Prevalence of HPV Transmission During Medically Assisted Procreation Procedures

NCT02524223 | Completed

• 2 other identifiers: 11081442011-A01337-34
• Study Type: interventional
• Target: 915
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Keywords

medically assisted procreation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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)

• 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)

• 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)

Study Arms (1)

Population of couples candidate for MAP program

OTHER

MAP = medically assisted procreation

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

Interventions

Systematic HPV DNA assay in semen and cervicovaginal scrape OTHER

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

Population of couples candidate for MAP program

Systematic HPV DNA cervicovaginal scrape OTHER

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

Population of couples candidate for MAP program

systematic HPV Status in newborns in case of pregnancy OTHER

Population of couples candidate for MAP program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Severe oligospermia in male partner (\<500 000 sperm cells)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Ministry of Health, France: collaborator

Study Sites (5)

Hôpital Jean VERDIER

Bondy, 93140, France

Location

CHU de BORDEAUX

Bordeaux, 33000, France

Location

CHU de CLERMONT-FERRAND

Clermont-Ferrand, 63000, France

Location

Hôpital BICHAT

Paris, 75018, France

Location

CHU de SAINT-ETIENNE

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Infertility

Interventions

Seeds

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Thomas BOURLET, MD PhD

  Centre Hospitalier Universitaire de Saint Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2015
• First Posted: August 14, 2015
• Study Start: July 12, 2012
• Primary Completion: February 22, 2016
• Study Completion: February 22, 2016
• Last Updated: September 24, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)