Pilot Study to Detect Monkey Pox Virus in Sperm: POXSPERM

NCT ID: NCT05629299

Last Updated: 2022-11-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-30
• Study Completion Date: 2024-11-30

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.

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.

Conditions

Monkeypox

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Monkey Pox infection

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

Group Type: OTHER

Samples

Intervention Type: BIOLOGICAL

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

Interventions

Samples

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manon CARLES, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

CHU Toulouse

Toulouse, , France

Countries

France

Central Contacts

Manon CARLES, MD

Role: CONTACT

carles.man@chu-toulouse.fr

05 67 77 10 07 ext. +33

Facility Contacts

Manon CARLES, MD

Role: primary

Other Identifiers

2022-A01799-34

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/22/0299

Identifier Type: -

Identifier Source: org_study_id