Female Reproductive ProblemFIVPHENOLNCT02377219
Bisphenol A Exposure, Ovarian Function and Assisted Reproductive Technology Outcome.
A study testing hormonal and blood analysis in people with Female Reproductive Problem and Male Reproductive Problems, run by University Hospital, Toulouse at 8 sites in France.
Trial summary
Our goal is to prospect the relationships between Bisphenol A (BPA) exposure (measured as its free and conjugated forms in blood and urine) and embryo implantation rate (measured as the ratio between the number of gestational sacs and the number of transferred embryos) after assisted reproductive technology. Read more about this study
- Who is it for?
- Ages 28 to 34 years
- Conditions the study is for
- Female Reproductive Problem, Male Reproductive Problems
- What is being tested?
- hormonal and blood analysis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 8 sitesFrance
- Study dates
- Oct 2014to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 28 to 34 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Couples attending an IVF or ICSI attempt whose woman is aged 28 ans to 34 at inclusion time
- Regular menstrual cycles (between 27 and 33 days)
- 1st or 2nd IVF or ICSI attempt with an embryo transfer at D2 or D3
Who cannot join
- couple already included in the study
- ovarian surgery history
- uterine (malformation, diethylstilbestrol (DES) syndrome, adenomyosis…) or systemic pathology that can affect implantation (thrombophilia, antiphospholipids syndrome…)
- chemotherapy history for the woman
- any endocrinopathy (except dysthyroid) in the woman
- any pelvic surgery for the woman in the 3 months preceding inclusion
Show all 9Show fewer
- endometriosis
- ICSI with testicular sperm
- Positive viral load for HIV, hepatitis C virus or hepatitis B virus (HCV or HBV) during the year preceding inclusion in one or both members of the couple
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
University Hospital
Bordeaux, 33076
CHRU Brest Hôpital Morvan, Service de Médecine de la Reproduction
Brest
University Hospital
Dijon, 21000
University Hospital
Lille, 59037
CHU Limoges, Centre d'AMP
Limoges
University Hospital
Nantes, 44093
HOSPITAL
Poissy, 78303
University Hospital
Toulouse, 31052
About this study
Our goal is to prospect the relationships between Bisphenol A (BPA) exposure (measured as its free and conjugated forms in blood and urine) and embryo implantation rate (measured as the ratio between the number of gestational sacs and the number of transferred embryos) after assisted reproductive technology. In order to reduce the confusion factors, the population study is limited to young women (aged 28 to 34), with regular menstrual cycles and without any medical event that could affect the implantation process
Read the detailed description
Among the various suspected adverse effects of BPA on human health, studies on the possible effects of BPA on reproduction are limited. Animal and in vitro studies indicate that BPA exposure can lead to disrupted oocyte maturation, E2 suppression and early pregnancy loss caused by chromosomal abnormalities. In the woman, studies about the consequences of BPA exposure on reproduction is a very difficult task since gametogenesis in the woman spreads over decades, from the intra-uterine life where meiosis is initiated to the end of the reproductive period at menopause. Recently, a decreased survival of human foetal oocytes cultured in vitro in the presence of BPA has been shown suggesting that in vivo exposure in foetal life could affect the ovarian reserve. Furthermore, a negative association between urinary BPA level and serum peak E2, oocyte yield and blastocyst formation has been suggested on a limited population of women performing ART. These results suggest that, in adulthood, both quantity and quality of human oocytes could be affected by BPA exposures. The study aims to respond to these questions by evaluating the relationships between BPA exposition levels and embryo implantation rates (as a marker of oocyte quality) and anti-Mullerian hormon (AMH) levels (as a marker of ovarian reserve) in large population of young adult women performing ART. BPA exposure will be assessed at two times in both blood and urine: 1°) before the ovarian stimulation at the time of ovarian reserve tests and 2°) at the end of the ovarian stimulation the day of the ovarian puncture for IVF.
- Being tested
- hormonal and blood analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hormonal and blood analysisOther
| Study group | Role | What they receive |
|---|---|---|
| couples | Experimental | couples attending an IVF or intra cytoplasmic sperm injection (ICSI) attempt have hormonal and blood analysis Receives: Other: hormonal and blood analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
embryo implantation rate
an ultrasonography between the 5th and 7th week after embryo transfer
Measured: 6 weeks after implantation
Secondary outcomes (1)
serum AMH
Measured: 4 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startOct 2014
- Primary completionJul 2019
- Study completionJul 2019
Why it stopped: Recruitment target not obtained
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Female Reproductive ProblemStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roger LEANDRI, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377219
- Sponsor's protocol ID
- RC31/12/0571
- Other IDs
- PHRC 2012
- Acronym
- FIVPHENOL
- Status last verified
- Jul 2019
- First submitted
- 17 Dec 2013
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Corbel T, Gayrard V, Viguie C, Puel S, Lacroix MZ, Toutain PL, Picard-Hagen N. Bisphenol A disposition in the sheep maternal-placental-fetal unit: mechanisms determining fetal internal exposure. Biol Reprod. 2013 Jul 18;89(1):11. doi: 10.1095/biolreprod.112.106369. Print 2013 Jul.
