Female InfertilityFERTENOXNCT04866329
Female Fertility, Environmental Agents and Stress Oxidant
An observational study of Female Infertility, run by University Hospital, Tours at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Female Infertility
- What is being tested?
- Blood sample, Urine sample and Follicular fluid and granulosa cells sample
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 8 Dec 2021to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- Women only
- No healthy volunteers
- Adult
Study population: Women followed in the department for an in vitro fertilisation procedure
Who may be able to join
- Woman aged 18 to 43 years old
- First oocyte puncture (IVF rank = 1)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Department of Reproductive Medicine and Biology, Univesity Hospital, Tours
Tours, 37044
Fabrice GUERIF, MD-PhD
Claire VIGNAULT, MD
About this study
Official title: FERTilité féminine, Agents ENvironnementaux et Stress OXydant
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.
Read the 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.
- Conditions
- Female Infertility
- Being tested
- Blood sample, Urine sample, Follicular fluid and granulosa cells sample
- Keywords
- Environmental pollutants, Bisphenols, Ethynylestradiol, Glyphosate, Oxidative stress, Oocyte and embryo quality, In vitro fertilization, Pregnancy, Follicular fluid and urine biomarkers
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Additional blood sampling at the end of ovarian stimulation monitoring (the eve of the oocyte pick-up)
Urine sampleOther
Collection of the first urine in the morning on the day of the oocyte pick-up
Follicular fluid and granulosa cells sampleOther
Collection of follicular fluid and granulosa cells during oocyte pick-up.
| Study group | Role | What they receive |
|---|---|---|
| In Vitro Fertilisation protocol | Women followed in the department for an in vitro fertilisation protocol Receives: Other: Blood sample; Other: Urine sample; Other: Follicular fluid and granulosa cells sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: baseline
Concentration of ethinylestradiol in urine
Assessed by concentration of ethinylestradiol in urine by Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS)
Measured: 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)
Measured: baseline
Concentration of bisphenols in urine
Assessed by concentration of bisphenols in urine by Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS)
Measured: 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)
Measured: baseline
Concentration of glyphosate in urine
Assessed by concentration of glyphosate in urine by Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS)
Measured: baseline
Secondary outcomes (22)
Oocyte quality
Assessed by nuclear maturity of each collected punctured oocyte
Measured: baseline
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)
Measured: Day 2 and day 5/6 after oocyte pick up
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
Measured: 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
Assessed by measure of antioxidant vitamins (carotenoids, vitamin E, retinol) by High Performance Liquid Chromatography
Measured: baseline
Oxidative stress biomarkers in follicular fluid
Assessed by measure of oxidized lipids (isoprostanoids) by LC-MS/MS
Measured: Baseline
Oxidative stress biomarkers in follicular fluid
Assessed by measure of antioxidant power (FRAP: Ferric ion Reducing Antioxidant Power) by spectrophotometry
Measured: Baseline
Oxidative stress biomarkers in follicular fluid
Assessed by measure of glutathione peroxidase activity by spectrophometry
Measured: Baseline
Oxidative stress biomarkers in blood
Assessed by measure of plasma antioxidant vitamins (carotenoids, vitamin E, retinol) by HPLC
Measured: On the eve of baseline
Oxidative stress biomarkers in blood
Assessed by measure of plasma oxidized lipids (isoprostanoids) by LC-MS/M
Measured: On the eve of baseline
Oxidative stress biomarkers in blood
Assessed by measure of plasma antioxidant power (FRAP) by spectrophotometry
Measured: On the eve of baseline
Oxidative stress biomarkers in blood
Assessed by measure of activities of glutathione peroxidase, catalase and superoxide dismutase in red blood cells by UV and visible spectrophometry
Measured: On the eve of baseline
Oxidative stress biomarkers in urine
Assessed by measure of oxidized lipids (isoprostanoids) by LC-MS/MS
Measured: baseline
Information on woman lifestyles
Assessed by a questionnaire on sociodemographic characteristics, smoking, physical activity, professional and environmental expositions, consumption of dietary supplements (antioxidants), consumption of drinks (tap water, from plastic bottle, cans...), food reheating habit, consumption of food from tin box, use of hygiene and cosmetic products...
