Sperm Selection for Infertility Treatment (SSA)
SSA
Application of the Sperm Selection Assay in Assisted in Reproductive Technology
2 other identifiers
interventional
150
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2016
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedFirst Posted
Study publicly available on registry
August 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedNovember 13, 2019
November 1, 2019
4.3 years
August 1, 2016
November 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fertilization rate
Fertilization rate= number of fertilized oocyte (oocytes with 2 pronuclei) / Total of injected oocytes in metaphase II
within 24 hs
Secondary Outcomes (14)
Embryo quality
within 48 to 66hs post injection
Transferable embryo rate
within 72hs post injection
Pregnancy rate
within 30 days post injection
Birth rate
Up to 42 weeks after positive implantation
Implantation yield
72 hs post injection
- +9 more secondary outcomes
Study Arms (3)
ICSI Control
OTHERIntracytoplasmic 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 COMPARATORIntracytoplasmic 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
EXPERIMENTALIntracytoplasmic 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)
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Low complexity assisted reproductive techniques
- In vitro fertilization treatment
- Males with oligoasthenoteratozoospermia and oligoasthenozoospermia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
HALITUS Instituto Médico
Buenos Aires, Buenos Aires F.D., 1414, Argentina
Instituto Universitario de Medicina Reproductiva (IUMER)
Córdoba, Córdoba Province, X5010AWC, Argentina
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laura C. Giojalas, PhD
National University of Cordoba
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
August 1, 2016
First Posted
August 15, 2016
Study Start
August 1, 2016
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
November 13, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share