Pilot Study to Detect Monkey Pox Virus in Sperm: POXSPERM

Monkeypox Clinical Trial

— POXSPERM  

Official title:

Pilot Study to Detect Monkey Pox Virus in Sperm: POXSPERM

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05629299
• Other study ID #: RC31/22/0299
• Secondary ID: 2022-A01799-34
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2022
• Est. completion date: November 2024

Study information

• Verified date: November 2022
• Source: University Hospital, Toulouse
• Contact: Manon CARLES, MD
• Phone: 05 67 77 10 07
• Email: carles.man[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Monkeypox

Intervention

Biological:
• Samples
Men will give semen, saliva, skin, urine and blood specimens

Locations

Country	Name	City	State
France	CHU Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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