Sex Selection of Human Spermatozoa

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.

Study Overview

• Status: Recruiting
• Conditions: Infertility; IVF
• Intervention / Treatment: Procedure: Sperm Sorting

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rodriq Stubbs, MS, NP; Phone Number: 646-962-3276; Email: res2011@med.cornell.edu
• Study Contact Backup: Name: Stephanie Cheung; Phone Number: 646-962-8448; Email: stc3001@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Center for Reproductive Medicine- Weill Cornell Medicine
      • Contact: Rodriq Stubbs, MS, NP; Phone Number: 646-962-3276; Email: res2011@med.conrell.edu
      • Contact: Stephanie Cheung; Phone Number: 646-962-8448; Email: cts3001@med.conrell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sperm sorting; Selection of gender specific spermatozoa using a multilayer density gradient	Procedure: Sperm Sorting; Selection of gender specific spermatozoa using a multilayer density gradient solution; Other Names: Sperm Sex Selection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Gianpiero Palermo, MD, PhD, Weill Medical College of Cornell University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2013
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: August 11, 2022
• First Submitted That Met QC Criteria: August 11, 2022
• First Posted (Actual): August 15, 2022

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: 1306014043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No