Skip to content

Sex Selection of Human Spermatozoa

Sex Selection of Human Spermatozoa

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05500573
Enrollment
2000
Registered
2022-08-15
Start date
2013-11-06
Completion date
2029-12-31
Last updated
2026-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, IVF

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.

Interventions

PROCEDURESperm Sorting

Selection of gender specific spermatozoa using a multilayer density gradient solution

Sponsors

Weill Medical College of Cornell University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
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

Design outcomes

Primary

MeasureTime frame
Rate of gender bearing spermatozoa after 4-layer density gradient8 years
Rate of embryos of the desired gender in couples8 years
Rate of offspring of the desired gender in couples8 years

Countries

United States

Contacts

CONTACTRodriq Stubbs, MS, NP
res2011@med.cornell.edu646-962-3276
CONTACTStephanie Cheung
stc3001@med.cornell.edu646-962-8448
PRINCIPAL_INVESTIGATORGianpiero Palermo, MD, PhD

Weill Medical College of Cornell University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 30, 2026