Sex Selection of Human Spermatozoa

NCT ID: NCT05500573

Last Updated: 2025-06-24

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

RECRUITING

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-06

Study Completion Date

2027-12-31

Brief Summary

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

This study aims to demonstrate a reliable method of selecting gender specific sperm. X-bearing spermatozoa and Y-bearing spermatozoa will be identified from the density gradient layers. The selected gender specimen will then be utilized for assisted reproductive fertilization- in vitro fertilization or intrauterine insemination which are routine standard of care procedures.

Detailed Description

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

The study aim is to test a simple, reliable, and inexpensive method to attempt selection of gender specific spermatozoa. Couples will undergo evaluation and treatment according to the standard clinic procedures. Sperm samples provided for infertility treatment will be further analyzed routine semen analysis for volume, concentration, mobility and morphology. Sperm samples will be provided by consenting males undergoing infertility treatment. A multilayer density gradient will be performed utilizing an FDA approved solution, Enhance-S Plus Cell Isolation Media (Vitrolife, San Diego, CA).

This density gradient is also used for standard semen preparation for intrauterine insemination. X-bearing spermatozoa and Y-bearing spermatozoa will be identified from the density gradient fractions. Sperm suspensions will be smeared on slides for FISH analysis using centromeric probes for chromosomes 18, X, and Y. The ratio of X- to Y- chromosome bearing spermatozoa will be assessed as a percentage on at least 200 cells per slide. Aneuploid cells and those without signals will be omitted. Unselected fractions of each sample will serve as controls. The rate of X-bearing spermatozoa after 4-layer density gradient will be calculated. After thorough counseling, the selected preconception gender specimen will then be utilized for assisted reproductive fertilization- in vitro fertilization with or without intracytoplasmic sperm injection (ICSI) or intra uterine insemination which are routine standard of care procedures.

Conditions

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

Infertility IVF

Study Design

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

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Sperm ejaculates are processed by an in-house protocol that utilized a multilayer density gradient comprised of four concentrations: 20%, 40%, 60%, and 90% to attempt selection of gender specific spermatozoa.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Sperm sorting

Selection of gender specific spermatozoa using a multilayer density gradient

Group Type EXPERIMENTAL

Sperm Sorting

Intervention Type PROCEDURE

Selection of gender specific spermatozoa using a multilayer density gradient solution

Interventions

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

Sperm Sorting

Selection of gender specific spermatozoa using a multilayer density gradient solution

Intervention Type PROCEDURE

Other Intervention Names

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

Sperm Sex Selection

Eligibility Criteria

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

Inclusion Criteria

* Couples undergoing infertility treatment with IVF or insemination seeking gender specific offspring for medical and non medical reasons

Exclusion Criteria

* Severe male factor
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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

Responsibility Role SPONSOR

Principal Investigators

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

Gianpiero Palermo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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

Center for Reproductive Medicine- Weill Cornell Medicine

New York, New York, United States

Site Status RECRUITING

Countries

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

United States

Central Contacts

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

Rodriq Stubbs, MS, NP

Role: CONTACT

646-962-3276

Stephanie Cheung

Role: CONTACT

646-962-8448

Facility Contacts

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

Rodriq Stubbs, MS, NP

Role: primary

646-962-3276

Stephanie Cheung

Role: backup

646-962-8448

References

Explore related publications, articles, or registry entries linked to this study.

Cheung S, Elias R, Xie P, Rosenwaks Z, Palermo GD. A non-randomized clinical trial to determine the safety and efficacy of a novel sperm sex selection technique. PLoS One. 2023 Mar 22;18(3):e0282216. doi: 10.1371/journal.pone.0282216. eCollection 2023.

Reference Type DERIVED
PMID: 36947521 (View on PubMed)

Other Identifiers

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

1306014043

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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