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Completed

NCT Number: NCT02524223

Prevalence of HPV Transmission During Medically Assisted Procreation Procedures

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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Key information

Conditions

Human Papillomavirus (HPV) Genital Diseases Infertility Medically Assisted Procreation (MAP) Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Jean VERDIER, Bondy, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. 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

  1. 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)

  2. 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)

  3. Genotype of HPV

    Time frame: At the time of enrollment, during MAP procedures and at birth (in case of)

  4. 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)

  5. 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)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Ministry of Health, France

Registry information

Acronym: AMPAMAVIR

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Aug 14, 2015
Registry last updated
Sep 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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