Sex Selection of Human Spermatozoa

NCT05500573 | Recruiting

• 1 other identifier: 1306014043
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infertility; IVF

Outcome Measures

Primary Outcomes (3)

• Rate of gender bearing spermatozoa after 4-layer density gradient

  8 years

• Rate of embryos of the desired gender in couples

  8 years

• Rate of offspring of the desired gender in couples

  8 years

Study Arms (1)

Sperm sorting

EXPERIMENTAL

Selection of gender specific spermatozoa using a multilayer density gradient

Procedure: Sperm Sorting

Interventions

Sperm Sorting PROCEDURE

Selection of gender specific spermatozoa using a multilayer density gradient solution

Also known as: Sperm Sex Selection

Sperm sorting

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Severe male factor

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Center for Reproductive Medicine- Weill Cornell Medicine

New York, New York, 10021, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 36947521 DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Gianpiero Palermo, MD, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodriq Stubbs, MS, NP

CONTACT

646-962-3276; res2011@med.cornell.edu

Stephanie Cheung

CONTACT

646-962-8448; stc3001@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 15, 2022
• Study Start: November 6, 2013
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)