Prevalence of HPV Transmission During Medically Assisted Procreation Procedures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

915 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-12

Study Completion Date

2016-02-22

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Population of couples candidate for MAP program

MAP = medically assisted procreation

Group Type OTHER

Systematic HPV DNA assay in semen and cervicovaginal scrape

Intervention Type OTHER

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

Systematic HPV DNA cervicovaginal scrape

Intervention Type OTHER

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

systematic HPV Status in newborns in case of pregnancy

Intervention Type OTHER

Interventions

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Systematic HPV DNA assay in semen and cervicovaginal scrape

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

Intervention Type OTHER

Systematic HPV DNA cervicovaginal scrape

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

Intervention Type OTHER

systematic HPV Status in newborns in case of pregnancy

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No