Measured: The 3 last months of lifestyles before baseline
Pollutant effects on patient granulosa cells in vitro
Assessed on cellular viability (CCK8, live-dead assay)
Measured: after 24 or 48h of exposure
Pollutant effects on patient granulosa cells in vitro
Assessed on proliferation (BrdU)
Measured: after 24 or 48h of exposure
Pollutant effects on patient granulosa cells in vitro
Assessed on steroid production (ELISA, LC-MS)
Measured: after 48 or 72h of exposure
Pollutant effects on patient granulosa cells in vitro
Assessed on energetic metabolism (mitochondrial and glycolytic activities by Seahorse and Omnilog assays)
Measured: after 1 or 24h of exposure
Pollutant effects on patient granulosa cells in vitro
Assessed on oxidative stress biomarkers (reactive oxygen production, Nrf2 nuclear translocation by confocal microscopy, cytometry and fluorimetry)
Measured: after 5, 6 or 24h of exposure
Pollutant effects on patient granulosa cells in vitro
Assessed on protein expression (Western Blotting) of several markers of the studied functions (including oxidative stress)
Measured: after 24, 48 or 72h of exposure
Pollutant effects on patient granulosa cells in vitro
Assessed on gene expression (RNAseq and Quantitative Reverse Transcription-PCR) of several markers of the studied functions (including oxidative stress)
Measured: after 6 or 24h of exposure
Pollutant effects on patient granulosa cells in vitro
Assessed on protein expression (Western Blotting ) of signaling pathways
Measured: after 1, 5, 10, 30 and 60 min of exposure
Pollutant effects on patient granulosa cells in vitro
Assessed on gene expression (RNAseq and qRT-PCR) of signaling pathways
Measured: after 6h of exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start8 Dec 2021
- Primary completion8 Dec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female InfertilityStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrice GUERIF, MD-PhD, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866329
- Sponsor's protocol ID
- DR200209
- Other IDs
- 2020-A03241-38
- Acronym
- FERTENOX
- Status last verified
- Jul 2024
- First submitted
- 23 Mar 2021
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FERTilité féminine, Agents ENvironnementaux et Stress OXydant
- ClinicalTrials.gov ID
- NCT04866329
- Acronym / sponsor ID
- FERTENOX / DR200209
- Conditions
- Female Infertility
- Keywords
- Environmental pollutants, Bisphenols, Ethynylestradiol, Glyphosate, Oxidative stress, Oocyte and embryo quality, In vitro fertilization, Pregnancy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 8 Dec 2021 (actual)
- Primary completion
- 8 Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 29 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| In Vitro Fertilisation protocol | – | Other: Blood sample, Other: Urine sample, Other: Follicular fluid and granulosa cells sampleWomen followed in the department for an in vitro fertilisation protocol |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women followed in the department for an in vitro fertilisation procedure
Key inclusion criteria (2 listed)
- Woman aged 18 to 43 years old
- First oocyte puncture (IVF rank = 1)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleAdditional blood sampling at the end of ovarian stimulation monitoring (the eve of the oocyte pick-up) | Other | In Vitro Fertilisation protocol |
| Urine sampleCollection of the first urine in the morning on the day of the oocyte pick-up | Other | In Vitro Fertilisation protocol |
| Follicular fluid and granulosa cells sampleCollection of follicular fluid and granulosa cells during oocyte pick-up. | Other | In Vitro Fertilisation protocol |
Primary outcome
Presence or absence of ethinylestradiol in follicular fluid
Time frame: Baseline
Assessed by measure of ethinylestradiol in follicular fluid by Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS)
Presence or absence of ethinylestradiol in urine
Time frame: Baseline
Assessed by measure of ethinylestradiol in urine by Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS)
Presence or absence of bisphenols in follicular fluid
Time frame: Baseline
Assessed by measure of bisphenols in follicular fluid by Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS)
Presence or absence of bisphenols in urine
Time frame: Baseline
Assessed by measure of bisphenols in urine by Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS)
Presence or absence of glyphosate in follicular fluid
Time frame: baseline
Assessed by measure of glyphosate in follicular fluid by Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS)
Presence or absence of glyphosate in urine
Time frame: baseline
Assessed by measure of glyphosate in urine by Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS)
Concentration of ethinylestradiol in follicular fluid
Time frame: baseline
Assessed by concentration of ethinylestradiol in follicular fluid by Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS)
Concentration of ethinylestradiol in urine
Time frame: baseline
Assessed by concentration of ethinylestradiol in urine by Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS)
Concentration of bisphenols in follicular fluid
Time frame: baseline
Assessed by concentration of bisphenols in follicular fluid by Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS)
Concentration of bisphenols in urine
Time frame: baseline
Assessed by concentration of bisphenols in urine by Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS)
Concentration of glyphosate in follicular fluid
Time frame: baseline
Assessed by concentration of glyphosate in follicular fluid by Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS)
Concentration of glyphosate in urine
Time frame: baseline
Assessed by concentration of glyphosate in urine by Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS)
22 secondary outcomes
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
Information on woman lifestyles
Time frame: The 3 last months of lifestyles before baseline
Pollutant effects on patient granulosa cells in vitro
Time frame: after 24 or 48h of exposure
Pollutant effects on patient granulosa cells in vitro
Time frame: after 24 or 48h of exposure
Pollutant effects on patient granulosa cells in vitro
Time frame: after 48 or 72h of exposure
Pollutant effects on patient granulosa cells in vitro
Time frame: after 1 or 24h of exposure
Pollutant effects on patient granulosa cells in vitro
Time frame: after 5, 6 or 24h of exposure
Pollutant effects on patient granulosa cells in vitro
Time frame: after 24, 48 or 72h of exposure
Pollutant effects on patient granulosa cells in vitro
Time frame: after 6 or 24h of exposure
Pollutant effects on patient granulosa cells in vitro
Time frame: after 1, 5, 10, 30 and 60 min of exposure
Pollutant effects on patient granulosa cells in vitro
Time frame: after 6h of exposure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fabrice GUERIF, MD-PhD principal investigator
University Hospital, Tours
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Female Infertility, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabrice GUERIF, MD-PhD (02.47.47.84.76 ext. +33, fabrice.guerif@univ-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of ethinylestradiol in follicular fluid (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.