NCT04866329 Female Fertility, Environmental Agents and Stress Oxidant
| NCT ID | NCT04866329 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Tours |
| Condition | Female Infertility |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2021-12-08 |
| Primary Completion | 2026-12-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2021-12-08 with a primary completion date of 2026-12-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Woman aged 18 to 43 years old * First oocyte puncture (IVF rank = 1) Exclusion Criteria: * Opposition to data processing * IVF rank equal or greater than 2 * Egg donation * Intracytoplasmic Sperm Injection with testicular biopsy * Intracytoplasmic Sperm Injection with self-preservation straw * Sperm donation
Contact & Investigator
Fabrice GUERIF, MD-PhD
PRINCIPAL INVESTIGATOR
University Hospital, Tours
Frequently Asked Questions
Who can join the NCT04866329 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 43 Years, studying Female Infertility. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04866329 currently recruiting?
Yes, NCT04866329 is actively recruiting participants. Contact the research team at fabrice.guerif@univ-tours.fr for enrollment information.
Where is the NCT04866329 trial being conducted?
This trial is being conducted at Tours, France.
Who is sponsoring the NCT04866329 clinical trial?
NCT04866329 is sponsored by University Hospital, Tours. The principal investigator is Fabrice GUERIF, MD-PhD at University Hospital, Tours. The trial plans to enroll 500 participants.