Sperm Bank
Gametia sperm bank guarantees a high quality standard for all our samples, being consistent through the automatization of the processes. A wide variety of phenotypes is presented in the following types of straws:
Description
0.5 ml straw containing more than 8 million of spermatozoa with progressive motility/ml
Concentration
MOT 8+
Indicated Use
IUI, ICSI
Pre-freezing process
Semen sample is processed by density gradients technique, and after washing it is diluted (1 + 3) with Sperm Freeze.
Processing of the sample before use
It is recommended to wash the sample in order to eliminate the
cryoprotectants
Description
3 straws of 0.5 ml/straw containing more than 10 million of spermatozoa with progressive motility/ml
Concentration
MOT 10+
Indicated Use
IUI, IVF, ICSI
Pre-freezing process
The ejaculate is diluted (1+1) with Freezing Medium – TEST yolk buffer.
Processing of the sample before use
Sperm preparation will be done in order to eliminate seminal plasma,
cryoprotectants, immotile sperm and round cell.
Donor recruitment
Thanks to our network of fully owned centres we can count on a wide phenotype diversity and different service options. Every month over a 100 new male donors join our programmes.
But at Gametia Biobank we believe that the more demanding we are, the greater security we offer to patients and clinics.
This is the reason why our DONOR SELECTION PROCESS is much more demanding than what is is required by local and EU regulations.
Less than 10% of the male candidates are accepted into our program. We continuously expand and update our Donor Screening following the recommendations of scientific societies such as ESHRE, ASRM, SEF, SIRU, ASEBIR, SIERR; and some other relevant international scientific societies. We are active consulting members in some of these societies.
- Candidates complete an online donor application
- Qualification requirements:
Chromosome study – Karyotype:
Only those donor candidates with a normal karyotype are accepted. In addition, donor candidates with polymorphic karyotype variants are ruled out, as they present worse results in assisted human reproduction.
Genetics
Latest advances in genetics are spectacular, and although there is still much to understand, we are able to deliver state of the art procedures to enable a dramatic reduction in the genetic risks associated to human reproduction.
For this reason, we carry out a Next Generation Sequencing (NGS) to detect the presence of genetic variants related to autosomal recessive and X-linked inheritance disorders of the donors.
Our screening significantly reduces the risk of the most common hereditary autosomal recessive diseases, however to enhance the genetic protection we offer an advanced genetic matching option.
And in case of very rare diseases that are present in the patients familiar history we can perform specific monogenic research as we keep samples of the DNA of all our donors.
Scientific studies estimate that most healthy people, on average, are carriers of one or two mutations that can lead to severe genetic disorders in offspring. In most cases, carriers show no symptoms and have no known family history of the disorder. In order for the symptoms of recessive disorders to develop, it is necessary for the two copies of a gene inherited by an individual to be altered.
The aim of the test is to detect the presence of mutations in genes associated with autosomal recessive inheritance in gametes as well as mutations in genes linked to the X chromosome in women. If both reproductive partners are carriers of pathogenic variants in the same gene associated with autosomal recessive inheritance, there will be an increased risk (25%) of having a child affected with that specific disorder. If a woman is a carrier of an X-linked disorder, (50%) of her sons would be at risk of being affected with that specific disorder.
Recipient patients who have carried out a carrier study for Recessive Monogenic Diseases and wish to reduce the risk of genetic diseases in their offspring can perform “genetic matching”. The result of this test is compared with the genetic study performed on our donors, selecting an ideal donor, in such a way that the donor and the recipient woman/man do not coincide in pathogenic variants in the same genes.
The test is recommended in assisted reproductive treatment but is also clinically valid in natural reproduction.
Sperm processing
AUTOMATION AND QUALITY: CE MARKED MEDIA AND DEVICES.
AUTOMATIC FILLING, FREEZING AND SEALING
We use automatic filling and heat sealing (CBS) equipment.- By automating the process we reduce the need to manipulate the sample, eliminating the possibility of contamination and errors in this part of the process.
- Robotic fillers guarantee homogeneity and consistency of straw filling.
- Automatic heat-sealing, thus prevents the possibility of contamination between samples due to breakage of the closure system, a problem inherent to the manual sealing of traditional straws and cryotubes.
