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Sperm Selection for Infertility Treatment (SSA) (SSA)

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ClinicalTrials.gov Identifier: NCT02867111
Recruitment Status : Recruiting
First Posted : August 15, 2016
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Carlos López, Universidad Nacional de Córdoba

Brief 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

Condition or disease Intervention/treatment Phase
Infertility Device: Sperm Selection Assay Other: Attractant Substance Procedure: ICSI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Application of the Sperm Selection Assay in Assisted in Reproductive Technology
Actual Study Start Date : August 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
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
Procedure: ICSI
An in vitro fertilization procedure in which a single sperm is injected directly into an egg
Other Name: Intracytoplasmatic Sperm Injection

Placebo Comparator: 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)
Device: 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.
Other Name: SSA

Procedure: ICSI
An in vitro fertilization procedure in which a single sperm is injected directly into an egg
Other Name: Intracytoplasmatic Sperm Injection

Experimental: 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)
Device: 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.
Other Name: SSA

Other: 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

Procedure: ICSI
An in vitro fertilization procedure in which a single sperm is injected directly into an egg
Other Name: Intracytoplasmatic Sperm Injection




Primary Outcome Measures :
  1. Fertilization rate [ Time Frame: within 24 hs ]
    Fertilization rate= number of fertilized oocyte (oocytes with 2 pronuclei) / Total of injected oocytes in metaphase II


Secondary Outcome Measures :
  1. Embryo quality [ Time Frame: within 48 to 66hs post injection ]
    Grade I: Embryos with blastomeres of same size without fragmentation (degree 1) with clear and homogeneous cytoplasm, II: Embryos with blastomeres of the same size and less than 30% of fragmentation (degree 2 or 3), III: Embryos with blastomeres of different size and 0% of fragmentation (degree 1), IV: Embryos with blastomeres of the same or different sizes with 30 to 50% of fragmentation (degree 4), V: Embryos with more than 50% of fragmentation (degree 5).

  2. Transferable embryo rate [ Time Frame: within 72hs post injection ]
    Transferable embryo rate= Number of embryos in condition to be transferred / Number of oocytes

  3. Pregnancy rate [ Time Frame: within 30 days post injection ]
    pregnancy rate= Number of positive implantation / Total of patients with transferred embryos

  4. Birth rate [ Time Frame: Up to 42 weeks after positive implantation ]
    Birth rate= Number or live birth / Total of positive pregnancy

  5. Implantation yield [ Time Frame: 72 hs post injection ]
    Implantation rate= Number of implanted embryos / Number of transferred embryos

  6. Division rate [ Time Frame: within 24-72 hs post injection ]
    Division rate= divided embryos / oocytes with 2 pronuclei

  7. Fecundation failures in ICSI rate [ Time Frame: Within every cycle of ICSI ]
    ICSI cycles with no oocyte fecundated / ICSI cycles

  8. Blastocyst formation rate [ Time Frame: within 3 to 5 days after injection ]
    number of embryos that reach blastocyst stage / number of total embryos

  9. Abortion rate [ Time Frame: within 3 months post injection ]
    number of abortions / number of pregnancies

  10. multiple embryo rate [ Time Frame: within a month post injection ]
    number of embryos with more than one gestational sac / total of embryos

  11. clinic gestational rate [ Time Frame: within one month after injection ]
    number of cycles when gestational sac is observed / total of cycles

  12. biochemist gestational rate [ Time Frame: within 45 days after injection ]
    number of cycles with positive beta human chorionic gonadotropin without gestational sac / total of cycles

  13. Cycles without transferred embryos rate [ Time Frame: within 2 months after recruitment ]
    number of cycles without transfer / number of cycles with ovaric puncture

  14. Degree Fragmentation [ Time Frame: within 48hs to 66hs post injection ]
    the embryos will be classified according with the size and distribution of cytoplasmic fragments in 5 categories. 1- Without fragments, 2- Up to 10% of fragmentation, 3- Up to 30% of fragmentation, 4- Between 30 to 50% of fragmentation and 5- More than 50% of fragmentation.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Clinical diagnosis for primary and secondary infertility
  • 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.

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.

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): NCT02867111


Contacts
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Contact: Laura C Giojalas, PhD 0054 - 351 - 5353800 ext 30300 lgiojalas@gmail.com
Contact: Maria J. Figueras, PhD 0054 - 9351 - 2209799 ext 30300 mjfigueras@gmail.com

Locations
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Argentina
HALITUS Instituto Médico Recruiting
Buenos Aires, Capital Federal, Argentina, 1414
Contact: Rodolfo A Pasqualini    +54 11 5273 2000    agustin.pasqualini@halitus.com   
Contact: Ines Carretero    +54 11 5273 2000    ines.carretero@halitus.com   
Principal Investigator: Rodolfo A Pasqualini         
Instituto Universitario de Medicina Reproductiva (IUMER) Recruiting
Cordoba, Córdoba, Argentina, X5010AWC
Contact: Ana M Babini, MD    0054 - 351 - 4331050    anababini@gmail.com   
Contact: Maria J. Figueras, PhD    0054 - 9351 - 2209799    mjfigueras@gmail.com   
Principal Investigator: Laura C. Giojalas, PhD         
Sponsors and Collaborators
Universidad Nacional de Córdoba
Investigators
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Principal Investigator: Laura C. Giojalas, PhD National University of Cordoba

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Responsible Party: Carlos López, MD, Universidad Nacional de Córdoba
ClinicalTrials.gov Identifier: NCT02867111     History of Changes
Other Study ID Numbers: IUMER-1
PIDC2014-0016 ( Other Grant/Funding Number: ANPCyT )
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Carlos López, Universidad Nacional de Córdoba:
sperm selection
ICSI
Assisted Reproductive Techniques

Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female