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SpermCheck®FERTILITY Self-test

Available in pharmacies or online :   

Over 1 out of 5 couples1 experience infertility.

 In 1 out of 2 of those couples, the man is concerned. 

Infertility is the failure to get pregnant after one year in a couple engaging in regular unprotected sexual intercourse without a contraceptive method.

 

The FERTILITY Self-Test can effectively detect an insufficient sperm count in a semen sample.

  • Can be performed in the privacy of your own home

  • Easy to use

  • More than 98% reliable compared with laboratory tests

  • Based on specific detection of the sperm protein SP10

  • Easy-to-read results in 7 minutes

1 InVS, BEH n°7-8-9 (february 21th, 2012).

Who is it for ?

The SpermCheck® FERTILITY Self-Test is for men/couples trying to conceive who want quick reliable information about their fertility.

In France, more than 1 out of 10 couples see a doctor for difficulties in conceiving a child1. The clinical diagnosis finds disorders in the woman in half of those cases, and in the man in the other half.

Women are no longer considered solely responsible for fertility problems. Male infertility is the cause in 1 case out of 22.

The SpermCheck® FERTILITY Self-Test is a first source of information for couples experiencing difficulty in conceiving.

F. Marcelli, G. Robin, J-M. Rigot. Prise en charge de l’infertilité masculine. Prog. Urol.2009 02;19 (4): 260-264.  

2 Schlegel PN. Evaluation of male infertility. Minerva Ginecol. 2009 Aug;61(4):261-283.

 

Why ?

More than 1 out of 5 couples in France experience (temporary or permanent) infertility1.

It involves men as often as women. A male factor is involved in 50% of fertility problems.

One out of 20 men suffer from subfertility2.

The main cause identified is a low sperm count3. Moreover, sperm counts have fallen by 30% in the past 16 years. 


A low sperm count can be detected in laboratory semen analyses. However, a trip to the doctor for this type of problem is often embarrassing and difficult for men. Subfertility is often confused with a lack of virility. 

The SpermCheck® FERTILITY Self-Test is easy to use and confidential for men/couples hesitating to see a doctor first.

The SpermCheck® FERTILITY Self-Test is accurate over 98% of the time*, which makes it the perfect solution for quickly and effectively detecting a low sperm count. 

The SpermCheck® FERTILITY Self-Test increases the awareness of men about their potential infertility and helps couples continue seeking additional laboratory tests and medical help for conception if necessary.
 

(1) InVS, BEH n°7-8-9 (21 février 2012).
(2) Hirsch A. ABC of subfertility: Male subfertility. BMJ 2003; 327:669.672
(3) Le Moal J. Semen quality trends in French regions are consistent with a global change in environmental exposure. Reproduction 2014 ; 147 (4) : 567-574. 

*A study conducted between January and April 2014 in a medically-assisted procreation centre in 200 healthy men of child-fathering age showed that more than 98% of the results obtained with the SpermCheck® FERTILITY Self-Test matched those of the reference technique used in laboratories: the semen analysis.


How ?

 

1 - Recueil de l’échantillon de sperme

 

2 - Prélèvement de l’échantillon de sperme liquéfié

 

3 - Transfert de l’échantillon dans la solution SpermCheck®

 

4 - Mélange de l’échantillon de sperme avec la solution SpermCheck®

 

5 - Dépôt de l’échantillon

 

6 - autotest Fertilité négatif

 

7 - autotest Fertilité positif

 

1 - Recueil de l’échantillon de sperme

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The SpermCheck®FERTILITY Self-Test is an immunochromatographic test.

The SpermCheck®FERTILITY Self-Test detects the presence in a semen sample of the SP10 protein found on the head (acrosome) of sperm cells when the sperm count is over 15 million spermatozoa per millilitre (spz/ml).

Figure of a sperm cell
 

This threshold of 15 million spz/ml is the reference level of the World Health Organization, and corresponds to the count over which 95% of men are able to successfully conceive a child with their partner within a period of one year.

 

The SpermCheck® FERTILITY Self-Test uses this "standard" to detect a normal sperm count (greater than or equal to 15 million spz/ml) or a low sperm count (below 15 million spz/ml).
 

This means that the SpermCheck® FERTILITY Self-Test is a rapid screening test for an insufficient sperm count.  

The SpermCheck® FERTILITY Self-Test  is sold in France in all pharmacies. 

