Human Papillomavirus (HPV)AMPAMAVIRNCT02524223
Prevalence of HPV Transmission During Medically Assisted Procreation Procedures
A study testing Systematic HPV DNA assay in semen and cervicovaginal scrape, Systematic HPV DNA cervicovaginal scrape and systematic HPV Status in newborns in case of pregnancy in people with Human Papillomavirus (HPV) and Medically Assisted Procreation (MAP), run by Centre Hospitalier Universitaire de Saint Etienne at 5 sites in France.
Trial summary
Human PapillomaVirus (HPV) are ones of the main causal agents of sexually transmitted diseases. Numerous HPV genotypes such as 16, 18, 31 or 45 are considered to be at high risk of oncogenicity especially for the anal and cervical mucosa. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Papillomavirus (HPV), Medically Assisted Procreation (MAP), Infertility
- What is being tested?
- Systematic HPV DNA assay in semen and cervicovaginal scrape, Systematic HPV DNA cervicovaginal scrape and systematic HPV Status in newborns in case of pregnancy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 915 participants
- Where
- 5 sitesFrance
- Study dates
- 12 Jul 2012to 22 Feb 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18
- Age under 40 for women
- Signed informed consent by both members of the couple
- Medical indication of MAP by AI (artificial insemination), IVF(in vitro fertilization) or ICSI (intracytoplasmic sperm injection) method
- Well understanding of information letter
Who cannot join
- Age over 40 for women
- Informed consent form not signed by one or both partners
- Co-infection of one of the partners or both by HIV (human immunodeficiency virus) , HBV (hepatitis B virus) and/or HCV (hepatitis C virus)
- IVF by only frozen embryo transfer at the time of inclusion
- Severe oligospermia in male partner (<500 000 sperm cells)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Hôpital Jean VERDIER
Bondy, 93140
CHU de BORDEAUX
Bordeaux, 33000
CHU de CLERMONT-FERRAND
Clermont-Ferrand, 63000
Hôpital BICHAT
Paris, 75018
CHU de SAINT-ETIENNE
Saint-Etienne, 42055
About this study
Human PapillomaVirus (HPV) are ones of the main causal agents of sexually transmitted diseases. Numerous HPV genotypes such as 16, 18, 31 or 45 are considered to be at high risk of oncogenicity especially for the anal and cervical mucosa. At the present time, no recommendations exist on the risk related to HPV during Medically Assisted Procreation (MAP) procedures. The main objective of this prospective multicentric cohort study is to evaluate the prevalence of transmission of HPV via the semen during MAP program. Secondary objectives are to evaluate (1) the prevalence of HPV DNA in the sperm fractions of men enrolled in MAP, (2) the efficacy of spermatozoal pellet preparation procedures to eliminate HPV, (3) the correlation between HPV and male infertility and (4) the correlation between HPV and success rate of procreation. Results could contribute to revise guidelines of MAP procedures and HPV vaccination policy.
- Being tested
- Systematic HPV DNA assay in semen and cervicovaginal scrape, Systematic HPV DNA cervicovaginal scrape, systematic HPV Status in newborns in case of pregnancy
- Keywords
- medically assisted procreation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systematic HPV DNA assay in semen and cervicovaginal scrapeOther
Screening of HPV status at the genital level of males enrolled in MAP program.
Systematic HPV DNA cervicovaginal scrapeOther
Screening of HPV status at the genital level of females enrolled in MAP program.
systematic HPV Status in newborns in case of pregnancyOther
| Study group | Role | What they receive |
|---|---|---|
| Population of couples candidate for MAP program | Other | MAP = medically assisted procreation Receives: Other: Systematic HPV DNA assay in semen and cervicovaginal scrape; Other: Systematic HPV DNA cervicovaginal scrape; Other: systematic HPV Status in newborns in case of pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of HPV DNA on a swab sampled in the throat of newborns from one or two parents detected positive for HPV in semen and/or cervicovaginal scrape
Measured: at birth
Secondary outcomes (5)
Presence of HPV DNA in seminal fractions: seminal plasma, sperm cells dedicated to MAP
Measured: At the time of enrollment, during MAP procedures and at birth (in case of)
Quantitative et qualitative parameters of spermogram analysis: volume of the ejaculate, number, mobility and morphology of sperm cells according to WHO criteria)
Measured: At the time of enrollment, during MAP procedures and at birth (in case of)
Genotype of HPV
Measured: At the time of enrollment, during MAP procedures and at birth (in case of)
Presence of HPV DNA in ovocytes samples and in embryo culture media
Measured: At the time of enrollment, during MAP procedures and at birth (in case of)
Quantitative and qualitative parameters of MAP procedures: fertilization rate, number of ovocytes, number of embryos…
Measured: At the time of enrollment, during MAP procedures and at birth (in case of)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study start12 Jul 2012
- Primary completion22 Feb 2016
- Study completion22 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus (HPV)Studies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 915 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Thomas BOURLET, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02524223
- Sponsor's protocol ID
- 1108144
- Other IDs
- 2011-A01337-34
- Acronym
- AMPAMAVIR
- Status last verified
- Sep 2018
- First submitted
- 13 Aug 2015
- Last updated
- 24 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of HPV Transmission During Medically Assisted Procreation Procedures
- ClinicalTrials.gov ID
- NCT02524223
- Acronym / sponsor ID
- AMPAMAVIR / 1108144
- Keywords
- medically assisted procreation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 915 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 12 Jul 2012 (actual)
- Primary completion
- 22 Feb 2016 (actual)
- Study completion
- 22 Feb 2016 (actual)
- First posted
- 14 Aug 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.
