InfertilitySSANCT02867111
Sperm Selection for Infertility Treatment (SSA)
A study testing Sperm Selection Assay, Attractant Substance and ICSI in people with Infertility, run by Universidad Nacional de Córdoba at 2 sites in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Sperm Selection Assay, Attractant Substance and ICSI
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesArgentina
- Study dates
- Aug 2016to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Low complexity assisted reproductive techniques
- In vitro fertilization treatment
- Other medical diagnosis of female infertility besides the inclusion criteria
- Males with oligoasthenoteratozoospermia and oligoasthenozoospermia.
Trial locations and contacts
2 sites in 1 country.
Argentina2 sites, 2 recruiting
- Recruiting
HALITUS Instituto Médico
Buenos Aires, Buenos Aires F.D., 1414
Rodolfo A Pasqualini, +54 11 5273 2000, agustin.pasqualini@halitus.com
Ines Carretero, +54 11 5273 2000, ines.carretero@halitus.com
- Recruiting
Instituto Universitario de Medicina Reproductiva (IUMER)
Córdoba, Córdoba Province, X5010AWC
Ana M Babini, MD, 0054 - 351 - 4331050, anababini@gmail.com
Maria J. Figueras, PhD, 0054 - 9351 - 2209799, mjfigueras@gmail.com
About this study
Official title: Application of the Sperm Selection Assay in Assisted in Reproductive Technology
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
- Conditions
- Infertility
- Being tested
- Sperm Selection Assay, Attractant Substance, ICSI
- Keywords
- sperm selection, ICSI, Assisted Reproductive Techniques
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sperm Selection AssayDevice
Also called SSA
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 SubstanceOther
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
ICSIProcedure or surgery
Also called Intracytoplasmatic Sperm Injection
An in vitro fertilization procedure in which a single sperm is injected directly into an egg
| Study group | Role | What they receive |
|---|---|---|
| ICSI Control | Other | 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 Receives: Procedure: ICSI |
| ICSI + SSA placebo | Placebo comparator | 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) Receives: Device: Sperm Selection Assay; Procedure: ICSI |
| ICSI + SSA Attractant substance | Experimental | 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) Receives: Device: Sperm Selection Assay; Other: Attractant Substance; Procedure: ICSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fertilization rate
Fertilization rate= number of fertilized oocyte (oocytes with 2 pronuclei) / Total of injected oocytes in metaphase II
Measured: within 24 hs
Secondary outcomes (14)
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).
Measured: within 48 to 66hs post injection
Transferable embryo rate
Transferable embryo rate= Number of embryos in condition to be transferred / Number of oocytes
Measured: within 72hs post injection
Pregnancy rate
pregnancy rate= Number of positive implantation / Total of patients with transferred embryos
Measured: within 30 days post injection
Birth rate
Birth rate= Number or live birth / Total of positive pregnancy
Measured: Up to 42 weeks after positive implantation
Implantation yield
Implantation rate= Number of implanted embryos / Number of transferred embryos
Measured: 72 hs post injection
Division rate
Division rate= divided embryos / oocytes with 2 pronuclei
Measured: within 24-72 hs post injection
Fecundation failures in ICSI rate
ICSI cycles with no oocyte fecundated / ICSI cycles
Measured: Within every cycle of ICSI
Blastocyst formation rate
number of embryos that reach blastocyst stage / number of total embryos
Measured: within 3 to 5 days after injection
Abortion rate
number of abortions / number of pregnancies
Measured: within 3 months post injection
multiple embryo rate
number of embryos with more than one gestational sac / total of embryos
Measured: within a month post injection
clinic gestational rate
number of cycles when gestational sac is observed / total of cycles
Measured: within one month after injection
biochemist gestational rate
number of cycles with positive beta human chorionic gonadotropin without gestational sac / total of cycles
Measured: within 45 days after injection
Cycles without transferred embryos rate
number of cycles without transfer / number of cycles with ovaric puncture
Measured: 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.
Measured: within 48hs to 66hs post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos López, Universidad Nacional de Córdoba
- Investigators
- Laura C. Giojalas, PhD, Principal investigator, National University of Cordoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02867111
- Sponsor's protocol ID
- IUMER-1
- Other IDs
- PIDC2014-0016
- Acronym
- SSA
- Status last verified
- Nov 2019
- First submitted
- 1 Aug 2016
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of the Sperm Selection Assay in Assisted in Reproductive Technology
- ClinicalTrials.gov ID
- NCT02867111
- Acronym / sponsor ID
- SSA / IUMER-1
- Conditions
- Infertility
- Keywords
- sperm selection, ICSI, Assisted Reproductive Techniques
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universidad Nacional de CórdobaUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 15 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ICSI Control | Other | Procedure: ICSIIntracytoplasmic 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 + SSA placebo | Placebo comparator | Device: Sperm Selection Assay, Procedure: ICSIIntracytoplasmic 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) |
| ICSI + SSA Attractant substance | Experimental | Device: Sperm Selection Assay, Other: Attractant Substance, Procedure: ICSIIntracytoplasmic 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) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- Low complexity assisted reproductive techniques
- In vitro fertilization treatment
- Other medical diagnosis of female infertility besides the inclusion criteria
- Males with oligoasthenoteratozoospermia and oligoasthenozoospermia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sperm Selection AssayAlso: SSASperm 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. | Device | ICSI + SSA Attractant substance, ICSI + SSA placebo |
| Attractant SubstanceCapacitated 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 | Other | ICSI + SSA Attractant substance |
| ICSIAlso: Intracytoplasmatic Sperm InjectionAn in vitro fertilization procedure in which a single sperm is injected directly into an egg | Procedure or surgery | ICSI + SSA Attractant substance, ICSI + SSA placebo, ICSI Control |
Primary outcome
Fertilization rate
Time frame: within 24 hs
Fertilization rate= number of fertilized oocyte (oocytes with 2 pronuclei) / Total of injected oocytes in metaphase II
14 secondary outcomes
Embryo quality
Time frame: within 48 to 66hs post injection
Transferable embryo rate
Time frame: within 72hs post injection
Pregnancy rate
Time frame: within 30 days post injection
Birth rate
Time frame: Up to 42 weeks after positive implantation
Implantation yield
Time frame: 72 hs post injection
Division rate
Time frame: within 24-72 hs post injection
Fecundation failures in ICSI rate
Time frame: Within every cycle of ICSI
Blastocyst formation rate
Time frame: within 3 to 5 days after injection
Abortion rate
Time frame: within 3 months post injection
multiple embryo rate
Time frame: within a month post injection
clinic gestational rate
Time frame: within one month after injection
biochemist gestational rate
Time frame: within 45 days after injection
Cycles without transferred embryos rate
Time frame: within 2 months after recruitment
Degree Fragmentation
Time frame: within 48hs to 66hs post injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura C. Giojalas, PhD principal investigator
National University of Cordoba
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sperm Selection Assay, Attractant Substance and ICSI in people with Infertility, run by Universidad Nacional de Córdoba at 2 sites in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura C Giojalas, PhD (0054 - 351 - 5353800 ext. 30300, lgiojalas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fertilization rate (time frame: within 24 hs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2019.