Female Fertility, Environmental Agents and Stress Oxidant

NCT04866329 | Recruiting

• 2 other identifiers: DR2002092020-A03241-38
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Infertility

Keywords

Environmental pollutants; Bisphenols; Ethynylestradiol; Glyphosate; Oxidative stress; Oocyte and embryo quality; In vitro fertilization; Pregnancy; Follicular fluid and urine biomarkers

Outcome Measures

Primary Outcomes (12)

• 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)

  Baseline

• 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)

  Baseline

• 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)

  Baseline

• 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)

  Baseline

• Presence or absence of glyphosate in follicular fluid

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

  baseline

• Presence or absence of glyphosate in urine

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

  baseline

• Concentration of ethinylestradiol in follicular fluid

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

  baseline

• Concentration of ethinylestradiol in urine

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

  baseline

• Concentration of bisphenols in follicular fluid

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

  baseline

• Concentration of bisphenols in urine

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

  baseline

• Concentration of glyphosate in follicular fluid

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

  baseline

• Concentration of glyphosate in urine

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

  baseline

Secondary Outcomes (22)

• Oocyte quality

  baseline

• Embryo quality

  Day 2 and day 5/6 after oocyte pick up

• Embryo implantation success (pregnancy success)

  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

  baseline

• Oxidative stress biomarkers in follicular fluid

  Baseline

Study Arms (1)

In Vitro Fertilisation protocol

Women followed in the department for an in vitro fertilisation protocol

Other: Blood sample; Other: Urine sample; Other: Follicular fluid and granulosa cells sample

Interventions

Blood sample OTHER

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

In Vitro Fertilisation protocol

Urine sample OTHER

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

In Vitro Fertilisation protocol

Follicular fluid and granulosa cells sample OTHER

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

In Vitro Fertilisation protocol

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women followed in the department for an in vitro fertilisation procedure

You may qualify if:

• Woman aged 18 to 43 years old
• First oocyte puncture (IVF rank = 1)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

Department of Reproductive Medicine and Biology, Univesity Hospital, Tours

Tours, 37044, France

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Fabrice GUERIF, MD-PhD

  University Hospital, Tours

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabrice GUERIF, MD-PhD

CONTACT

02.47.47.84.76; fabrice.guerif@univ-tours.fr

Virginie MAILLARD, PhD

CONTACT

02.47.42.79.71; virginie.maillard@inrae.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: April 29, 2021
• Study Start: December 8, 2021
• Primary Completion (Estimated): December 8, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 25, 2024

Record last verified: 2024-07

Locations

FR (1)