Prevalence of HPV Transmission During Medically Assisted Procreation Procedures

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02524223

Acronym

AMPAMAVIR

Enrollment

915

Registered

2015-08-14

Start date

2012-07-12

Completion date

2016-02-22

Last updated

2018-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

medically assisted procreation

Brief 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.

Interventions

OTHERSystematic HPV DNA assay in semen and cervicovaginal scrape

Screening of HPV status at the genital level of males enrolled in MAP program.

OTHERSystematic HPV DNA cervicovaginal scrape

Screening of HPV status at the genital level of females enrolled in MAP program.

OTHERsystematic HPV Status in newborns in case of pregnancy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026