Health TrialsbyHealthPanel

Female Fertility, Environmental Agents and Stress Oxidant

ConditionFemale Infertility
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-43
SponsorUniversity Hospital, Tours

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Woman aged 18 to 43 years old

First oocyte puncture (IVF rank = 1)

Disqualifiers

Opposition to data processing

IVF rank equal or greater than 2

Egg donation

Intracytoplasmic Sperm Injection with testicular biopsy

Trial population

Women followed in the department for an in vitro fertilisation procedure

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood sample

    Other intervention

    Additional blood sampling at the end of ovarian stimulation monitoring (the eve of the oocyte pick-up)

  • Urine sample

    Other intervention

    Collection of the first urine in the morning on the day of the oocyte pick-up

  • Follicular fluid and granulosa cells sample

    Other intervention

    Collection of follicular fluid and granulosa cells during oocyte pick-up.

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: In Vitro Fertilisation protocol3 interventions

Trial outcomes

Primary outcomes

1

Presence or absence of ethinylestradiol in follicular fluid

Assessed by measure of ethinylestradiol in follicular fluid by Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS)

Time frame
Baseline
2

Presence or absence of ethinylestradiol in urine

Assessed by measure of ethinylestradiol in urine by Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS)

Time frame
Baseline
3

Presence or absence of bisphenols in follicular fluid

Assessed by measure of bisphenols in follicular fluid by Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS)

Time frame
Baseline
4

Presence or absence of bisphenols in urine

Assessed by measure of bisphenols in urine by Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS)

Time frame
Baseline

Secondary outcomes

1

Oocyte quality

Assessed by nuclear maturity of each collected punctured oocyte

Time frame
baseline
2

Embryo quality

Assessed by in vitro early embryo developmental competence of each punctured oocyte (Day 2 embryo morphology, ability to reach the blastocyst stage, Day 5/6 blastocyst morphology, blastocyst outcome (transfer, freezing, discarding)

Time frame
Day 2 and day 5/6 after oocyte pick up
3

Embryo implantation success (pregnancy success)

Assessed by confirmation of a clinical pregnancy (blood beta human chorionic gonadotropin assay: \> 1000 Unity Intenational /L), by confirmation of on-going pregnancy (ultrasound measure of foetus cardiac activity) and by confirmation delivery of live and healthy birth

Time frame
From day 7 after embryo transfer for beta hCG assay, at 8 weeks of amenorrhea for foetus cardiac activity and after birth
4

Oxidative stress biomarkers in follicular fluid

Assessed by measure of antioxidant vitamins (carotenoids, vitamin E, retinol) by High Performance Liquid Chromatography

Time frame
baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Tours

Lead sponsor

Source ClinicalTrials.gov
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