Prevalence of HPV Transmission During Medically Assisted Procreation Procedures

Infertility Clinical Trial

— AMPAMAVIR  

Official title:

Prevalence of HPV Transmission During Medically Assisted Procreation Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02524223
• Other study ID #: 1108144
• Secondary ID: 2011-A01337-34
• Status: Completed
• Phase: N/A
• Start date: July 12, 2012
• Est. completion date: February 22, 2016

Study information

• Verified date: September 2018
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 915
• Est. completion date: February 22, 2016
• Est. primary completion date: February 22, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
France	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

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	Genotype of HPV		At the time of enrollment, during MAP procedures and at birth (in case of)
Secondary	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)
Secondary	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)