Overview

This trial is active, not recruiting.

Conditions human papillomavirus (hpv), medically assisted procreation (map), infertility
Treatments systematic hpv dna assay in semen and cervicovaginal scrape, systematic hpv dna cervicovaginal scrape, systematic hpv status in newborns in case of pregnancy
Sponsor Centre Hospitalier Universitaire de Saint Etienne
Collaborator Ministry of Health, France
Start date July 2012
End date April 2016
Trial size 915 participants
Trial identifier NCT02524223, 1108144, 2011-A01337-34

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose screening
Arm
(Other)
MAP = medically assisted procreation
systematic hpv dna assay in semen and cervicovaginal scrape
Screening of HPV status at the genital level of males enrolled in MAP program.
systematic hpv dna cervicovaginal scrape
Screening of HPV status at the genital level of females enrolled in MAP program.
systematic hpv status in newborns in case of pregnancy

Primary Outcomes

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

Secondary Outcomes

Measure
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)

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title Prevalence of HPV Transmission During Medically Assisted Procreation Procedures
Principal investigator Thomas BOURLET, MD PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Centre Hospitalier Universitaire de Saint Etienne.