COMPUTER CONTROL FREEZER MACHINE
Our freezing process is carried out with computerized Biofreezers, specific for sperm samples Consequently, Gametia achieves:- Optimization and homogeneity of results, by being able to reproduce the intensity and time of freezing.
- Decrease in the possibility of external contamination, typical of open freezing processes.
- Traceability of the temperature of the freezing process, and future access to all the individual freezing curves in case of need.
HIGH SECURITY STRAWS
In our freezing process we use high biological safety heat-sealable straws (CBS). The composition of these straws (resin type) gives them great flexibility, making them practically unbreakable and eliminating a significant problem of traditional straws. The impossibility of breakage and the fact that the straws are closed by heat sealing guarantees that the samples never comes into contact with liquid nitrogen thus reducing the risk of contamination to almost zero.CE MARKED MEDIA AND DEVICES
We use freezing media certified by the competent authority (CE marking) for use in humans. This leads us to comply with the most demanding recommendations issued by international organizations for human tissue and cell banks (European Directive 2004/23/EC and Spanish Law 9/2014). It ensures the traceability of this process, allowing us, in the event of an incident, to know the manufacturing batch and obtain information that identifies the problem. It guarantees the sterility of our freezing process.
Logistics
Transportation is a fundamental part of our activity, we take care of every last detail to guarantee a fast and safe delivery.
At Gametia we are experts in handling gametes and have access to different transportation options depending on the receiving centre preferences and individual requirements. We have shipped over 15.000 straws in 2021.
Cells travel in certified dry shipper containers which offer insulation and protection of the cells, and are protected by external shock resistant and leak proof cases built specifically for the transportation of biomaterials.
The dry Shipper is handled by an approved courier with authorisation to handle non dangerous biomaterial. Within the container, depending on requirements we can place a temperature control probe with a data logger that reports any fluctuation in the internal temperature. If needed also a tracking device can be added.
Delivery time 24-48h.
Dry Shippers autonomy: 120 hours
Recommended for all samples. Cells travel in a certified dry shipper container which offer insulation and protection of the cells, and are protected by external shock resistant and leak proof cases built specifically for the transportation of biomaterials.
This container is carried onboard by a trained and authorised courier that never looses sight of the package and delivers it directly to the receiving lab. Total traceability of the shipment is guaranteed by the courier operator. Within the container, depending on requirements we can place a temperature control probe with a data logger that reports any fluctuation in the internal temperature.
Delivery time 24-48h.
Dry Shippers autonomy: 120 hours
Recommended for all type of samples when distance allows. Cells travel in certified liquid nitrogen containers that are protected by external shock resistant and leak proof cases built specifically for the transportation of biomaterials.
The containers are loaded in specially equipped vans (ventilation, anti- knock over restraints… ) that is exclusively dedicated to the transport of our biomaterials.
The driver will deliver in hand the samples the receiving lab.
Within the container, depending on requirements we can place a temperature control probe with a data logger that reports any fluctuation in the internal temperature. If needed also a tracking device can be added.
Delivery time 1 to 5 days.
Liquid N2 Shippers autonomy: 10 days.
Irrespective of the chosen travel options the containers are sealed with a numbered fastener, anchored to the closure system. The identification number of the fastener is unique and is indicated in the shipping report.
Upon arrival of the samples the receiving lab staff should check the cases, contents, probes and documentation and if everything is correct sign the delivery.
What is it for?
The Single European Code is an identifier which supports traceability (the tracking of the whole process of cells from the donor to the recipient) and provide information on the main characteristics of such cells.
It allows the user to obtain information on the cells and the establishment associated with them, including the activities for which he is authorized and their contact details, essential information for the end users.
the SEC Code
What is it for?
The Single European Code is an identifier which supports traceability (the tracking of the whole process of cells from the donor to the recipient) and provide information on the main characteristics of such cells.
It allows the user to obtain information on the cells and the establishment associated with them, including the activities for which he is authorized and their contact details, essential information for the end users.
Single european code
and national registries.
All samples are codified and registered with a SEC code according to EU directives (2015/565) and local regulation. For example in the case of our Spanish biobanks the national SIRHA registry collects and manages the information of donors of gametes for reproductive purposes.
The SEC code makes easier the identification by the receiving Reproduction Center.
Donor transparency is one of the pillars of the legal framework and implies accessible and precise information about legal, ethical, and clinical aspects involving an effective control of new borns.
