Human Papilloma VirusHPV-AMPNCT06550531
Impact of Human Papillomavirus Carriage on IVF/ICSI Results (HPV AMP)
An observational study of Human Papilloma Virus and Infertility, Female, run by University Hospital, Brest at 1 site in France.
Trial summary
The prevalence of the papilloma virus in the general population is 12%. This virus is known to impair male fertility but its impact on female infertility remains uncertain. This is a public health problem since there is a vaccination protocol. Read more about this study
- Who is it for?
- Ages 25 to 38 years, women only
- Conditions the study is for
- Human Papilloma Virus, Infertility, Female
- How many people
- 618 participants
- Where
- 1 siteFrance
- Study dates
- 4 Feb 2022to 4 Feb 2026
- Phase
- Observational
- 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 25 to 38 years
- Women only
- No healthy volunteers
- Adult
Study population: The population study is a population of infertile women who are consulting in our center of Reproduction Médicine in CHU Brest.
Who may be able to join
- all etiology of infertility AMH > ou = à 1.1 ng/ml First ou second protocol of IVF between 25 years and 37 years and 11 months
Who cannot join
- Age < 25 y Age > ou = 38 y AMH < 1.1 ng/ml patient under juridic protection rejection of participation
Trial locations and contacts
1 site in 1 country.
Anne-Solenn JACAMON contact
France1 site, 1 recruiting
- Recruiting
CHRU de Brest
Brest, 29609
Sarah BOUEE, sarah.bouee@chu-brest.fr
About this study
Official title: Impact of Human Papillomavirus Carriage on IVF/ICSI Results at Brest University Hospital
The prevalence of the papilloma virus in the general population is 12%. This virus is known to impair male fertility but its impact on female infertility remains uncertain. This is a public health problem since there is a vaccination protocol. Demonstrating the impact of the human papillomavirus on fertility would be an argument in favor of vaccination.
Read the detailed description
This is a single-center prospective study in the assisted reproduction center of Brest University Hospital. All new patients coming to consult will be offered participation in the study. The HPV test will be updated if it is older than 12 months. We will analyze stimulation results and pregnancy outcomes according to HPV status. Inclusions will take place over 3 years
- Conditions
- Human Papilloma Virus, Infertility, Female
- Medical subject headings
- Infertility, Female
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate after fresh eSET by HPV status
A clinical pregancy is the visualisation of a gestational sac inside the uterus after 6 weeks of gestation
Measured: 1 year
Secondary outcomes (2)
IVF issues
oocytes number, embryos number, fecondation rate, implantation rate
Measured: 1 year
Positive HPV rate
number of women who have a positive HPV test before IVF procedure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start4 Feb 2022
- Primary completion4 Feb 2026 (estimated)
- Study completion4 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma VirusStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- 618 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550531
- Sponsor's protocol ID
- 29BRC21.0363 - HPV AMP
- Acronym
- HPV-AMP
- Status last verified
- Aug 2024
- First submitted
- 31 Mar 2022
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Human Papillomavirus Carriage on IVF/ICSI Results at Brest University Hospital
- ClinicalTrials.gov ID
- NCT06550531
- Acronym / sponsor ID
- HPV-AMP / 29BRC21.0363 - HPV AMP
- Conditions
- Human Papilloma Virus, Infertility, Female
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 618 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 4 Feb 2022 (actual)
- Primary completion
- 4 Feb 2026 (estimated)
- Study completion
- 4 Feb 2026 (estimated)
- First posted
- 13 Aug 2024 (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.
The prevalence of the papilloma virus in the general population is 12%. This virus is known to impair male fertility but its impact on female infertility remains uncertain. This is a public health problem since there is a vaccination protocol. Demonstrating the impact of the human papillomavirus on fertility would be an argument in favor of vaccination.
Detailed description
This is a single-center prospective study in the assisted reproduction center of Brest University Hospital. All new patients coming to consult will be offered participation in the study. The HPV test will be updated if it is older than 12 months. We will analyze stimulation results and pregnancy outcomes according to HPV status. Inclusions will take place over 3 years
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The population study is a population of infertile women who are consulting in our center of Reproduction Médicine in CHU Brest.
Key inclusion criteria (1 listed)
- all etiology of infertility AMH > ou = à 1.1 ng/ml First ou second protocol of IVF between 25 years and 37 years and 11 months
Key exclusion criteria (1 listed)
- Age < 25 y Age > ou = 38 y AMH < 1.1 ng/ml patient under juridic protection rejection of participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
clinical pregnancy rate after fresh eSET by HPV status
Time frame: 1 year
A clinical pregancy is the visualisation of a gestational sac inside the uterus after 6 weeks of gestation
2 secondary outcomes
IVF issues
Time frame: 1 year
Positive HPV rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
Anne-Solenn JACAMON contact
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 Human Papilloma Virus and Infertility, Female, run by University Hospital, Brest 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah BOUEE (02 98 22 39 70, sarah.bouee@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical pregnancy rate after fresh eSET by HPV status (time frame: 1 year). 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 13 Aug 2024.