ESHRE, The European Society of Human Reproduction and Embryology is a non-profit organization.
ESHRE was founded in order to encourage and recognize study and research in the field of reproduction and is a lead independent Europian authority in ART.
The aims of the society is to promote the understanding of reproductive biology and embryology, to facilitate research and the subsequent dissemination of research findings to the public, scientists, clinicians and patient associations and to inform politicians and policy makers in Europe. The society further engages in medical education activities, the development of data registries, and the implementation of methods to improve safety and quality in clinical and laboratory procedures.
Education has always been a priority for the European Society of Human Reproduction and Embryology. Many efforts have been dedicated to promoting knowledge of techniques, procedures and strategies in order to ensure use of the highest quality practices in reproductive medicine.
WHAT ARE THE BASICS OF GOOD LABORATORY PRACTISE BEST IVF CLINICS APPLY AND COMPLY WITH?
The embryologist is responsible for the correct and justified application of ART. Implementing a quality control system for IVF laboratory, the strict compliance of procedures and further development of the system benefits all patients attending IVF clinics.
Top IVF laboratories are led by an appropriately qualified and experienced scientist or medical doctor according to national rules. There are appropriate numbers of staff with the required experience and on-going medical education.
POLICIES AND PROCEDURES
All laboratory procedures must include provision for unique patient identification whilst retaining patient confidentiality.
Laboratory results interpretation should be accurate, comprehensive and clinically relevant. There is a written, signed and dated protocol for every procedure, written transmission of results and regular maintenance of equipment.
The embryology laboratory should have adequate space to follow good laboratory practice and should ensure aseptic and optimal handling of gametes and pre-embryos during all phases of the treatment.
The laboratory equipment used should be adequate for laboratory work and easy to clean and disinfect. Critical items of equipment, including incubators and frozen embryo storage facilities, should be appropriately alarmed and monitored.
THE SAFETY
Procedures and policies for the safety of personnel should be establish, taking national and/or local safety regulations into consideration such as vaccination of the personnel against hepatitis B or other viral disease. The laboratory staff must be always informed about the risks of handling potentially infected biological material.
PROTECTIVE MEASURES
The purpose of the protective measures is also to ensure aseptic conditions for gamete and embryos. The procedures should deal with, but not be limited to: use of laboratory clothing, use of non-toxic gloves and masks, use of eye and face protection if cryogenic materials are handled.
Material stored in the cryopreservation tanks should be kept in a way that avoids contact of the liquid nitrogen phase with the biological substances. Safety cryo straws have been conceived in order to fulfil this requirement.
CORRECT HANDLING AND IDENTIFICATION OF PATIENTS AND THEIR GAMETES AND EMBRYOS
Written procedures should be present describing the various phases of IVF techniques. Rules concerning the correct handling and identification of gametes and embryo samples should be established by a system of checks and, where needed, double-checks. Proper training of all the laboratory staff according to these procedures is mandatory. Modern clinics are using electronic witnessing systems for constant checking and recording.
Verification of patients' identity should be performed at all critical steps: before ovum retrieval, at semen recovery and embryo transfer procedures. Double checks need to be considered at least at: insemination of oocytes, replacement of embryos, embryo freezing and thawing.
The laboratory procedures regarding the handling of gametes for assisted reproduction techniques have been standardized to a large extent. The procedures should be easy, simple and effective. Procedures should be in place which ensure correct patient identification at all stages. Labelling of dishes/tubes containing oocytes, embryos, or spermatozoa should be permanent. At each stage of the procedure the identity of the embryologist should be recorded.
EMBRYO CULTURE AND EMBRYO TRANSFER
The scoring of embryos at regular intervals provides the possibility to the embryologist of tracking embryo development. Embryos can be grown to day 5 or 6 for a transfer at the blastocyst stage. Sequential allow the growth of blastocysts with a high implantation rate.
In some countries the maximum number of embryos transferred is established by the local legislation. As a general recommendation, it is advisable not to exceed two. When blastocysts are available, the number of blastocysts transferred should be limited to two. The supernumerary embryos may be cryopreserved, donated to research or discarded, according to the couple's wishes and to the national legislation.
CRYOPRESERVATION OF EMBRYOS
Embryo freezing can be performed at different stages: zygotes, embryos in early cleavage (day 2 or day 3), blastocysts. Embryos displaying a high degree of fragmentation or very slow or blocked cleavage rate should be discarded from storage procedures due to the low survival rate reported after thawing.
In some countries, the application of cryopreservation procedures is regulated by law.
Cryopreservation of embryos should be available in each IVF centre to: cryopresere spare embryos after transfer, cryopreserve because of delaying embryo transfer in a subsequent cycle if the patient becomes ill or develops ovarian hyperstimulation syndrome (OHSS); storing the embryos generated from donated oocytes in order to allow a 6 month quarantine so that the potential donors may be controlled for infectious diseases prior to embryo transfer.
QUALITY CONTROL USING EVALUATION OF RESULTS
Results should be evaluated on a regular basis. In order to prevent bias due to patient variation for the purpose of quality control, a group should be selected where certain criteria can be established. The following should be regularly analysed:
- fertilization rates;
- embryo quality;
- pregnancy rates;
- multiple pregnancy rates;
- implantation rates.
FUTURE PROSPECTS
Novel techniques have been proposed during the last few years aimed at expanding ART indications: freezing of oocytes and ovaries, in-vitro maturation of oocytes, intracytoplasmic transfer, spermatid injection, embryo implantation. Reports continue to accumulate from animal studies and preliminary data. However, additional studies are necessary before admitting these procedures to the standard technique protocols which are routinely performed in IVF laboratories.
Source: ESHRE guidelines for good practice in IVF laboratories
