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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Monkeypox | Biological: Samples | Not Applicable |
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 |
Arm | Intervention/treatment |
---|---|
Monkey Pox infection
Men will give semen, saliva, skin, urine and blood specimens
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Biological: Samples
Men will give semen, saliva, skin, urine and blood specimens |
- 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.
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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Male |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | No |
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)
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
Contact: Manon CARLES, MD | 05 67 77 10 07 ext +33 | carles.man@chu-toulouse.fr |
France | |
CHU Toulouse | |
Toulouse, France | |
Contact: Manon CARLES, MD |
Principal Investigator: | Manon CARLES, MD | University Hospital, Toulouse |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Monkeypox Virus semen testicle acute phase and follow-up |
Mpox (monkeypox) Poxviridae Infections DNA Virus Infections Virus Diseases Infections |