Medically assisted procreation: Updated rules of good clinical and biological practice

A decree updating the rules of good clinical and biological practice for medically assisted procreation (MPA) was published in the Journal Officiel on October 10, 2023. This text lays down a set of enforceable provisions to ensure better medical care for people undergoing all clinical and biological procedures for MPA, whether performed :

• intraconjugal or with a third-party donor,
• for gamete and embryo donation procedures
• as well as for the collection and preservation of gametes or germ tissue for fertility preservation purposes
• and for conservation for non-medical reasons.

The draft revision of these rules of good practice follows the new law of August 2, 2021 on bioethics and numerous medical and scientific advances, particularly in terms of infectious risks. It is the result of collaborative work led by the Agence de la biomédecine with professional representatives of learned societies, specialists in viral reproductive biology, virologists, a representative of the Haut Conseil de la santé publique and the Société Française d'Hygiène Hospitalière, and representatives of user associations, over the course of 2022.

In order to harmonize and streamline the MPA care pathway, this decree introduces the following main changes to the rules of good MPA practice:

• The removal of the requirement for dedicated laboratories to handle embryos, gametes and germ tissue from people with a known viral infection (particularly hepatitis B, C and HIV), due to :
• no known risk of cross-contamination in nitrogen storage tanks, subject to standard precautionary measures (Chapter I.10)
• no known risk of transmission via air and surfaces, subject to the application of standard precautions (Chapter I.10) to be established by the French Society of Hospital Hygiene (SF2H).
• A reduction in the number of medical biology tests required prior to MPA. As a consequence of the previous point, these tests are intended to reduce health risks for individuals, as in the general population (particularly in the pre-conception phase). They are repeated, as necessary, on the basis of medical criteria, but no longer systematically and compulsorily (Chapter II.5). The cases of gamete and embryo donors are described in chapters II.5.2 and II.5.3 respectively.
• The description of care paths for :- people undergoing MPA without (Chapter II.1) or with third-party donors (Chapter IV.1.1)

  • people who store their gametes for future use (non-medical storage) (Chapter III.3)

  • third-party donors of gametes and embryos (Chapter IV.2.1).

• The addition of an agreement between the insemination laboratory and the clinicians to whom it delivers sperm straws (Chapter I.3.2) and the reinforcement of provisions relating to the internal regulations of clinical-biological centers (CCB) (Chapter I.3.3).
• The creation of a chapter on the identification of persons, embryos, gametes and germ tissue (EGTG), which reinforces the measures to be implemented to reduce the risk of misattribution (Chapter I.5), and another on the organization of identification risk management (Chapter I.6.4).
• The possibility of carrying out more than 2 punctures (up to a limit of 4) for an oocyte donor, subject to a decision taken in multidisciplinary consultation and on a case-by-case basis (Chapter IV.1.4).

You will find the full decree in the downloadable attachment.