Sperm Sorting for Gender Selection in Infertility Treatment

Overseen By Stephanie Cheung

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Severe male factor

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

2000 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

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. ^{1 2 5 6 7}

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. ^{1 2 4 8 9}

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.

Research Team

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.

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

Trial Overview The 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

Group I: Sperm sorting Experimental Treatment 1 Intervention

Selection of gender specific spermatozoa using a multilayer density gradient

Sperm Sorting is already approved in United States, European Union for the following indications:

Approved in United States as Sperm Sorting for:

• Family balancing
• Avoidance of sex-linked genetic diseases

Approved in European Union as Sperm Sorting for:

• Family balancing
• Avoidance of sex-linked genetic diseases

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sex-selection of human spermatozoa: evolution of current techniques and applications. Sills, ES., Kirman, I., Thatcher, SS., et al.[2019]

Timing of intercourse relative to ovulation can subtly influence the sex ratio, with more females conceived close to ovulation and more males when sperm or egg are present longer before conception, but this method is not practical for individual couples.

Sperm separation techniques, particularly using albumin or Sephadex column filtration, have shown clinically relevant success rates of 70-80% for selecting Y-bearing sperm and 75-80% for X-bearing sperm, making them the most effective methods for sex selection currently available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical relevance of sex selection techniques. Zarutskie, PW., Muller, CH., Magone, M., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sex selection by sperm separation and insemination. Corson, SL., Batzer, FR., Alexander, NJ., et al.[2017]

Noninvasive sperm sorting techniques for gender selection present a safer alternative to invasive procedures, but they are not always accurate in producing the desired sex of the offspring.

The growing trend of using sperm sorting for 'family balancing' raises ethical concerns, and further research is needed to understand the implications of gender selection on families before it becomes a standard practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gender selection: pressure from patients and industry should not alter our adherence to ethical guidelines. Sauer, MV.[2007]

The current method for sexing mammalian sperm using flow cytometry is over 90% accurate but has significant limitations, including high costs, low sorting rates, and potential damage to sperm that can affect fertility, although it does not lead to offspring abnormalities.

Research is ongoing to improve sperm sexing techniques, with a focus on developing more efficient methods that can sort millions of sperm simultaneously while maintaining accuracy and minimizing damage, which is crucial for future commercialization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sexing mammalian sperm - Where do we go from here? Seidel, GE.[2022]

A novel sperm sex selection technique (SST) was shown to effectively enrich spermatozoa for the desired sex, achieving an 81.6% enrichment for female offspring and 80.8% for male offspring in a clinical trial involving 1,317 couples.

The SST did not negatively impact fertilization rates or embryo development, with high implantation rates and healthy deliveries, indicating that this method is both safe and effective for couples seeking to select the sex of their offspring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A non-randomized clinical trial to determine the safety and efficacy of a novel sperm sex selection technique. Cheung, S., Elias, R., Xie, P., et al.[2023]

Australian researchers found that techniques used to sort sperm for selecting the sex of children are ineffective.

This conclusion suggests that current methods do not reliably allow couples to choose the sex of their offspring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sperm separating techniques do not work. [2019]

Current methods for selecting the gender of offspring, such as sperm separation techniques, generally do not achieve high effectiveness in influencing sex ratios, as most methods fail to meet the necessary criteria for complete separation and viability of sperm.

Among the various techniques, only the method of sorting sperm based on chromatin differences using flow cytometry has shown significant success in enriching X-bearing sperm, indicating a potential avenue for more effective sex selection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

X-Y sperm selection: fact or fiction? Michelmann, HW., Gratz, G., Hinney, B.[2019]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Scientific aspects of preconception gender selection. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Sex-selection of human spermatozoa: evolution of current techniques and applications. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

The clinical relevance of sex selection techniques. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Sex selection by sperm separation and insemination. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Gender selection: pressure from patients and industry should not alter our adherence to ethical guidelines. [2007]

6. Japan pubmed.ncbi.nlm.nih.gov

Sexing mammalian sperm - Where do we go from here? [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A non-randomized clinical trial to determine the safety and efficacy of a novel sperm sex selection technique. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Sperm separating techniques do not work. [2019]

9. England pubmed.ncbi.nlm.nih.gov

X-Y sperm selection: fact or fiction? [2019]