Experimental Round Spermatid Injection (ROSI) to Treat Infertile Couples

NCT04298255 | Recruiting

• 1 other identifier: IRB00062898
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to evaluate if special types of cells called round spermatids can be gathered from men with non-obstructive azoospermia and used (in absence of elongated spermatids and spermatozoa) to reliably and effectively create pregnancy with a procedure called Round Spermatid Injection (ROSI). This process is similar to In Vitro Fertilization, or 'IVF'. In addition, this study wants to test the safety of ROSI and see what effects (good and bad) it has on embryo created from this method.

Conditions

Infertility, Male

Keywords

IVF; Fertility

Outcome Measures

Primary Outcomes (1)

• Fertility rate

  Egg fertilization comparison between the groups undergoing the procedure with spermatids only vs spermatids and donor sperms.This fertilization process will be recorded by EmbryoScope under supervision of dedicated clinical embryologist.All the process will be followed and documented according to America Society of Reproductive Medicine (ASRM) guidelines. All the process will be followed and documented according to American Society for Reproductive Medicine (ASRM) guidelines.

  Day 1 after round spermatid injection

Secondary Outcomes (4)

• Blastocyst formation

  Day 3 to 5 after round spermatid injection

• Aneuploidy rate

  Day 3 to 5 after round spermatid injection

• Chemical Pregnancy with Positive human chorionic gonadotropin (hCG)

  Post Fertilization 4 Weeks and onwards

• Live Birth Rate

  Post Pregnancy Full Term Average 39 to 40 weeks

Study Arms (2)

ROSI only

EXPERIMENTAL

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

Other: Round Spermatid Injection (ROSI)

Half ROSI-half Sperm Donor Fertilization

EXPERIMENTAL

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

Other: Half ROSI-half Sperm Donor Fertilization

Interventions

Round Spermatid Injection (ROSI) OTHER

In Vitro Fertilization using Round Spermatid Injection (ROSI)

ROSI only

Half ROSI-half Sperm Donor Fertilization OTHER

Half ROSI-half Sperm Donor Fertilization

Half ROSI-half Sperm Donor Fertilization

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Males with absence of elongated spermatids or spermatozoa, but having round spermatids present on TESE (Testicular Sperm Extraction) Male diagnosed with non-obstructive Azoospermia Female partner 18≤ X≤38 years of age (because of expected lower quality of oocytes in older females)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males with no elongated spermatids or spermatozoa present but with round spermatids present on TESE (Testicular Sperm Extraction)
• Male diagnosed with non-obstructive Azoospermia
• Male partner ≥18
• Female partner greater than 18 years of age and less than 38 years of age or Anti Mullerian Hormone (AMH) greater than 2 ng/ml.

You may not qualify if:

• Males with obstructive azoospermia
• Males with presence an adequate number of elongated spermatids or spermatozoa

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Carolinas Fertility Institute (CFI): collaborator
• Wake Forest Institute for Regenerative Medicine (WFIRM): collaborator
• Wake Forest Department of Urology: collaborator

Study Sites (1)

Carolinas Fertility Institute (CFI)

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Related Publications (3)

• Tanaka A, Suzuki K, Nagayoshi M, Tanaka A, Takemoto Y, Watanabe S, Takeda S, Irahara M, Kuji N, Yamagata Z, Yanagimachi R. Ninety babies born after round spermatid injection into oocytes: survey of their development from fertilization to 2 years of age. Fertil Steril. 2018 Aug;110(3):443-451. doi: 10.1016/j.fertnstert.2018.04.033.

  PMID: 30098696 BACKGROUND

• Tanaka A, Nagayoshi M, Takemoto Y, Tanaka I, Kusunoki H, Watanabe S, Kuroda K, Takeda S, Ito M, Yanagimachi R. Fourteen babies born after round spermatid injection into human oocytes. Proc Natl Acad Sci U S A. 2015 Nov 24;112(47):14629-34. doi: 10.1073/pnas.1517466112. Epub 2015 Nov 2.

  PMID: 26575628 BACKGROUND

• Bradshaw AW, Nikmehr B, Halicigil C, Stogner-Underwood K, Sadri-Ardekani H. Optimum identification of round spermatid in men with non-obstructive azoospermia: A commentary. Andrology. 2021 Nov;9(6):1817-1818. doi: 10.1111/andr.13113. Epub 2021 Oct 14. No abstract available.

  PMID: 34618410 BACKGROUND

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Officials

• Hooman Sadri, MD, PhD

  Wake Forest Institute for Regenerative Medicine (WFIRM)

  PRINCIPAL INVESTIGATOR

• Hooman Sadri, MD, PhD

  Wake Forest University Health Sciences

  STUDY DIRECTOR

Central Study Contacts

Karla M Oliver

CONTACT

336-713-3123; kaoliver@wakehealth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Infertile Male with round spermatid (but not elongated spermatids and spermatozoa) in their testes. Couples can choose either option 1 or 2.

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 6, 2020
• Study Start: August 24, 2020
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)