SpermComet - Lab Information

Lab Information

The human desire to have children is at heart of our

being. If couples find it hard to get pregnant, it can be one of

the most distressing times of their lives

We offer unique testing for male fertility

Dear Colleagues,

Thank you for your interest in the SpermComet® Test.

At Lewis Fertility Testing we aim to provide our partner clinics and healthcare professionals

with a professional and efficient service. Most importantly, in this emotional journey for

patients in which time is of the essence, we promise to have patient results returned to the

referring clinician within 7 days of sample receipt.

Please find enclosed the necessary documents that will enable you to begin sending patient

samples for the SpermComet® Test. All relevant information for patients has also been sent

to you and we would ask that you give this e-information to patients before their

appointment.

For matters relating to the laboratory and testing procedures, please contact Laboratory

staff, Lynsey Poots or Marty Lawlor;

Email: lab@lewisfertilitytesting.com

Telephone: 02890238915 .

For business matters, please contact Marketing Manager, Orla Hardy;

Email: orla.hardy@lewisfertilitytesting.com Telephone: 02890238915.

With kind regards,

Sheena E M Lewis

Managing Director, Lewis Fertility Testing Ltd

Lab protocol

Sending Samples to Lewis Fertility Testing

At Lewis Fertility Testing, we aim to make the process of sending samples for analysis with the

SpermComet® Test as smooth as possible. We work with respected World Class couriers, who

promptly transport precious samples to our laboratory from fertility clinics all over the World.

 When you have samples ready for collection, please send an email to

lab@lewisfertilitytesting.com , and we will arrange for a charged dry shipper to be sent to

your clinic.

 When the shipper arrives at your clinic, it will be fully charged and can hold cryogenic

temperatures for a further 10 days.

 We will agree a designated pick-up day with you and Lewis Fertility Testing couriers will call

back to your clinic and collect the dry shipper, with the patient samples inside.

 Please also attach a completed Test Request Form for every patient sample that is to be

tested. A paper hardcopy can be enclosed in the shipper or a scanned electronic copy can

be sent to lab@lewisfertilitytesting.com .

 Upon receiving the patient samples, Lewis Fertility Testing will have results emailed to you

as soon as the samples are processed; a maximum of seven days.

Sample Freezing Protocol for the SpermComet® Test

Ejaculated sperm freezing protocol

1) Before handling the dry shipper please ensure you wear correct PPE

2) You shall receive the dry shipper which is contained in a mushroom shaped shipping

container

3) There is no requirement for you to remove the dry shipper from its mushroom

container

4) Please label cryovials (two per patient) with patient forename, surname, DOB and

your clinic ID

5) All semen samples should be liquefied for at least 30 minutes (up to 60mins) after

ejaculation, which is done by leaving the sample in the sample pot at room

temperature and in the dark.

6) For Cryovials - Add 100µl of semen sample / 200µl of testicular biopsy sample into

each of two cryovials. (For patients with oligozoospermia a volume containing a

minimum of 5000 sperm).

7) For Freezing Straws - Add 100µl of semen sample / 200µl of testicular biopsy sample

into each of two 1.5ml eppendorfs. (For patients with oligozoospermia a volume

containing a minimum of 5000 sperm). Suck each aliquot into a freezing straw and

seal according to the manufacturer’s instructions.

8) Once samples have been added to the shipper, please ensure that the foam cork/lid

is securely placed on the shipper for return to LFT. Failure to do so will result in

temperature failure and loss of the samples.

9) Once samples are loaded, close mushroom container and fasten shut. Place

container at agreed pickup point and the LFT couriers will collect at the agreed time.

Surgically retrieved sperm protocol

1) Please label cryovials (two per patient) with patient forename, surname, DOB and

your clinic ID

2) All surgically retrieved sperm should be mixed with the cryoprotectant

SpermFreeze™.

3) Add 0.7ml of SpermFreeze™ to 1ml of surgically retrieved sperm. Do so by added

SpermFreeze™ drop by drop, being carefully to ensure there are no air bubbles.

4) Allow cryoprotectant and sample to equilibrate at room temperature for 10mins

5) Plunge cryovials into liquid nitrogen to snap freeze and store at -196°C until

transport to LFT

6) Once samples have been added to the shipper, please ensure that the foam cork/lid

is securely placed on the shipper for return to LFT. Failure to do so will result in

temperature failure and loss of the samples.

7) Once samples are loaded, close mushroom container and fasten shut. Place

container at agreed pickup point and the LFT couriers will collect at the agreed time.

FORM 1 SpermComet™ Test Request Form to be completed by referring clinic and emailed to lab@lewisfertilitytesting.com

Referring Clinician/GP/Healthcare Professional (if applicable) Address

Patient Name

Address

Email

Tel. Number

DOB and Age

Smoker (yes/no) Number/day

Medication

Dietary supplements

Occupation

Sample Information

Date of sample collection

Abstinence time (days)

For LFT use

Ejaculate or Surgically Retrieved Sperm

Sperm Count

Normal / Abnormal

Semen Analysis

Comments

Previous ART Treatments ( if any )

Treatment

Outcome

IUI / IVF / ICSI

Date

Fertilization

Clinical Pregnancy

Live Birth

Disclaimer for Individual Couples: The information given by this test is not intended to provide professional medical advice. The test does not indicate conclusively that you infertile or incapable of achieving a pregnancy naturally. Normal full-term pregnancies are still possible with higher levels of DNA damage although DNA damaged sperm are associated with a greater number of miscarriages. The proprietors of this test can provide you with information upon which to make an informed decision but they cannot guarantee that a successful pregnancy will result from any treatment, which you choose. The test gives information as to those treatments which have the highest level of success potential for a successful pregnancy with sperm DNA damage. Both partners can contribute to a couples’ infertility. The usefulness of any test for one partner is dependent of the fertility of the other partner too. You should consult with your clinician/ doctor about these results in the overall picture of your infertility diagnosis and treatment options for you and your partner. This test has been shown to perform successfully in the groups published in peer reviewed scientific literature, but it is still under performance evaluation in larger populations. You are participating in the ongoing performance evaluation when undertaking this test. I have read and understood this disclaimer

Signed:

Date:

For Lewis Fertility Testing Use

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