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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a method to sort sperm by gender for use in infertility treatments like IVF (in vitro fertilization) or insemination. The goal is to select male or female sperm to help couples choose their child's gender. Known as Sperm Sorting, this method could assist for medical reasons or personal preference. Couples currently undergoing infertility treatments who wish to select their child's gender may be eligible to join. As an unphased trial, participants can contribute to pioneering research that may offer new options for family planning.

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 prior data suggests that this sperm sorting method is safe for gender selection in infertility treatment?

Research has shown that methods for choosing a baby's gender by sorting sperm are generally safe. Clinical trials indicate that these techniques result in pregnancy and birth defect rates similar to those in the general population. Couples using sperm sorting for gender selection can expect outcomes comparable to regular fertility treatments. One study found that these sorting methods do not harm sperm function. Overall, current evidence suggests that sperm sorting is well-tolerated, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about sperm sorting for gender selection in infertility treatment because it offers a new way to potentially influence the gender of a child before conception. Unlike traditional methods like IVF that focus on fertilization and embryo selection, this technique uses a multilayer density gradient to sort spermatozoa based on gender-specific characteristics. This method could provide a more targeted approach, minimizing the need for invasive procedures and allowing for a more natural conception process.

What evidence suggests that sperm sorting is effective for gender selection in infertility treatment?

Research has shown that sperm sorting methods, such as the Ericsson Method, can significantly increase the number of sperm carrying either the X or Y chromosome. In this trial, participants will undergo sperm sorting, which has achieved success rates of up to 80% for selecting the desired gender. Other studies indicate that sperm sorting offers a 70% to 80% chance of selecting a girl and a 60% to 70% chance of selecting a boy. However, some techniques have produced mixed results in gender selection. Overall, sperm sorting effectively alters the balance of X and Y sperm without harming sperm function. ^{1 2 4 5 6}

Who Is on the Research Team?

Gianpiero Palermo, MD, PhD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10032484/

A non-randomized clinical trial to determine the safety and ... This technique is effective at increasing overall sperm motility, but when applied for sperm sex selection, it has yielded inconsistent results ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05500573

NCT05500573 | Sex Selection of Human Spermatozoa 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4256056/

The effectiveness of flow cytometric sorting of human sperm ... Flow cytometric sorting of human sperm shifted the X:Y sperm ratio. IUI, IVF/ICSI and FET outcomes were consistent with unimpaired sperm function.

4. withpower.com withpower.com/trial/phase-infertility-10-2013-add37

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 ...

5. pfcla.com pfcla.com/blog/what-is-sperm-sorting

PGT-A Testing vs. Sperm Sorting: What's the Difference? Some published studies shows that sperm sorting has a 70% - 80% chance of successfully selecting a female, and 60% - 70% for selecting a male.

6. spermbankcalifornia.com spermbankcalifornia.com/fertility-services/gender-sex-selection

Gender & Sex Selection Services | Sperm Bank ... Clinical data suggests that The Ericsson Method of sex selection produced a success rate of 70-72% for male sex selection, and 69-75% for female gender ...