We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05629299
Recruitment Status : Not yet recruiting
First Posted : November 29, 2022
Last Update Posted : November 29, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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.

Condition or disease Intervention/treatment Phase
Monkeypox Biological: Samples Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pilot Study to Detect Monkey Pox Virus in Sperm: POXSPERM
Estimated Study Start Date : November 2022
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Monkey Pox infection
Men will give semen, saliva, skin, urine and blood specimens
Biological: Samples
Men will give semen, saliva, skin, urine and blood specimens




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05629299


Contacts
Layout table for location contacts
Contact: Manon CARLES, MD 05 67 77 10 07 ext +33 carles.man@chu-toulouse.fr

Locations
Layout table for location information
France
CHU Toulouse
Toulouse, France
Contact: Manon CARLES, MD         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Layout table for investigator information
Principal Investigator: Manon CARLES, MD University Hospital, Toulouse
Layout table for additonal information
Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT05629299    
Other Study ID Numbers: RC31/22/0299
2022-A01799-34 ( Other Identifier: ID-RCB )
First Posted: November 29, 2022    Key Record Dates
Last Update Posted: November 29, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
Monkeypox Virus
semen
testicle
acute phase and follow-up
Additional relevant MeSH terms:
Layout table for MeSH terms
Monkeypox
Poxviridae Infections
DNA Virus Infections
Virus Diseases
Infections