Pilot Study to Detect Monkey Pox Virus in Sperm: POXSPERM (POXSPERM)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Monkeypox
• Intervention / Treatment: Biological: Samples

Detailed Description

Since May 2022, a total of 16 000 new cases of Monkey Pox Virus infection has been reported in 76 non-endemic countries. The WHO has declared this epidemic as a public health emergency. Principal routes of transmission are direct skin or mucosa contact or aerosol transmission. The current epidemic mainly affects men having sexual relations with others men and men reporting having recent sexual relations with new or multiple partners. We may wonder if there is a risk of transmission during an intercourse. Moreover, Monkey pox virus infection in human testicle has not been studied yet. Among viruses that infect human semen, some viruses can persist for several months or even years in the semen of cured men. In this context, we propose a research project about the pathophysiology of MPXV in the male genital tract by a clinical approach. Men with a diagnosis of MPXV infection confirmed by a positive PCR and who agreed to be included as volunteer will go to CECOS at Paule de Viguier Hospital, Purpan. Each patient will take a semen and urine sample, have a blood sample and a saliva sample, and a skin sample in case of a lesion; the earliest after the confirmation of the diagnosis of the infection (before the 7th day, the days will be noted) then on Day 15, Day 30, Day 60, Day 90 and Day 180.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Manon CARLES, MD; Phone Number: +33 05 67 77 10 07; Email: carles.man@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France
    • CHU Toulouse
    • Contact: Manon CARLES, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Monkey Pox infection; Men will give semen, saliva, skin, urine and blood specimens	Biological: Samples; Men will give semen, saliva, skin, urine and blood specimens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Manon CARLES, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): November 1, 2024
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: November 28, 2022
• First Posted (Actual): November 29, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: semen; Monkeypox Virus; testicle; acute phase and follow-up
• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Poxviridae Infections; Monkeypox
• Other Study ID Numbers: RC31/22/0299; 2022-A01799-34 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No