Prevalence of HPV Transmission During Medically Assisted Procreation Procedures

Not Applicable

Completed

• Conditions: Human Papillomavirus (HPV); Medically Assisted Procreation (MAP); Infertility
• Interventions: 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

• Registration Number: NCT02524223
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-12
• Study First Submitted: 2015-08-13
• Study First Submitted QC: 2015-08-13
• Study First Posted: 2015-08-14
• Primary Completion: 2016-02-22
• Study Completion: 2016-02-22
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-21
• Last Update Posted: 2018-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 915

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Population of couples candidate for MAP program	Systematic HPV DNA cervicovaginal scrape	MAP = medically assisted procreation
Population of couples candidate for MAP program	systematic HPV Status in newborns in case of pregnancy	MAP = medically assisted procreation
Population of couples candidate for MAP program	Systematic HPV DNA assay in semen and cervicovaginal scrape	MAP = medically assisted procreation

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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)
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)

Trial Locations

Locations (5)

CHU de BORDEAUX; 🇫🇷 Bordeaux, France

Hôpital Jean VERDIER; 🇫🇷 Bondy, France

CHU de CLERMONT-FERRAND; 🇫🇷 Clermont-ferrand, France

Hôpital BICHAT; 🇫🇷 Paris, France

CHU de SAINT-ETIENNE; 🇫🇷 Saint-etienne, France