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Recruiting NCT04866329

Female Fertility, Environmental Agents and Stress Oxidant

— Observational Female Infertility

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood sample, Urine sample, Follicular fluid and granulosa cells sample.
Who it may be relevant to
Registry conditions: Female Infertility. Basic parameters: 18 years — 43 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

FERTilité féminine, Agents ENvironnementaux et Stress OXydant

Overview

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.

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 -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.

Interventions

  • Other Blood sample
    Additional blood sampling at the end of ovarian stimulation monitoring (the eve of the oocyte pick-up)
  • Other Urine sample
    Collection of the first urine in the morning on the day of the oocyte pick-up
  • Other Follicular fluid and granulosa cells sample
    Collection of follicular fluid and granulosa cells during oocyte pick-up.

Primary outcome measures

  • Presence or absence of ethinylestradiol in follicular fluid [Time frame: Baseline]
  • Presence or absence of ethinylestradiol in urine [Time frame: Baseline]
  • Presence or absence of bisphenols in follicular fluid [Time frame: Baseline]
  • Presence or absence of bisphenols in urine [Time frame: Baseline]
  • Presence or absence of glyphosate in follicular fluid [Time frame: baseline]
  • Presence or absence of glyphosate in urine [Time frame: baseline]
  • Concentration of ethinylestradiol in follicular fluid [Time frame: baseline]
  • Concentration of ethinylestradiol in urine [Time frame: baseline]
  • Concentration of bisphenols in follicular fluid [Time frame: baseline]
  • Concentration of bisphenols in urine [Time frame: baseline]
Secondary outcome measures (12)
  • Oocyte quality [Time frame: baseline]
  • Embryo quality [Time frame: Day 2 and day 5/6 after oocyte pick up]
  • Embryo implantation success (pregnancy success) [Time frame: From day 7 after embryo transfer for beta hCG assay, at 8 weeks of amenorrhea for foetus cardiac activity and after birth]
  • Oxidative stress biomarkers in follicular fluid [Time frame: baseline]
  • Oxidative stress biomarkers in follicular fluid [Time frame: Baseline]
  • Oxidative stress biomarkers in follicular fluid [Time frame: Baseline]
  • Oxidative stress biomarkers in follicular fluid [Time frame: Baseline]
  • Oxidative stress biomarkers in blood [Time frame: On the eve of baseline]
  • Oxidative stress biomarkers in blood [Time frame: On the eve of baseline]
  • Oxidative stress biomarkers in blood [Time frame: On the eve of baseline]
  • Oxidative stress biomarkers in blood [Time frame: On the eve of baseline]
  • Oxidative stress biomarkers in urine [Time frame: baseline]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Department of Reproductive Medicine and Biology, Univesity Hospital, Tours — Tours

Identifiers

NCT: NCT04866329 · DR200209 · 2020-A03241-38

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