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Prevalence of HPV Transmission During Medically Assisted Procreation Procedures (AMPAMAVIR)

Primary Purpose

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

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Systematic HPV DNA assay in semen and cervicovaginal scrape

Systematic HPV DNA cervicovaginal scrape

systematic HPV Status in newborns in case of pregnancy

About this trial

This is an interventional screening trial for Human Papillomavirus (HPV) focused on measuring medically assisted procreation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

Hôpital Jean VERDIER
CHU de BORDEAUX
CHU de CLERMONT-FERRAND
Hôpital BICHAT
CHU de SAINT-ETIENNE

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Population of couples candidate for MAP program

Arm Description

MAP = medically assisted procreation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Presence of HPV DNA in seminal fractions: seminal plasma, sperm cells dedicated to MAP

Quantitative et qualitative parameters of spermogram analysis: volume of the ejaculate, number, mobility and morphology of sperm cells according to WHO criteria)

Genotype of HPV

Presence of HPV DNA in ovocytes samples and in embryo culture media

Quantitative and qualitative parameters of MAP procedures: fertilization rate, number of ovocytes, number of embryos…

Full Information

NCT ID

NCT02524223

First Posted

August 13, 2015

Last Updated

September 21, 2018

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Ministry of Health, France

1. Study Identification

Unique Protocol Identification Number

NCT02524223

Brief Title

Prevalence of HPV Transmission During Medically Assisted Procreation Procedures

Acronym

AMPAMAVIR

Official Title

Prevalence of HPV Transmission During Medically Assisted Procreation Procedures

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

July 12, 2012 (Actual)

Primary Completion Date

February 22, 2016 (Actual)

Study Completion Date

February 22, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Ministry of Health, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

medically assisted procreation

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

915 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Population of couples candidate for MAP program

Arm Type

Other

Arm Description

MAP = medically assisted procreation

Intervention Type

Other

Intervention Name(s)

Systematic HPV DNA assay in semen and cervicovaginal scrape

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Systematic HPV DNA cervicovaginal scrape

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

systematic HPV Status in newborns in case of pregnancy

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Presence of HPV DNA in seminal fractions: seminal plasma, sperm cells dedicated to MAP

Time Frame