NCT04452305

Brief Summary

Spermatogonial stem cell transplantation through ultrasound guided rete testis injection and testicular tissue grafting will be performed for participants who have frozen testicular tissue prior to gonadotoxic therapy. The purpose of this study is to test the safety and feasibility of these transplant technologies and restore fertility for these participants.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
50mo left

Started Nov 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Nov 2023May 2030

First Submitted

Initial submission to the registry

June 18, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 30, 2020

Completed
3.4 years until next milestone

Study Start

First participant enrolled

November 10, 2023

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2029

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2030

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

6.1 years

First QC Date

June 18, 2020

Last Update Submit

April 18, 2026

Conditions

Infertility, MaleCancerAutoimmune Disorder

Keywords

spermatogonial stem cellstestisfertilityoncofertility

Outcome Measures

Primary Outcomes (1)

  • Number of participants with return of spermatogenesis

    Rate of participants where sperm was found in semen analysis or testicular tissue analysis

    3 months-1year

Secondary Outcomes (2)

  • Number of participants with cancer recurrence

    5 years

  • Number of participants with surgical complications of SSC transplantation and testicular tissue grafting

    3 months

Study Arms (1)

Spermatogonial Stem Cell Transplant & Testicular Tissue Graft

EXPERIMENTAL

Stem cell transplantation Testicular tissue grafting

Procedure: Spermatogonial Stem Cell Transplant and Testicular Tissue Grafting

Interventions

Spermatogonial Stem Cell Transplant and Testicular Tissue GraftingPROCEDURE

Spermatogonial stem cell transplant and testicular tissue grafting is performed to produce sperm.

Spermatogonial Stem Cell Transplant & Testicular Tissue Graft

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male participant at least in Tanner stage 3
  • Previously cryopreserved and stored testicular tissue/cells (frozen due to an infertility-risking diagnosis or treatment such as chemotherapy or radiation) available for autologous transplantation and grafting
  • Healthy enough to undergo anesthesia
  • Written clearance for the procedure from the patient's hematologist or oncologist to confirm the patient has finished treatment for primary condition and are clear to undergo autologous stem cell transplant

You may not qualify if:

  • Participants considered to be high risk for surgical complications
  • Participants with a history of leukemia, lymphoma or testicular cancer or a cancer that likely involved testicles at the time of testicular tissue collection
  • Diagnosed with psychological, psychiatric, or other conditions which prevent giving fully informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Related Publications (1)

  • Zielen AC, Peters KA, Shetty G, Gross DA, Hanna CB, Dovey SL, Wecht A, Cannon GM, Meistrich ML, Hsieh M, Hwang K, Orwig KE. Ultrasound-Guided Rete Testis Approach to Sperm Aspiration and Spermatogonial Stem Cell Transplantation in Patients with Azoospermia. medRxiv [Preprint]. 2025 Mar 26:2025.03.25.25324518. doi: 10.1101/2025.03.25.25324518.

    PMID: 40365444DERIVED

MeSH Terms

Conditions

Infertility, MaleNeoplasmsAutoimmune Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital DiseasesImmune System Diseases

Study Officials

  • Kyle E Orwig, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer L Anglin

CONTACT

412-641-7475fertilitypreservation@upmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 18, 2020

First Posted

June 30, 2020

Study Start

November 10, 2023

Primary Completion (Estimated)

December 28, 2029

Study Completion (Estimated)

May 31, 2030

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

The investigators will publish individual participant data, after deidentification. The investigators will also report each individual participants data back to them. Participants will be identified with unique ID numbers. No identifiable information will be shared.

Shared Documents
STUDY PROTOCOL
Time Frame
Beginning 9 months and ending 36 months following article publication.
Access Criteria
Researchers who provide a methodologically sound proposal. Proposals should be directed at korwig@mwri.magee.edu

Locations

US(1)