The SpermCheck® FERTILITY Self-Test can be performed at home. 

 Each SpermCheck® FERTILITY Self-Test box contains everything needed for the test :

  • illustrated instructions to help you perform the test
  • a semen collection kit
  • a SpermCheck® solution for preparing the sample
  • a device to detect a normal or low sperm count


SpermCheck® results are easy to obtain and interpret. The results can be read after 7 minutes as one or more reddish test lines.


Characteristics and performance

Packaging : unit kit
Storage : 2 to 30°C
Sample type : semen
Reliability : 98%* compared with laboratory tests

 

*A study conducted between January and April 2014 in a medically-assisted procreation centre in 200 healthy men of child-fathering age showed that more than 98% of the results obtained with the SpermCheck® FERTILITY Self-Test matched those of the reference technique used in laboratories: the semen analysis.

 

A - 1 SpermCheck® device (in a sealed pouch)
B - 1 semen collection cup
C - 1 semen transfer device
D - 1 SpermCheck® solution bottle
E - 1 kit package leaflet


FAQs

 
SpermCheck® FERTILITY Self-Test Kit

Why should I use the SpermCheck® FERTILITY Self-Test ?

The SpermCheck® FERTILITY Self-Test is the first CE marked immunological male fertility self-test. It has been the subject of several prior studies demonstrating that it reliably identifies a low semen sperm count.

The test is quick and easy to perform at home and gives men and couples trying to conceive a first source of information about their fertility.

What does the SpermCheck® FERTILITY Self-Test do ?

How accurate is the SpermCheck® FERTILITY Self-Test ?

Where can I buy the SpermCheck® FERTILITY Self-Test ?

I just bought my SpermCheck® FERTILITY Self-Test. Do I need anything else ?

Is there an optimal time to perform my SpermCheck® FERTILITY Self-Test ?

Can I use my SpermCheck® FERTILITY Self-Test more than once ?

What are the technical characteristics of the test ?


How to perform the FERTILITY Self-Test

After waiting 20 minutes, my semen sample has still not liquefied. What should I do ?

What handling precautions should I take when performing my test ?

Why is it important to read the results of the self-test exactly 7 minutes after adding the 6 drops ?

Reading and interpreting the results

According to the SpermCheck® FERTILITY Self-Test, what does a "normal" sperm count mean ?

According to the SpermCheck® FERTILITY Self-Test, what does a "low" sperm count mean ?

My SpermCheck® FERTILITY Self-Test is positive. Am I fertile ?

My SpermCheck® FERTILITY Self-Test is negative. Am I infertile ?

If my SpermCheck® FERTILITY Self-Test is negative, what should I do?

Are there diseases or medications that could change my SpermCheck® FERTILITY Self-Test results ?

What factors may affect my sperm count ?

Warnings

For in vitro diagnostic use.

 

Do not swallow.

 

Store in a dry place between 2 and 30°C, away from sunlight. DO NOT FREEZE.

 

Read all of the instructions carefully before starting the test.

 

Do not use after the expiry date printed on the package.

 

Keep out of reach of children.

 

Do not use this test as a contraceptive method.

 

This test does not protect against sexually-transmitted diseases.

 

This test cannot be used as a paternity test.

 

Poor vision and/or insufficient lighting could prevent correct interpretation of the results.

 

This test is for single use only. DO NOT RE-USE.

 

This test is only intended for measurement of the sperm count. It does not detect all fertility-related problems

Legal disclosures

The SpermCheck® FERTILITY Self-Test (ref. SCF-001FR) is a male fertility test manufactured by Princeton BioMeditch Corporation, and distributed exclusively by AAZ-LMB France. It is intended solely for the evaluation of the sperm count in a freshly collected semen sample. When in doubt regarding the result obtained, consult your doctor. This in vitro diagnostic medical device is a regulated healthcare product that is CE marked as required. Read the package leaflet carefully and ask your pharmacist for advice. A positive SpermCheck® Fertility test alone does not prove that you are fertile, as other factors also affect a man's ability to procreate. If you and your partner have been trying to conceive without success for several months, you should have a complete laboratory semen analysis done, even if you get a positive result from the SpermCheck® test. Internal reference no.: AAZ.AF.01-A (updated on 27 July 2015).

VISA no. 15/07/AAZASAN/GP/002