Clinical trial NCT02524223: Prevalence of HPV Transmission During Medically Assisted Procreation Procedures
Official title: Prevalence of HPV Transmission During Medically Assisted Procreation Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papillomavirus (HPV)
Medically Assisted Procreation (MAP)
Infertility
Keywords: medically assisted procreation
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2015-08-14
Enrollment: 915
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


Eligibility criteria: 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)

Primary outcomes:
measure: 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
timeFrame: at birth
Secondary outcomes:
measure: Presence of HPV DNA in seminal fractions: seminal plasma, sperm cells dedicated to MAP
timeFrame: At the time of enrollment, during MAP procedures and at birth (in case of)
measure: Quantitative et qualitative parameters of spermogram analysis: volume of the ejaculate, number, mobility and morphology of sperm cells according to WHO criteria)
timeFrame: At the time of enrollment, during MAP procedures and at birth (in case of)
measure: Genotype of HPV
timeFrame: At the time of enrollment, during MAP procedures and at birth (in case of)
measure: Presence of HPV DNA in ovocytes samples and in embryo culture media
timeFrame: At the time of enrollment, during MAP procedures and at birth (in case of)
measure: Quantitative and qualitative parameters of MAP procedures: fertilization rate, number of ovocytes, number of embryos…
timeFrame: At the time of enrollment, during MAP procedures and at birth (in case of)
Other outcomes:
Locations:
city: Bondy
country: France
facility: Hôpital Jean VERDIER
city: Bordeaux
country: France
facility: CHU de BORDEAUX
city: Clermont-ferrand
country: France
facility: CHU de CLERMONT-FERRAND
city: Paris
country: France
facility: Hôpital BICHAT
city: Saint-etienne
country: France
facility: CHU de SAINT-ETIENNE
Study officials:
affiliation: Centre Hospitalier Universitaire de Saint Etienne
name: Thomas BOURLET, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: