Critical appraisal:Ginsberg JP, Li Y, Carlson CA, Gracia CR, Hobbie WL, Miller VA, et al 2014

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Article
Ginsberg JP, Li Y, Carlson CA, Gracia CR, Hobbie WL, Miller VA, et al. Testicular tissue cryopreservation in prepubertal male children: an analysis of parental decision-making. Pediatr Blood Cancer 2014 Sep;61(9):1673-8 Available from: http://www.ncbi.nlm.nih.gov/pubmed/24777742.
Assigned to
User:Rita.upreti
Topic area
Guidelines:COSA:Cancer fertility preservation guidelines/Options for treatment
Clinical question
Form
Form:Critical appraisal


Section below only relevant for Cancer Council Project Officer

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Critical Appraisal

Article being appraised

Ginsberg JP, Li Y, Carlson CA, Gracia CR, Hobbie WL, Miller VA, et al. Testicular tissue cryopreservation in prepubertal male children: an analysis of parental decision-making. Pediatr Blood Cancer 2014 Sep;61(9):1673-8 Available from: http://www.ncbi.nlm.nih.gov/pubmed/24777742.


Applicable clinical question

Key Facts

Study Design

case series

Study aims:

To access the acceptability and safety of a multi-institutional protocol for offering testicular tissue cryopreservation to families of prepubertal male children at highest risk for infertility

Number of Patients:

42

74 prepubertal males identified: 57 families (77%) consented to testicular biopsy; 48 underwent the procedure.-- 42 of these patients had cancer

Cancer subtypes were: high risk neuroblastoma, rhabdomyosarcoma, osteosarcoma, Ewing sarcoma or sarcoma not otherwise specified

6 of 48 did not have malignancies, therefore these patients have been excluded from the 42 listed above.
Reported outcome(s):

Prepubertal males facing gonadotoxic therapy were offered testicular cryopreservation.
There is no data regarding pregnancy or live birth rates.
Post-biopsy, patients were followed for acute side effects - excessive pain, bleeding, or infection, both intra-operatively and post operatively for a period of 1 week.
In addition, parents and patients were asked to complete questionnaires including demographics and factors influencing a family’s decision to cryopreserve or not.

Results of outcome(s):

Testicular biopsies were successfully obtained on all 48 male children with no intra- operative adverse events. Testicular biopsy was performed by an urologist during a procedure when the patient was already under general anaesthesia for their clinical care.
There was one postoperative scrotal cellulitis in a 17-month-old who was being transplanted for an immunodeficiency.
There were no other post-operative infections, and no bleeding issues.
Post-biopsy there were no reports of excessive pain documented.

Comments on results:

The main conclusion was not related to our question: 'The high acceptance rate (77%) of this multi-institutional research option affirms that families are willing to undergo the testicular biopsy procedure for tissue cryopreservation, even when there are no guarantees that the science will exist in the future to allow their sons to use this banked tissue to achieve pregnancy'

Includes an economic evaluation

no

Evidence ratings

Level of evidence

IV

Risk of bias
High risk of bias Comments:


Size of effect
5 Reason for decision:
Relevance of evidence
1 Additional comments: Directly assesses relevant short term side effects of intervention, but only to one week post-operatively.
Result of appraisal

Jutta's tick icon.png Included



Comments

This study supports the lack of short term adverse outcome from testis biopsy for sperm cryopreservation. This study does not address whether this technique is effective for later fertility treatment.

Completed by

Dr Jessica Harris