An interventional study of Sperm Selection Assay and Attractant Substance in Infertility, sponsored by Universidad Nacional de Córdoba. Status unknown at 2 sites in Argentina. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-13.
Sponsored by Universidad Nacional de Córdoba · Not applicable, Interventional, and Treatment
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
2,541 studies on the registry are indexed under Infertility; 405 are open to participants now.
This study's planned enrollment of 150 is above the median of 120 across 1,722 interventional studies indexed under Infertility.
Browse Infertility studies →Universidad Nacional de Córdoba is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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
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 · Procedure: ICSI
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 · Other: Attractant Substance · Procedure: ICSI
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.
Also known as: SSA
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
An in vitro fertilization procedure in which a single sperm is injected directly into an egg
Also known as: Intracytoplasmatic Sperm Injection
Fertilization rate
Fertilization rate= number of fertilized oocyte (oocytes with 2 pronuclei) / Total of injected oocytes in metaphase II
Time frame: within 24 hs
Embryo quality
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).
Time frame: within 48 to 66hs post injection
Transferable embryo rate
Transferable embryo rate= Number of embryos in condition to be transferred / Number of oocytes
Time frame: within 72hs post injection
Pregnancy rate
pregnancy rate= Number of positive implantation / Total of patients with transferred embryos
Time frame: within 30 days post injection
Birth rate
Birth rate= Number or live birth / Total of positive pregnancy
Time frame: Up to 42 weeks after positive implantation
Implantation yield
Implantation rate= Number of implanted embryos / Number of transferred embryos
Time frame: 72 hs post injection
Division rate
Division rate= divided embryos / oocytes with 2 pronuclei
Time frame: within 24-72 hs post injection
Fecundation failures in ICSI rate
ICSI cycles with no oocyte fecundated / ICSI cycles
Time frame: Within every cycle of ICSI
Blastocyst formation rate
number of embryos that reach blastocyst stage / number of total embryos
Time frame: within 3 to 5 days after injection
Abortion rate
number of abortions / number of pregnancies
Time frame: within 3 months post injection
multiple embryo rate
number of embryos with more than one gestational sac / total of embryos
Time frame: within a month post injection
clinic gestational rate
number of cycles when gestational sac is observed / total of cycles
Time frame: within one month after injection
biochemist gestational rate
number of cycles with positive beta human chorionic gonadotropin without gestational sac / total of cycles
Time frame: within 45 days after injection
Cycles without transferred embryos rate
number of cycles without transfer / number of cycles with ovaric puncture
Time frame: within 2 months after recruitment
Degree Fragmentation
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.
Time frame: within 48hs to 66hs post injection
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2016 (actual). Primary completion is estimated for Dec 2020, 52 months after the start.
Of 498 non-industry interventional studies with no phase under Infertility, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 52 months is above that.
Counting every sponsor, half of 541 studies reached it within 23 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Universidad Nacional de Córdoba