What side effects are associated with this type of intervention?

Common treatments for infertility that involve techniques similar to density gradient separation, such as intrauterine insemination (IUI) and in vitro fertilization (IVF), can have several side effects. These may include mild cramping, spotting, and discomfort during or after the procedure. Hormonal treatments used in conjunction with these procedures can cause side effects such as mood swings, headaches, bloating, and ovarian hyperstimulation syndrome (OHSS), which can lead to swollen, painful ovaries. Additionally, there is a risk of multiple pregnancies, which can increase the likelihood of complications for both the mother and the babies.

What prior FDA approvals exist?

FDA-approved treatments for infertility often involve assisted reproductive technologies (ART) such as in vitro fertilization (IVF) and intrauterine insemination (IUI). Techniques like density gradient centrifugation, which are used for sperm selection, are commonly employed in these procedures to enhance the quality of sperm used. While specific drugs for sperm selection are not mentioned, ART procedures frequently use hormonal treatments such as gonadotropins to stimulate ovulation in women, and medications like clomiphene citrate to induce ovulation. These methods aim to improve the chances of successful fertilization and pregnancy.

What other types of research exist?

Promising novel alternatives to density gradient separation for gender-specific sperm selection in infertility treatment include: 1) Microfluidic sperm sorting, which uses microchannels to select the most motile and morphologically normal sperm, 2) Magnetic-Activated Cell Sorting (MACS), which uses magnetic fields to separate apoptotic sperm from healthy sperm, and 3) Raman spectroscopy, a non-invasive technique that identifies sperm with the best DNA integrity based on their molecular composition. These methods have shown potential in improving fertilization rates and overall treatment outcomes.

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Sperm Sorting for Gender Selection in Infertility Treatment

N/A

Recruiting

Led By Gianpiero Palermo, MD, PhD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the intervention involves standard fertility procedures, potential side effects may include discomfort from sperm collection and typical risks associated with IVF or insemination, like multiple pregnancies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

1Treatment groups

Experimental Treatment

Group I: Sperm sortingExperimental Treatment1 Intervention

Selection of gender specific spermatozoa using a multilayer density gradient

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for infertility include ovulation induction, assisted reproductive technologies (ART) such as in vitro fertilization (IVF), and sperm retrieval techniques. Ovulation induction uses medications like clomiphene citrate or gonadotropins to stimulate the ovaries to produce eggs. ART involves retrieving eggs and sperm, fertilizing them outside the body, and transferring the embryo back into the uterus. Sperm retrieval techniques, such as testicular sperm extraction (TESE), are used when men have low or no sperm in their ejaculate. These treatments are crucial as they address specific causes of infertility, increasing the chances of conception. Gender-specific sperm selection, like density gradient separation, is a method used to select sperm carrying a specific sex chromosome, which can be used in ART to influence the gender of the offspring. This matters for infertility patients as it provides more control over reproductive outcomes and can be particularly important for those with genetic concerns.

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Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

1,077 Previous Clinical Trials

1,318,667 Total Patients Enrolled

24 Trials studying Infertility

6,515 Patients Enrolled for Infertility

Gianpiero Palermo, MD, PhDPrincipal InvestigatorWeill Medical College of Cornell University

1 Previous Clinical Trials

1,200 Total Patients Enrolled

1 Trials studying Infertility

1,200 Patients Enrolled for Infertility

Media Library

Sperm Sorting (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05500573 — N/A

Infertility Research Study Groups: Sperm sorting

Infertility Clinical Trial 2023: Sperm Sorting Highlights & Side Effects. Trial Name: NCT05500573 — N/A

Sperm Sorting (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05500573 — N/A

Infertility Patient Testimony for trial: Trial Name: NCT05500573 — N/A

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