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Completed

NCT Number: NCT02874456

Pilot Study to Detect Zika Virus in Sperm

The purpose of this study is to seek the presence of ZIKV in semen, to determine its localization and to assess the efficiency of spermatozoa processing methods to obtain virus free spermatozoa.

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Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Pointe-à-Pitre, 97159, Guadeloupe

About this study

Since the end of 2015 an epidemic of ZIKA virus (ZIKV) infections is occurring in the Antilles-Guyana departments and focuses our attention on ZIKV and the risk of transmission during assisted reproductive technologies (ART). The importance of this epidemic and the presence in mainland of its mosquito vector (Aedes albopictus) point out the risk of a geographic extension of this infection. In this context the use of Medically Assisted Procreation leads to several questions when patients are infected. The question surges for patients (women and men) who live in epidemic areas but also for people who return from these regions and many other countries within the epidemic area (principally south and central America) and who need ART. Information about localization of ZIKV in the genital tract or shedding is poorly documented. Only two case reports detected ZIKV RNA in the semen and a sexual transmission was described. However, there is no data on the duration of the presence of ZIKV in semen and on localization of ZIKV in semen compartments (cells, seminal plasma, spermatozoa). The purpose of this study is to seek the presence of ZIKV in semen, to determine its localization and to assess the efficiency of spermatozoa processing methods to obtain virus free spermatozoa.

This is a prospective study involving 15 patients, with acute ZIKV infection and a positive RNA detection in blood or/and urines (Institut Pasteur, Pointe-à-Pitre). Men will give semen, urine and blood specimens 7 days after the beginning of clinical signs and 11, 20, 30, 60 and 90 days after. ZIKV RNA being diagnosed with blood and/or urine sample positive for ZIKV RNA. ZIKV RNA will be detected in seminal plasma, native semen cells and processed spermatozoa. Semen sampling and processing will be performed within the ART laboratory of the hospital of Pointe-à-Pitre (Guadeloupe) and research of ZIKV RNA in the laboratory of Virology of Toulouse University Hospital. This study will identify the presence or absence of ZIKV seminal shedding and in case of shedding, verify the efficiency of semen processing to obtain virus free spermatozoa.

These results are important to understand the physiopathology of ZIKV infection and will help to define the management and viral safety procedures during Medically assisted Procreation in the context of ZIKV epidemic.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • infection by ZIKA virus in early stage

Exclusion criteria

  • non infected male,
  • erection problems

Treatment and study plan

virus detection

Other

Men will give semen, urine and blood specimens 7 days after the beginning of clinical signs and 11, 20, 30, 60 and 90 days after. ZIKV RNA will be detected in seminal plasma, native semen cells and processed spermatozoa.

Primary outcomes

  1. presence of Zika virus on RNA by polymerase chain reaction

    Time frame: 6 months

    Presence or absence of ZIKV seminal shedding and in case of shedding, verify the efficiency of semen processing to obtain virus free spermatozoa.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

  • Centre Hospitalier Universitaire de la Guadeloupe
  • Institut Pasteur

Registry information

Acronym: ZIKSPERM

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 22, 2016
Registry last updated
Nov 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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