What is the mechanism of action of this treatment?

Common treatments for male infertility often involve assisted reproductive technologies (ART) that directly manipulate sperm or spermatids to facilitate fertilization. Intracytoplasmic sperm injection (ICSI) involves injecting a single sperm directly into an egg, which is particularly useful for men with low sperm count or poor sperm motility. Round Spermatid Injection (ROSI) is a similar technique where immature spermatids are injected into oocytes to create embryos, offering hope for men with non-obstructive azoospermia who lack mature sperm. These treatments are crucial as they provide viable options for achieving pregnancy in cases where natural conception is not possible due to severe male infertility factors.

What side effects are associated with this type of intervention?

Common treatments for male infertility, such as testicular sperm extraction (TESE) and microdissection TESE (microTESE), can have side effects including pain, swelling, and infection at the surgical site. Additionally, there is a risk of testicular damage and reduced testosterone production. Intracytoplasmic sperm injection (ICSI), which involves injecting a single sperm into an egg, carries risks such as potential damage to the egg and a slightly increased risk of genetic abnormalities in the offspring. However, the absolute risk of these genetic issues remains low.

What prior FDA approvals exist?

FDA-approved treatments for male infertility primarily include hormone therapies such as gonadotropins (FSH and LH) and medications like clomiphene citrate, which stimulate spermatogenesis. Surgical techniques like Testicular Sperm Extraction (TESE) and microTESE are also utilized, particularly for men with non-obstructive azoospermia. These methods retrieve sperm directly from the testes for use in assisted reproductive technologies like Intracytoplasmic Sperm Injection (ICSI). While Round Spermatid Injection (ROSI) is being studied, it is not yet an FDA-approved treatment.

What other types of research exist?

Promising alternatives to Round Spermatid Injection (ROSI) for male infertility patients include Intracytoplasmic Sperm Injection (ICSI), Testicular Sperm Extraction (TESE) combined with ICSI, and the use of Preimplantation Genetic Testing (PGT) to select healthy embryos.

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Procedure

ROSI for Male Infertility (ROSI Trial)

N/A

Recruiting

Led By Hooman Sadri, MD, PhD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

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

Must have

Male partner ≥18

Male diagnosed with non-obstructive Azoospermia

Must not have

Males with obstructive azoospermia

Males with presence an adequate number of elongated spermatids or spermatozoa

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post pregnancy full term average 39 to 40 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a procedure that uses immature sperm cells to help men who can't produce mature sperm have biological children. The process involves selecting these cells and injecting them into an egg, with extra steps to ensure the egg is ready to develop. This technique has been explored as an alternative for men who cannot produce mature sperm.

Who is the study for?

This trial is for couples facing male infertility due to non-obstructive azoospermia, where the man lacks mature sperm in his semen. Men must have round spermatids present and be over 18 years old. Women partners should be between 18-38 years or have an AMH level above 2 ng/ml.

What is being tested?

The study tests if injecting round spermatids directly into eggs (ROSI) can lead to pregnancy in cases of severe male infertility. It compares ROSI with using half donor sperm to see which is safer and more effective at creating viable embryos.

What are the potential side effects?

Potential side effects are not specified but may include risks associated with IVF-like procedures such as multiple pregnancies, emotional stress, and complications from egg retrieval or embryo transfer.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My male partner is 18 years old or older.

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I am a male diagnosed with a condition where I produce no sperm.

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My test results show only round spermatids, no mature sperm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am a male diagnosed with obstructive azoospermia.

Select...

My sperm test shows a normal count.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post pregnancy full term average 39 to 40 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post pregnancy full term average 39 to 40 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and post pregnancy full term average 39 to 40 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fertility rate

Secondary study objectives

Aneuploidy rate

Blastocyst formation

Chemical Pregnancy with Positive human chorionic gonadotropin (hCG)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: ROSI onlyExperimental Treatment1 Intervention

Option 1: injecting extracted round spermatids (less mature form of haploid germ cells than elongated spermatid or spermatozoon) from male partner into the harvested egg of a female partner

Group II: Half ROSI-half Sperm Donor FertilizationExperimental Treatment1 Intervention

Option 2: Harvested eggs from the female partner will be separated in two groups, with one group being fertilized with round spermatids and the other group fertilized with donor sperm

0 / 5Eligibility criteria met

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 male infertility often involve assisted reproductive technologies (ART) that directly manipulate sperm or spermatids to facilitate fertilization. Intracytoplasmic sperm injection (ICSI) involves injecting a single sperm directly into an egg, which is particularly useful for men with low sperm count or poor sperm motility. Round Spermatid Injection (ROSI) is a similar technique where immature spermatids are injected into oocytes to create embryos, offering hope for men with non-obstructive azoospermia who lack mature sperm. These treatments are crucial as they provide viable options for achieving pregnancy in cases where natural conception is not possible due to severe male infertility factors.

The role of DEFB126 variation in male infertility and medically assisted reproduction technique outcome.