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

Primary Purpose

Monkeypox

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Samples
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Monkeypox focused on measuring Monkeypox Virus, semen, testicle, acute phase and follow-up

Eligibility Criteria

18 Years - 50 Years (Adult)MaleDoes not accept 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)

Sites / Locations

  • CHU Toulouse

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Monkey Pox infection

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 15, 2022
Last Updated
November 28, 2022
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT05629299
Brief Title
Pilot Study to Detect Monkey Pox Virus in Sperm: POXSPERM
Acronym
POXSPERM
Official Title
Pilot Study to Detect Monkey Pox Virus in Sperm: POXSPERM
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2022 (Anticipated)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Monkeypox
Keywords
Monkeypox Virus, semen, testicle, acute phase and follow-up

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Monkey Pox infection
Arm Type
Other
Arm Description
Men will give semen, saliva, skin, urine and blood specimens
Intervention Type
Biological
Intervention Name(s)
Samples
Intervention Description
Men will give semen, saliva, skin, urine and blood specimens
Primary Outcome Measure Information:
Title
MPXV genomic DNA
Description
presence of MPXV DNA in the semen and others body fluids of infected patients in the acute phase and during the follow-up.
Time Frame
Day 0

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manon CARLES, MD
Phone
05 67 77 10 07
Ext
+33
Email
carles.man@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manon CARLES, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Toulouse
City
Toulouse
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manon CARLES, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pilot Study to Detect Monkey Pox Virus in Sperm: POXSPERM

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