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

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Infertility; Medically Assisted Procreation (MAP); Human Papillomavirus (HPV)

Treatments: Other: systematic HPV Status in newborns in case of pregnancy; Other: Systematic HPV DNA assay in semen and cervicovaginal scrape; Other: Systematic HPV DNA cervicovaginal scrape

Study type: Interventional

Funder types: Other

Identifiers

NCT02524223

1108144

2011-A01337-34 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 915 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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915 participants in 1 patient group

Population of couples candidate for MAP program

Other group

Description:

MAP = medically assisted procreation

Treatment:

Other: Systematic HPV DNA assay in semen and cervicovaginal scrape

Other: systematic HPV Status in newborns in case of pregnancy

Other: Systematic HPV DNA cervicovaginal scrape