Pilot Study to Detect Monkey Pox Virus in Sperm: POXSPERM

NCT05629299 | Unknown

• 2 other identifiers: RC31/22/02992022-A01799-34
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Given the current emerging epidemic of the MonkeyPox Virus (MPXV) and its route of transmission, the main objective of this pilot study is to characterize the presence of the MPXV in the semen of patients in the acute phase of infection and following this infection.

Conditions

Monkeypox

Keywords

Monkeypox Virus; semen; testicle; acute phase and follow-up

Outcome Measures

Primary Outcomes (1)

• MPXV genomic DNA

  presence of MPXV DNA in the semen and others body fluids of infected patients in the acute phase and during the follow-up.

  Day 0

Study Arms (1)

Monkey Pox infection

OTHER

Men will give semen, saliva, skin, urine and blood specimens

Biological: Samples

Interventions

Samples BIOLOGICAL

Men will give semen, saliva, skin, urine and blood specimens

Monkey Pox infection

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• in the acute phase of MPXV infection and whose PCR reveals the viral genome in a skin sample or in any other sample.
• able to travel to the laboratory for the samples
• who gave his free and informed consent and having signed the consent
• Patient affiliated to a social security scheme or equivalent

You may not qualify if:

• Patient who has previously consulted for male infertility or who has previously performed an abnormal semen test (WHO standard)
• Patient with ejaculation disorder or unable to collect semen or with abnormal semen volume (\<1.5 mL).
• Patient who presents serious clinical signs that do not allow him to travel to the investigation center.
• Patient under a protection regime (including guardianship, curatorship or safeguard of justice)

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Mpox, Monkeypox

Interventions

Sampling Studies

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Primate Diseases; Animal Diseases; Rodent Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Manon CARLES, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manon CARLES, MD

CONTACT

05 67 77 10 07; carles.man@chu-toulouse.fr

Study Design

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

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 29, 2022
• Study Start: November 1, 2022
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)