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Pilot Study to Detect Monkey Pox Virus in Sperm: POXSPERM

T

Toulouse University Hospital

Status

Not yet enrolling

Conditions

Monkeypox

Treatments

Biological: Samples

Study type

Interventional

Funder types

Other

Identifiers

NCT05629299
RC31/22/0299
2022-A01799-34 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

Male

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Monkey Pox infection
Other group
Description:
Men will give semen, saliva, skin, urine and blood specimens
Treatment:
Biological: Samples

Trial contacts and locations

1

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Central trial contact

Manon CARLES, MD

Data sourced from clinicaltrials.gov

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