~255 spots leftby Dec 2026

Sperm Sorting for Gender Selection in Infertility Treatment

Recruiting in Palo Alto (17 mi)
GP
Overseen byGianpiero Palermo, MD, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Weill Medical College of Cornell University
Disqualifiers: Severe male factor
No Placebo Group
Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing a method to choose sperm that will result in either a boy or a girl before fertilization. It targets couples undergoing infertility treatment. The process involves sorting sperm by density to identify male or female sperm, then using them for fertilization procedures like IVF or intrauterine insemination.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Sperm Sorting for Gender Selection in Infertility Treatment?

Research shows that sperm sorting methods, like the Ericsson Method, can significantly enrich X- or Y-chromosome bearing sperm, achieving up to 80% success in selecting the desired gender. Clinical trials indicate that these methods are safe and effective, with pregnancy rates and congenital abnormality rates similar to those in the general population.12345

Is sperm sorting for gender selection safe for humans?

Research shows that sperm sorting for gender selection is generally safe, with clinical loss rates and congenital abnormality rates similar to those in the general population. The method does not impair fertilization or embryo development, and offspring health is not affected.12567

How does the Sperm Sorting treatment for gender selection differ from other treatments?

Sperm Sorting for gender selection is unique because it attempts to separate sperm based on physical or nuclear characteristics to enrich for X or Y chromosome-bearing sperm, allowing for preconception gender selection. This method can help reduce the risk of X-linked diseases and achieve family balancing, unlike other treatments that do not offer targeted gender selection.12489

Research Team

GP

Gianpiero Palermo, MD, PhD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

This trial is for couples undergoing infertility treatments like IVF or insemination who wish to select the gender of their offspring, whether for medical or non-medical reasons. Couples with severe male factor infertility cannot participate.

Inclusion Criteria

My partner and I are using IVF or insemination to choose our baby's gender.

Exclusion Criteria

I have a significant fertility issue as a man.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Evaluation and Treatment

Couples undergo evaluation and treatment according to standard clinic procedures, including sperm sample analysis and gender-specific sperm selection

4-6 weeks

Assisted Reproductive Fertilization

Selected gender-specific sperm is used for in vitro fertilization or intrauterine insemination

1-2 weeks

Follow-up

Participants are monitored for outcomes of the assisted reproductive procedures

4 weeks

Treatment Details

Interventions

  • Sperm Sorting (Other)
Trial OverviewThe study tests a method to choose sperm based on desired gender before using them in standard fertility treatments such as in vitro fertilization (IVF) or intrauterine insemination.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Sperm sortingExperimental Treatment1 Intervention
Selection of gender specific spermatozoa using a multilayer density gradient

Find a Clinic Near You

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials
1,103
Recruited
1,157,000+
Dr. Robert Min profile image

Dr. Robert Min

Weill Medical College of Cornell University

Chief Executive Officer since 2024

MD, MBA

Dr. Adam R. Stracher profile image

Dr. Adam R. Stracher

Weill Medical College of Cornell University

Chief Medical Officer since 2024

MD

Findings from Research

The MicroSort method for preconception gender selection is both safe and effective, successfully shifting the ratio of X and Y chromosome-bearing sperm from a natural 50:50 to 90% X or 75% Y after sorting, as confirmed by fluorescence in-situ hybridization (FISH) analysis.
Pregnancy rates from intrauterine insemination (IUI) and IVF/ICSI using sorted sperm are comparable to standard assisted reproduction rates, and the rate of major congenital abnormalities in babies born from this method (2.05%) aligns with the general population, indicating no increased risk.
Scientific aspects of preconception gender selection.Schulman, JD., Karabinus, DS.[2022]
Sperm sorting methods for sex selection have been around for years and can potentially help eliminate sex-linked conditions and assist in family balancing, but their efficiency and reproducibility are still debated.
Two main approaches exist for sperm sorting: one based on physical or kinetic features and another on chromatin differences, with the latter showing promise for effectively enriching X- or Y-chromosome bearing sperm, although human clinical experience is still limited.
Sex-selection of human spermatozoa: evolution of current techniques and applications.Sills, ES., Kirman, I., Thatcher, SS., et al.[2019]
The Ericsson albumin filtration technique successfully enriched Y sperm for selective insemination, resulting in 80% male births among 35 known conceptions, indicating its efficacy for couples desiring male infants.
The technique also allows for the selective enrichment of X sperm, with 12 pregnancies resulting in 7 females and 2 males, demonstrating its potential for sex selection based on medical needs, such as avoiding male offspring in families with sex-linked diseases.
Sex selection by sperm separation and insemination.Corson, SL., Batzer, FR., Alexander, NJ., et al.[2017]

References

Scientific aspects of preconception gender selection. [2022]
Sex-selection of human spermatozoa: evolution of current techniques and applications. [2019]
The clinical relevance of sex selection techniques. [2019]
Sex selection by sperm separation and insemination. [2017]
Gender selection: pressure from patients and industry should not alter our adherence to ethical guidelines. [2007]
Sexing mammalian sperm - Where do we go from here? [2022]
A non-randomized clinical trial to determine the safety and efficacy of a novel sperm sex selection technique. [2023]
Sperm separating techniques do not work. [2019]
X-Y sperm selection: fact or fiction? [2019]