Sex Selection of Human Spermatozoa

Not Applicable

Recruiting

• Conditions: IVF; Infertility
• Interventions: Procedure: Sperm Sorting

• Registration Number: NCT05500573
• Lead Sponsor: Weill Medical College of Cornell University

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.

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 Timeline

• Study Start: 2013-11-06
• Study First Submitted: 2022-08-11
• Study First Submitted QC: 2022-08-11
• Study First Posted: 2022-08-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-01
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sperm sorting	Sperm Sorting	Selection of gender specific spermatozoa using a multilayer density gradient

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Center for Reproductive Medicine- Weill Cornell Medicine; 🇺🇸 New York, New York, United States