PubMed 23699389Leandri RD, Gachet A, Pfeffer J, Celebi C, Rives N, Carre-Pigeon F, Kulski O, Mitchell V, Parinaud J. Is intracytoplasmic morphologically selected sperm injection (IMSI) beneficial in the first ART cycle? a multicentric randomized controlled trial. Andrology. 2013 Sep;1(5):692-7. doi: 10.1111/j.2047-2927.2013.00104.x. Epub 2013 Jun 21.
PubMed 23788532
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bisphenol A Exposure, Ovarian Function and Assisted Reproductive Technology Outcome.
- ClinicalTrials.gov ID
- NCT02377219
- Acronym / sponsor ID
- FIVPHENOL / RC31/12/0571
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment target not obtained
- Enrolment
- 350 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 3 Mar 2015 (estimated)
- 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.
Our goal is to prospect the relationships between Bisphenol A (BPA) exposure (measured as its free and conjugated forms in blood and urine) and embryo implantation rate (measured as the ratio between the number of gestational sacs and the number of transferred embryos) after assisted reproductive technology. In order to reduce the confusion factors, the population study is limited to young women (aged 28 to 34), with regular menstrual cycles and without any medical event that could affect the implantation process
Detailed description
Among the various suspected adverse effects of BPA on human health, studies on the possible effects of BPA on reproduction are limited. Animal and in vitro studies indicate that BPA exposure can lead to disrupted oocyte maturation, E2 suppression and early pregnancy loss caused by chromosomal abnormalities. In the woman, studies about the consequences of BPA exposure on reproduction is a very difficult task since gametogenesis in the woman spreads over decades, from the intra-uterine life where meiosis is initiated to the end of the reproductive period at menopause. Recently, a decreased survival of human foetal oocytes cultured in vitro in the presence of BPA has been shown suggesting that in vivo exposure in foetal life could affect the ovarian reserve. Furthermore, a negative association between urinary BPA level and serum peak E2, oocyte yield and blastocyst formation has been suggested on a limited population of women performing ART. These results suggest that, in adulthood, both quantity and quality of human oocytes could be affected by BPA exposures. The study aims to respond to these questions by evaluating the relationships between BPA exposition levels and embryo implantation rates (as a marker of oocyte quality) and anti-Mullerian hormon (AMH) levels (as a marker of ovarian reserve) in large population of young adult women performing ART. BPA exposure will be assessed at two times in both blood and urine: 1°) before the ovarian stimulation at the time of ovarian reserve tests and 2°) at the end of the ovarian stimulation the day of the ovarian puncture for IVF.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| couples | Experimental | Other: hormonal and blood analysiscouples attending an IVF or intra cytoplasmic sperm injection (ICSI) attempt have hormonal and blood analysis |
Who may qualify
- Ages
- 28 to 34 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Couples attending an IVF or ICSI attempt whose woman is aged 28 ans to 34 at inclusion time
- Regular menstrual cycles (between 27 and 33 days)
- 1st or 2nd IVF or ICSI attempt with an embryo transfer at D2 or D3
Key exclusion criteria (9 listed)
- couple already included in the study
- ovarian surgery history
- uterine (malformation, diethylstilbestrol (DES) syndrome, adenomyosis…) or systemic pathology that can affect implantation (thrombophilia, antiphospholipids syndrome…)
- chemotherapy history for the woman
- any endocrinopathy (except dysthyroid) in the woman
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 |
|---|---|---|
| hormonal and blood analysis | Other | couples |
Primary outcome
embryo implantation rate
Time frame: 6 weeks after implantation
an ultrasonography between the 5th and 7th week after embryo transfer
1 secondary outcome
serum AMH
Time frame: 4 days after inclusion
Results and safety
The study was stopped early (reason given: Recruitment target not obtained). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Background: PubMed 23699389Corbel T, Gayrard V, Viguie C, Puel S, Lacroix MZ, Toutain PL, Picard-Hagen N. Bisphenol A disposition in the sheep maternal-placental-fetal unit: mechanisms determining fetal internal exposure. Biol Reprod. 2013 Jul 18;89(1):11. doi: 10.1095/biolreprod.112.106369. Print 2013 Jul.
- Background: PubMed 23788532Leandri RD, Gachet A, Pfeffer J, Celebi C, Rives N, Carre-Pigeon F, Kulski O, Mitchell V, Parinaud J. Is intracytoplasmic morphologically selected sperm injection (IMSI) beneficial in the first ART cycle? a multicentric randomized controlled trial. Andrology. 2013 Sep;1(5):692-7. doi: 10.1111/j.2047-2927.2013.00104.x. Epub 2013 Jun 21.
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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. This study is not recruiting at the moment.
Roger LEANDRI, MD principal investigator
University Hospital, Toulouse
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hormonal and blood analysis in people with Female Reproductive Problem and Male Reproductive Problems, run by University Hospital, Toulouse at 8 sites 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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
The study was stopped early (reason given: Recruitment target not obtained). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
embryo implantation rate (time frame: 6 weeks after implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02377219, which also lists 2 linked publications.
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 15 Jul 2019.