Prevalence of HPV Transmission During Medically Assisted Procreation Procedures

NCT02524223 — Not applicable, Completed, 915 participants, Centre Hospitalier Universitaire de Saint Etienne

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Registry	NCT02524223, acronym AMPAMAVIR
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, screening
Enrollment	915 (Actual)
Sponsor	Centre Hospitalier Universitaire de Saint Etienne (Other); collaborators: Ministry of Health, France
Conditions	Human Papillomavirus (HPV), Medically Assisted Procreation (MAP), Infertility
Interventions	Systematic HPV DNA assay in semen and cervicovaginal scrape, Systematic HPV DNA cervicovaginal scrape, systematic HPV Status in newborns in case of pregnancy (Other)
Dates	start 2012-07-12, primary completion 2016-02-22, completion 2016-02-22, first posted 2015-08-14, last updated 2018-09-24
Locations	5 sites in France

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Population of couples candidate for MAP program	Other	Other: Systematic HPV DNA assay in semen and cervicovaginal scrape; Other: Systematic HPV DNA cervicovaginal scrape; Other: systematic HPV Status in newborns in case of pregnancy	MAP = medically assisted procreation

Systematic HPV DNA assay in semen and cervicovaginal scrape (Other): Screening of HPV status at the genital level of males enrolled in MAP program.
Systematic HPV DNA cervicovaginal scrape (Other): Screening of HPV status at the genital level of females enrolled in MAP program.
systematic HPV Status in newborns in case of pregnancy (Other)

+Outcome measures

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 [at birth]

Secondary outcomes

Presence of HPV DNA in seminal fractions: seminal plasma, sperm cells dedicated to MAP [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) [At the time of enrollment, during MAP procedures and at birth (in case of)]
Genotype of HPV [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 [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… [At the time of enrollment, during MAP procedures and at birth (in case of)]

+Eligibility

Sex: All, ages: 18 Years to any

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)

Facility	City	Country
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

+Investigators

Thomas BOURLET, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne