Sperm Selection for Infertility Treatment (SSA)

NCT ID: NCT02867111

Last Updated: 2019-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infertility

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ICSI Control

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

Group Type OTHER

ICSI

Intervention Type PROCEDURE

An in vitro fertilization procedure in which a single sperm is injected directly into an egg

ICSI + SSA placebo

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)

Group Type PLACEBO_COMPARATOR

Sperm Selection Assay

Intervention Type DEVICE

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.

ICSI

Intervention Type PROCEDURE

An in vitro fertilization procedure in which a single sperm is injected directly into an egg

ICSI + SSA Attractant substance

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)

Group Type EXPERIMENTAL

Sperm Selection Assay

Intervention Type DEVICE

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 Substance

Intervention Type OTHER

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

ICSI

Intervention Type PROCEDURE

An in vitro fertilization procedure in which a single sperm is injected directly into an egg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sperm Selection Assay

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.

Intervention Type DEVICE

Attractant Substance

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

Intervention Type OTHER

ICSI

An in vitro fertilization procedure in which a single sperm is injected directly into an egg

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

SSA Intracytoplasmatic Sperm Injection

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

* Males with oligoasthenoteratozoospermia and oligoasthenozoospermia.

Exclusion Criteria

* Low complexity assisted reproductive techniques
* In vitro fertilization treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidad Nacional de Córdoba

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Carlos López

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Laura C. Giojalas, PhD

Role: PRINCIPAL_INVESTIGATOR

National University of Cordoba

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

HALITUS Instituto Médico

Buenos Aires, Buenos Aires F.D., Argentina

Site Status RECRUITING

Instituto Universitario de Medicina Reproductiva (IUMER)

Córdoba, Córdoba Province, Argentina

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Argentina

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Laura C Giojalas, PhD

Role: CONTACT

0054 - 351 - 5353800 ext. 30300

Maria J. Figueras, PhD

Role: CONTACT

0054 - 9351 - 2209799 ext. 30300

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Rodolfo A Pasqualini

Role: primary

+54 11 5273 2000

Ines Carretero

Role: backup

+54 11 5273 2000

Ana M Babini, MD

Role: primary

0054 - 351 - 4331050

Maria J. Figueras, PhD

Role: backup

0054 - 9351 - 2209799

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PIDC2014-0016

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IUMER-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Sex Selection of Human Spermatozoa
NCT05500573 RECRUITING NA