR200209
Identifier Type: -
Identifier Source: org_study_id
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