Sex Selection of Human Spermatozoa

Study Overview
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Brief Summary
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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
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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.

Official Title
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Sex Selection of Human Spermatozoa

Conditions
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IVF, Infertility

Intervention / Treatment
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* Procedure: Sperm Sorting


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sperm sorting<br>Selection of gender specific spermatozoa using a multilayer density gradient | Procedure: Sperm Sorting<br>* Selection of gender specific spermatozoa using a multilayer density gradient solution<br>* Other names: Sperm Sex Selection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |