Prevalence of HPV Transmission During Medically Assisted Procreation Procedures (AMPAMAVIR)

September 21, 2018 updated by: Centre Hospitalier Universitaire de Saint Etienne
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

915

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bondy, France, 93140
        • Hôpital Jean Verdier
      • Bordeaux, France, 33000
        • CHU de Bordeaux
      • Clermont-ferrand, France, 63000
        • CHU de Clermont-Ferrand
      • Paris, France, 75018
        • Hôpital Bichat
      • Saint-etienne, France, 42055
        • CHU de Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Population of couples candidate for MAP program
MAP = medically assisted procreation
Other: Systematic HPV DNA assay in semen and cervicovaginal scrape
Screening of HPV status at the genital level of males enrolled in MAP program.
Other: Systematic HPV DNA cervicovaginal scrape
Screening of HPV status at the genital level of females enrolled in MAP program.
Other: systematic HPV Status in newborns in case of pregnancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
at birth

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
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)
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)
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)
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)
At the time of enrollment, during MAP procedures and at birth (in case of)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Ministry of Health, France

Investigators

  • Principal Investigator: Thomas BOURLET, MD PhD, Centre Hospitalier Universitaire de Saint Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 12, 2012

Primary Completion (ACTUAL)

February 22, 2016

Study Completion (ACTUAL)

February 22, 2016

Study Registration Dates

First Submitted

August 13, 2015

First Submitted That Met QC Criteria

August 13, 2015

First Posted (ESTIMATE)

August 14, 2015

Study Record Updates

Last Update Posted (ACTUAL)

September 24, 2018

Last Update Submitted That Met QC Criteria

September 21, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1108144
  • 2011-A01337-34 (OTHER: AFSSAPS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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