Condition category
Urological and Genital Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
13/03/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr P Mahendra

ORCID ID

Contact details

Clinical Haematology
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0265055944

Study information

Scientific title

Acronym

Study hypothesis

1. To examine whether chemotherapy/radiotherapy induced azoospermia/severe oligozoospermia can be reduced or prevented by 'down-regulation' of the pituitary using GnRH agonists.
2. If partial or complete gonadal protection is conferred by GnRH, will the sperm subsequently produced be damaged genetically?
3. If previously impaired sperm production in (due to the nature of the malignancy) improve post protective treatment with GnRHA?
4. To examine the effects of chemotherapeutic agents on sperm nuclear and mitochondrial DNA and the induction of apoptosis.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Not Specified

Patient information sheet

Condition

Urological and Genital Diseases

Intervention

The investigations will comprise the following:

Sperm Storage
Immediately on referral, patients will be given the opportunity to have spermatozoa cryopreserved at the ACU, Birmingham Women's Hospital. Briefly, after a full semen analysis (see below) and completion of relevant documentation, an equal amount of cryoprotectant media is added to the semen over a period of 10-15 minutes. Vials are then suspended in liquid nitrogen vapour.

Semen Analysis
Full semen analysis, including sperm concentration; motility; morphology; antisperm antibodies. vitality are carried out in accordance with the World Health organisation (WHO, 1992). Computer assisted sperm motility analysis (CASA) will also be performed, using an Hamilton Thorn IVOS (version 8.1).(Tomlinson Ct al, 1993).

Blood tests
Bloods for serum FSH and testosterone will be taken at the time of semen analyses.
Sperm nuclear DNA (nDNA) and mitochondrial DNA (mtDNA)
Sperm nuclear DNA Damage will be assessed using the TUNEL assay or using the sperm nuclear
cliromatin integrity analysed using the Chromomycin A3 fluorochrome (Manicardi et al, 1995; 1998) Mitochondrial DNA fragmentation will be studied using long PCR according to the methods of St.John, (in press).

Mitochondrial Function
Mitochondrial membrane potential will be assessed using the fluorescent probe D1Oc6 counterstained with propidium iodide for sperm viability according to the methods Zamzami et al (1996).

Samples
Samples will be assessed immediately after referral from the oncology centres. A second sample will be assessed 3 months later and then again at 6 months.

All the above mentioned techniques have been developed and validated and are in current use in our laboratories.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/2003

Overall trial end date

01/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Patients will be referred from tertiary referral centres in Birmingham. These will include principally the Queen Elizabeth Hospital in Edgbaston, Selly Oak Hospital and the Dept of Haematology, Heartlands Hospital. They will have been referred for sperm storage to prior to chemo or radiotherapy mainly in cases of malignant disease but also in other conditions e.g. treatment of nephrotic syndrome. Patients will be randomised to treatment groups at the point of intention to treat.

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/10/2003

Recruitment end date

01/01/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical Haematology
Birmingham
B15 2TH
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

University Hospital Birmingham NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Research Funds

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes