Clinical trial NCT02867111: Sperm Selection for Infertility Treatment (SSA)
Official title: Application of the Sperm Selection Assay in Assisted in Reproductive Technology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Keywords: sperm selection
ICSI
Assisted Reproductive Techniques
Lead sponsor: Universidad Nacional de Córdoba
Sponsor class: OTHER
First posted: 2016-08-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Fertilization rate
timeFrame: within 24 hs
Secondary outcomes:
measure: Embryo quality
timeFrame: within 48 to 66hs post injection
measure: Transferable embryo rate
timeFrame: within 72hs post injection
measure: Pregnancy rate
timeFrame: within 30 days post injection
measure: Birth rate
timeFrame: Up to 42 weeks after positive implantation
measure: Implantation yield
timeFrame: 72 hs post injection
measure: Division rate
timeFrame: within 24-72 hs post injection
measure: Fecundation failures in ICSI rate
timeFrame: Within every cycle of ICSI
measure: Blastocyst formation rate
timeFrame: within 3 to 5 days after injection
measure: Abortion rate
timeFrame: within 3 months post injection
measure: multiple embryo rate
timeFrame: within a month post injection
measure: clinic gestational rate
timeFrame: within one month after injection
measure: biochemist gestational rate
timeFrame: within 45 days after injection
measure: Cycles without transferred embryos rate
timeFrame: within 2 months after recruitment
measure: Degree Fragmentation
timeFrame: within 48hs to 66hs post injection
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: HALITUS Instituto Médico
state: Capital Federal
city: Cordoba
country: Argentina
facility: Instituto Universitario de Medicina Reproductiva (IUMER)
state: Córdoba
Study officials:
affiliation: National University of Cordoba
name: Laura C. Giojalas, PhD
role: PRINCIPAL_INVESTIGATOR
References: