Sperm Selection for Infertility Treatment (SSA)

Last updated: November 11, 2019
Sponsor: Universidad Nacional de Córdoba
Overall Status: Active - Recruiting

Phase

N/A

Condition

Infertility

Treatment

N/A

Clinical Study ID

NCT02867111
IUMER-1
PIDC2014-0016
  • Ages 18-50
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Infertility is considered a disease by the World Health Organization and it is increasing worldwide affecting more than 70 million couples. About 50% of the cases are due to male inability to fertilize the oocyte. In the last 40 years, several techniques, known as Assisted Reproduction Technology (ART) have been developed to treat infertility, but the efficiency is still relatively low (around 30%) whereas the remaining 70% attempts again several times, an expensive and emotionally moving treatment. Over 4million of infertility treatments are practiced around the world per year and a 50% increment is expected over the next 6years. Even though ART allows the birth of babies that would be impossible under natural circumstances, it is still necessary to improve the procedures in order to increase treatment efficiency. The success of ART depends, to some extent, on sperm quality. Indeed, the relevance of spermatozoa quality is notorious even beyond fertilization, extending to embryo development and implantation. In this context, it has been developed a new technology that allows the selection of those spermatozoa at their best functional state (Sperm Selection Assay, SSA; Patent approved for USA and Europe, pending for Japan and Argentina). This method is based on the attraction of spermatozoa ready to fertilize the egg, towards a physiological attractant molecule. The SSA may be applied to improve diagnosis and infertility treatment. The investigators hypothesis states that the use of the SSA will improve the number of good-quality embryos which are the ones to be transferred by intracytoplasmic sperm injection (ICSI), providing a healthy embryo development. The protocol involves three experimental groups where the SSA will be used or not, before performing the ICSI: 1)SSA containing the sperm attractant molecule, 2)SSA without the attractant molecule, and 3)without SSA. The patient inclusion criteria involve female factors associated to tubal obstruction and/or endometriosis and male factors associated to sperm disability. Several outcome parameters will be determined, the percentage of fertilization, embryo quality, rate of pregnancy and rate of birth. The study will be carried out in the Universitarian Institute of Reproductive Medicine (IUMER) which has been recently established in a public hospital depending on the National University of Córdoba, offering free high complexity infertility treatment to patients without health insurance or economic support

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinical diagnosis for primary and secondary infertility

  • Healthy females or females with tubal obstruction (uni or bilateral) and/orendometriosis.

  • 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 orasthenoteratozoospermia.

Exclusion

Exclusion Criteria:

  • Low complexity assisted reproductive techniques

  • In vitro fertilization treatment

  • Other medical diagnosis of female infertility besides the inclusion criteria

  • Males with oligoasthenoteratozoospermia and oligoasthenozoospermia.

Study Design

Total Participants: 150
Study Start date:
August 01, 2016
Estimated Completion Date:
December 31, 2020

Connect with a study center

  • HALITUS Instituto Médico

    Buenos Aires, Capital Federal 1414
    Argentina

    Active - Recruiting

  • Instituto Universitario de Medicina Reproductiva (IUMER)

    Cordoba, Córdoba X5010AWC
    Argentina

    Active - Recruiting

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