Prevalence of HPV Transmission During Medically Assisted Procreation Procedures

Centre Hospitalier Universitaire de Saint Etienne915 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

915

Conditions

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

Interventions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (5)

Hôpital Jean VERDIER

Bondy, France

CHU de BORDEAUX

Bordeaux, France

CHU de CLERMONT-FERRAND

Clermont-Ferrand, France

Hôpital BICHAT

Paris, France

CHU de SAINT-ETIENNE

Saint-Etienne, France

Outcomes

Primary Outcomes

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