Human PapillomaVirus (HPV) are ones of the main causal agents of sexually transmitted diseases. Numerous HPV genotypes such as 16, 18, 31 or 45 are considered to be at high risk of oncogenicity especially for the anal and cervical mucosa. At the present time, no recommendations exist on the risk related to HPV during Medically Assisted Procreation (MAP) procedures. The main objective of this prospective multicentric cohort study is to evaluate the prevalence of transmission of HPV via the semen during MAP program. Secondary objectives are to evaluate (1) the prevalence of HPV DNA in the sperm fractions of men enrolled in MAP, (2) the efficacy of spermatozoal pellet preparation procedures to eliminate HPV, (3) the correlation between HPV and male infertility and (4) the correlation between HPV and success rate of procreation. Results could contribute to revise guidelines of MAP procedures and HPV vaccination policy.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Population of couples candidate for MAP program | Other | Other: Systematic HPV DNA assay in semen and cervicovaginal scrape, Other: Systematic HPV DNA cervicovaginal scrape, Other: systematic HPV Status in newborns in case of pregnancyMAP = medically assisted procreation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age over 18
- Age under 40 for women
- Signed informed consent by both members of the couple
- Medical indication of MAP by AI (artificial insemination), IVF(in vitro fertilization) or ICSI (intracytoplasmic sperm injection) method
- Well understanding of information letter
Key exclusion criteria (5 listed)
- Age over 40 for women
- Informed consent form not signed by one or both partners
- Co-infection of one of the partners or both by HIV (human immunodeficiency virus) , HBV (hepatitis B virus) and/or HCV (hepatitis C virus)
- IVF by only frozen embryo transfer at the time of inclusion
- Severe oligospermia in male partner (<500 000 sperm cells)
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 |
|---|---|---|
| Systematic HPV DNA assay in semen and cervicovaginal scrapeScreening of HPV status at the genital level of males enrolled in MAP program. | Other | Population of couples candidate for MAP program |
| Systematic HPV DNA cervicovaginal scrapeScreening of HPV status at the genital level of females enrolled in MAP program. | Other | Population of couples candidate for MAP program |
| systematic HPV Status in newborns in case of pregnancy | Other | Population of couples candidate for MAP program |
Primary outcome
Presence of HPV DNA on a swab sampled in the throat of newborns from one or two parents detected positive for HPV in semen and/or cervicovaginal scrape
Time frame: at birth
5 secondary outcomes
Presence of HPV DNA in seminal fractions: seminal plasma, sperm cells dedicated to MAP
Time frame: At the time of enrollment, during MAP procedures and at birth (in case of)
Quantitative et qualitative parameters of spermogram analysis: volume of the ejaculate, number, mobility and morphology of sperm cells according to WHO criteria)
Time frame: At the time of enrollment, during MAP procedures and at birth (in case of)
Genotype of HPV
Time frame: At the time of enrollment, during MAP procedures and at birth (in case of)
Presence of HPV DNA in ovocytes samples and in embryo culture media
Time frame: At the time of enrollment, during MAP procedures and at birth (in case of)
Quantitative and qualitative parameters of MAP procedures: fertilization rate, number of ovocytes, number of embryos…
Time frame: At the time of enrollment, during MAP procedures and at birth (in case of)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2018.
- Individual participant dataSharing planned: No
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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.
Thomas BOURLET, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systematic HPV DNA assay in semen and cervicovaginal scrape, Systematic HPV DNA cervicovaginal scrape and systematic HPV Status in newborns in case of pregnancy in people with Human Papillomavirus (HPV) and Medically Assisted Procreation (MAP), run by Centre Hospitalier Universitaire de Saint Etienne at 5 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 24 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Presence of HPV DNA on a swab sampled in the throat of newborns from one or two parents detected positive for HPV in semen and/or cervicovaginal scrape (time frame: at birth). 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 24 Sep 2018.