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Sex Selection of Human Spermatozoa

Sponsor
Weill Medical College of Cornell University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05500573
Collaborator
(none)
2,000
Enrollment
1
Location
1
Arm
133.8
Anticipated Duration (Months)
14.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Sperm Sorting
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
2000 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Sex Selection of Human Spermatozoa
Actual Study Start Date :
Nov 6, 2013
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Rate of gender bearing spermatozoa after 4-layer density gradient [8 years]

    2. Rate of embryos of the desired gender in couples [8 years]

    3. Rate of offspring of the desired gender in couples [8 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 89 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Center for Reproductive Medicine- Weill Cornell Medicine New York New York United States 10021

    Sponsors and Collaborators

    • Weill Medical College of Cornell University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Weill Medical College of Cornell University
    ClinicalTrials.gov Identifier:
    NCT05500573
    Other Study ID Numbers:
    • 1306014043
    First Posted:
    Aug 15, 2022
    Last Update Posted:
    Aug 15, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infertility

    Study Results

    No Results Posted as of Aug 15, 2022