Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2016-08-31
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ICSI Control
Intracytoplasmic sperm injection (ICSI), an in vitro fertilization procedure in which a single sperm is injected directly into an egg, with no intervention of the Sperm Selection Assay
ICSI
An in vitro fertilization procedure in which a single sperm is injected directly into an egg
ICSI + SSA placebo
Intracytoplasmic sperm injection (ICSI), an in vitro fertilization procedure in which a single sperm is injected directly into an egg, with intervention of the Sperm Selection Assay with control solution (culture medium)
Sperm Selection Assay
Sperm Selection Assay (SSA) that allow the investigators to select functional spermatozoa, which are capacitated, with intact DNA, reduced oxidative stress and with good viability and motility, on the basis of sperm chemotaxis towards a physiological attractant molecule.
ICSI
An in vitro fertilization procedure in which a single sperm is injected directly into an egg
ICSI + SSA Attractant substance
Intracytoplasmic sperm injection (ICSI), an in vitro fertilization procedure in which a single sperm is injected directly into an egg, with intervention of the Sperm Selection Assay with attractant solution (attractant diluted in culture medium at 10 pM)
Sperm Selection Assay
Sperm Selection Assay (SSA) that allow the investigators to select functional spermatozoa, which are capacitated, with intact DNA, reduced oxidative stress and with good viability and motility, on the basis of sperm chemotaxis towards a physiological attractant molecule.
Attractant Substance
Capacitated spermatozoa may be oriented by following an increasing concentration gradient of an attractant molecule, a phenomenon called sperm chemotaxis. This is a guidance mechanism observed in vitro, which may transport and retain spermatozoa at the fertilization site. Though several molecules have been suggested to attract human spermatozoa, in the context of gamete interaction prior to fertilization, progesterone has biological importance for several reasons. After ovulation, this hormone is secreted by the cumulus cells that surround the oocyte, diffusing to form a molecular gradient toward the periphery of the cumulus and beyond. Notably, a gradient of very low concentrations (picomolar) of progesterone is sufficient to chemically attract capacitated human spermatozoa
ICSI
An in vitro fertilization procedure in which a single sperm is injected directly into an egg
Interventions
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Sperm Selection Assay
Sperm Selection Assay (SSA) that allow the investigators to select functional spermatozoa, which are capacitated, with intact DNA, reduced oxidative stress and with good viability and motility, on the basis of sperm chemotaxis towards a physiological attractant molecule.
Attractant Substance
Capacitated spermatozoa may be oriented by following an increasing concentration gradient of an attractant molecule, a phenomenon called sperm chemotaxis. This is a guidance mechanism observed in vitro, which may transport and retain spermatozoa at the fertilization site. Though several molecules have been suggested to attract human spermatozoa, in the context of gamete interaction prior to fertilization, progesterone has biological importance for several reasons. After ovulation, this hormone is secreted by the cumulus cells that surround the oocyte, diffusing to form a molecular gradient toward the periphery of the cumulus and beyond. Notably, a gradient of very low concentrations (picomolar) of progesterone is sufficient to chemically attract capacitated human spermatozoa
ICSI
An in vitro fertilization procedure in which a single sperm is injected directly into an egg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Healthy females or females with tubal obstruction (uni or bilateral) and/or endometriosis.
* Clinical diagnosis for unexplained infertility.
* Females between 18 and 40 years old.
* Healthy males between 18 and 50 years old.
* Males with oligozoospermia, teratozoospermia, asthenozoospermia or asthenoteratozoospermia.
* Males with oligoasthenoteratozoospermia and oligoasthenozoospermia.
Exclusion Criteria
* In vitro fertilization treatment
18 Years
50 Years
ALL
Yes
Sponsors
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Universidad Nacional de Córdoba
OTHER
Responsible Party
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Carlos López
MD
Principal Investigators
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Laura C. Giojalas, PhD
Role: PRINCIPAL_INVESTIGATOR
National University of Cordoba
Locations
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HALITUS Instituto Médico
Buenos Aires, Buenos Aires F.D., Argentina
Instituto Universitario de Medicina Reproductiva (IUMER)
Córdoba, Córdoba Province, Argentina
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PIDC2014-0016
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
IUMER-1
Identifier Type: -
Identifier Source: org_study_id
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