Sex Selection of Human Spermatozoa

Infertility Clinical Trial

Official title:

Sex Selection of Human Spermatozoa

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05500573
• Other study ID #: 1306014043
• Status: Recruiting
• Phase: N/A
• Start date: November 6, 2013
• Est. completion date: December 31, 2026

Study information

• Verified date: August 2023
• Source: Weill Medical College of Cornell University
• Contact: Rodriq Stubbs, MS, NP
• Phone: 646-962-3276
• Email: res2011[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• IVF

Intervention

Procedure:
• Sperm Sorting
Selection of gender specific spermatozoa using a multilayer density gradient solution

Locations

Country	Name	City	State
United States	Center for Reproductive Medicine- Weill Cornell Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of gender bearing spermatozoa after 4-layer density gradient		8 years
Primary	Rate of embryos of the desired gender in couples		8 years
Primary	Rate of offspring of the desired gender in couples		8 years