Critical appraisal:Babayev SN, Arslan E, Kogan S, Moy F, Oktay K 2013

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Article
Babayev SN, Arslan E, Kogan S, Moy F, Oktay K. Evaluation of ovarian and testicular tissue cryopreservation in children undergoing gonadotoxic therapies. J Assist Reprod Genet 2013 Jan;30(1):3-9 Available from: http://www.ncbi.nlm.nih.gov/pubmed/23242649.
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

Babayev SN, Arslan E, Kogan S, Moy F, Oktay K. Evaluation of ovarian and testicular tissue cryopreservation in children undergoing gonadotoxic therapies. J Assist Reprod Genet 2013 Jan;30(1):3-9 Available from: http://www.ncbi.nlm.nih.gov/pubmed/23242649.


Applicable clinical question

Key Facts

Study Design

case series

Study aims:

To investigate the short term safety of unilateral testis biopsy in male children with cancer and haematological disorders about to receive gonadotoxic therapies.

Number of Patients:

4

N=9 had surgery (aged 1-12.8 years)
N=4 of these had cancer
Reported outcome(s):

Blood loss, operative and anaesthetic times and surgery adverse events.
There were no data on subsequent fertility, reproductive or other aspects ofhealth
No data on histology. Most of the biopsy was just frozen

Results of outcome(s):

Minimal blood loss.
No complications during hospitalisation.

Comments on results:

Readily acknowledge that testis biopsy for stem cell cryopreservation and later use by patient is experimental.
There is no data on such use so success cannot be guaranteed
Spoke of the strategic bundling of medically indicated procedures (eg insertion of IV catheters for later treatment use) with gonadal tissue harvesting can potentially reduce risks, cost, and inconvenience.

Includes an economic evaluation

no

Evidence ratings

Level of evidence

IV

Risk of bias
High risk of bias Comments: The numbers are very small.

There is no statement about how many parents were approached and declined to have biopsy/storage, thus there is a risk of selection bias though it does not appear this information would in any way affect the very limited scope of safety endpoints.


Size of effect
5 Reason for decision:
Relevance of evidence
5 Additional comments:
Result of appraisal

Jutta's tick icon.png Included



Comments

This study evaluates the collection not use of cryopreserved testicular tissue - it is included only as it addressed consequences of the harvesting procedure (second part of the question)

Completed by

Professor Robert McLachlan AM FRACP PhD