Fertility Preservation in Prepubertal Boys: An Experimental Approach

NCT02529826 | Unknown DMC

• 1 other identifier: 0530-14-HMO
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Due to remarkable advances in cancer treatments, the investigators are witnessing a growing population of long-term survivors of childhood malignancies. However, fertility in adult life may be severely impaired by gonadotoxic therapies. Since prepubertal boys cannot produce spermatozoa, banking of testicular tissue prior to gonadotoxic treatment is a crucial step towards fertility preservation for this population. Several centers around the world are now cryopreserving testicular tissue for prepubertal boys in anticipation that future technologies will allow the utilization of the banked samples for fertility restoration. Testicular tissue cryopreservation has now emerged as the leading strategy for fertility preservation in prepubertal boys before gonadotoxic treatments. Fertility restoration can theoretically be obtained after allo-transplantation of testicular tissue fragments that preserve both the SSCs and the supporting microenvironment (spermatogonial stem-cell niche).

Conditions

Oncology [See Also, Affected System]

Keywords

Cancer-affected prepubertal boys

Outcome Measures

Primary Outcomes (1)

• Number of cancer affected prepubertal boys who will undergo testicular cryopreservation for fertility restoration.

  The investigators will report the number of cancer affected prepubertal boys that will undergo testicular cryopreservation for future fertility restoration.

  The time frame for this study is defined from the date of recruitment until the date of clinical utilization of the cryopreserved tissue for fertility restoration, up to forty years

Study Arms (1)

Testicular biopsy

EXPERIMENTAL

Cancer affected prepubertal boys will undergo testicular biopsy for testicular fragments cryopreservation. The biopsy will be performed by an attending urologist, before any gonadotoxic therapy is initiated. Testicular biopsy specimens will be divided immediately on the operating table. Two thirds of the specimen will be cryopreserved for potential use by the patient at a later date and will have the patient's details and will stay at the sperm bank of Hadassah Medical Center. The other third of specimen will be used for research purposes in an effort to advance the science of isolating and culturing human SSC's for fertility research.

Procedure: Testicular Biopsy

Interventions

Testicular Biopsy PROCEDURE

An open testicular biopsy will be performed by an attending urologist under general anesthesia.

Testicular biopsy

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Prepubertal males newly diagnosed with high risk malignancy (not testicular), and whose treatment will include therapy with agents that place the boy at high risk for infertility are also eligible.

You may not qualify if:

• None

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

Related Publications (1)

• Kabiri D, Safrai M, Gropp M, Hidas G, Mordechai-Daniel T, Meir K, Revel A, Imbar T, Reubinoff B. Establishment of a controlled slow freezing-based approach for experimental clinical cryopreservation of human prepubertal testicular tissues. F S Rep. 2021 Nov 5;3(1):47-56. doi: 10.1016/j.xfre.2021.11.001. eCollection 2022 Mar.

  PMID: 35386499 DERIVED

Study Officials

• Doron Kabiri, MD

  Hadassah Hebrew Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2015
• First Posted: August 20, 2015
• Study Start: November 1, 2015
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: August 20, 2015

Record last verified: 2015-04

Locations

IL (1)