Prevalence of HPV Transmission During Medically Assisted Procreation Procedures

NCT02524223 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 915

Last updated 2018-09-24

No results posted yet for this study

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. 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.

Conditions

  • Human Papillomavirus (HPV)
  • Medically Assisted Procreation (MAP)
  • Infertility

Interventions

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

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV
  • Centre Hospitalier Universitaire de Saint Etienne

    lead OTHER

Principal Investigators

  • Thomas BOURLET, MD PhD · Centre Hospitalier Universitaire de Saint Etienne

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-12
Primary Completion
2016-02-22
Completion
2016-02-22

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02524223 on ClinicalTrials.gov