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Pilot Study to Detect Monkey Pox Virus in Sperm: POXSPERM

Pilot Study to Detect Monkey Pox Virus in Sperm: POXSPERM

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05629299
Acronym
POXSPERM
Enrollment
30
Registered
2022-11-29
Start date
2022-11-30
Completion date
2024-11-30
Last updated
2022-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Monkeypox

Keywords

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

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.

Interventions

BIOLOGICALSamples

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

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
MPXV genomic DNADay 0presence of MPXV DNA in the semen and others body fluids of infected patients in the acute phase and during the follow-up.

Countries

France

Contacts

Primary ContactManon CARLES, MD
carles.man@chu-toulouse.fr05 67 77 10 07

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026