Sperm Selection for Infertility Treatment (SSA)

Universidad Nacional de Córdoba

Status: Unknown

Conditions: Infertility

Treatments: Device: Sperm Selection Assay; Procedure: ICSI; Other: Attractant Substance

Study type: Interventional

Funder types: Other

Identifiers

NCT02867111

PIDC2014-0016 (Other Grant/Funding Number)

IUMER-1

Details and patient eligibility

About

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

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups, including a placebo group

ICSI Control

Other group

Description:

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

Treatment:

Procedure: ICSI

ICSI + SSA placebo

Placebo Comparator group

Description:

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)

Treatment:

Procedure: ICSI

Device: Sperm Selection Assay

ICSI + SSA Attractant substance

Experimental group

Description:

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)

Treatment:

Other: Attractant Substance

Procedure: ICSI

Device: Sperm Selection Assay