Critical appraisal:Ginsberg JP, Carlson CA, Lin K, Hobbie WL, Wigo E, Wu X, et al 2010

This appraisal has been completed.

Article

Ginsberg JP, Carlson CA, Lin K, Hobbie WL, Wigo E, Wu X, et al. An experimental protocol for fertility preservation in prepubertal boys recently diagnosed with cancer: a report of acceptability and safety. Hum Reprod 2010 Jan;25(1):37-41 Available from: http://www.ncbi.nlm.nih.gov/pubmed/19861330.

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

Ginsberg JP, Carlson CA, Lin K, Hobbie WL, Wigo E, Wu X, et al. An experimental protocol for fertility preservation in prepubertal boys recently diagnosed with cancer: a report of acceptability and safety. Hum Reprod 2010 Jan;25(1):37-41 Available from: http://www.ncbi.nlm.nih.gov/pubmed/19861330.

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:

This pilot study describes a research protocol for testicular tissue acquisition and distribution.

Number of Patients:

14

Families of prepubertal boys newly diagnosed with Stage IV neuroblastoma,rhabdomyosarcoma, osteosarcoma or Ewing sarcoma were offered the opportunity for testicular biopsy/cryopreservation. The therapy would be highly gonadotoxic. Pubertal who attempted to bank sperm but failed were also eligible for this study.

N= 21 eligible (median age of 5 years, range 3 months to 14 years) approached
N= 16 families consented to the testicular biopsy (76%).

N= 14 of the 16 actually underwent testicular biopsy ( 2 did not proceed to biopsy because the frozen tumour biopsy was not consistent with malignancy)

Reported outcome(s):

Aspects of the consenting process, sample processing and safety outcomes considered

Results of outcome(s):

The only comment is:
"From a safety perspective, there have been no acute adverse effects of the testicular biopsy, and this procedure is well tolerated"

Comments on results:

Note there is just one line about safety in the discussion i.e. no defined endpoints pertinent to the specific question we ask

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

5	Additional comments:

Result of appraisal

Included

Comments

This study does not address the first part of the question and is only included as (on brief mention) it addresses the second question and shows no evidence of harm from the harvesting procedure

Completed by

Dr Jessica Harris