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

• ClinicalTrials.gov Identifier: NCT05629299
• Recruitment Status: Not yet recruiting
• First Posted: November 29, 2022
• Last Update Posted: November 29, 2022
• Sponsor: University Hospital, Toulouse
• Information provided by (Responsible Party): University Hospital, Toulouse

Tracking Information

• First Submitted Date: November 15, 2022
• First Posted Date: November 29, 2022
• Last Update Posted Date: November 29, 2022
• Estimated Study Start Date: November 2022
• Estimated Primary Completion Date: November 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 28, 2022)

MPXV genomic DNA [ Time Frame: Day 0 ]

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pilot Study to Detect Monkey Pox Virus in Sperm: POXSPERM
• Official Title: Pilot Study to Detect Monkey Pox Virus in Sperm: POXSPERM
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Monkeypox

Intervention

Biological: Samples

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

Study Arms

Monkey Pox infection

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

Intervention: Biological: Samples

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: November 28, 2022): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 2024
• Estimated Primary Completion Date: November 2024 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Manon CARLES, MD; 05 67 77 10 07 ext +33; carles.man@chu-toulouse.fr

• Listed Location Countries: France

Administrative Information

• NCT Number: NCT05629299
• Other Study ID Numbers: RC31/22/0299; 2022-A01799-34 ( Other Identifier: ID-RCB )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University Hospital, Toulouse
• Original Responsible Party: Same as current
• Current Study Sponsor: University Hospital, Toulouse
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Manon CARLES, MD; University Hospital, Toulouse

• PRS Account: University Hospital, Toulouse
• Verification Date: November 2022