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

This appraisal has been completed.

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

• In male cancer patients does the use of cryopreserved testicular tissue result in pregnancy and live birth? Is there any evidence of harm from the harvesting procedure?

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

• In male cancer patients does the use of cryopreserved testicular tissue result in pregnancy and live birth? Is there any evidence of harm from the harvesting procedure?

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

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