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This contribution aims at analysing and presenting a comparative dimension concerning the issues raised for the upcoming French Bioethics law revision in the field of assisted reproductive technologies (ART) : access of female same-sex couples and single women to ART ; the authorization of post-mortem procreation ; enlarging eligibility criteria for oocyte self-conservation ; and lifting the anonymity of gamete donation. These questions touch at the very heart of the French bioethics model conceived in 1994, and their revision would constitute a conceptual upheaval., (© 2019 médecine/sciences – Inserm.)

The validation of methods in medical biology is a fundamental step in which the laboratory defines its analytical objectives, characterizes the performance of the technique according to the level of quality it fixes and discusses the results obtained. The objective of this work is to contribute to respect the requirements of ISO 15189 in terms of performance verification of a manual qualitative technique of medically assisted procreation (PMA): morphological identification of the oocyte, the zygote and the embryo, harmonization of professional practices and assessment of competences by associating the bibliographic approach and above all by justifying its choices. Validation of PMA methods is difficult for reasons related to the mostly manual methods used in our context but also to the type of matrix i.e. the oocyte sampling which remains a valuable harvest. Due to the lack of internal quality control and external quality evaluation, risk control in the three pre-, post- and post-analytical stages becomes decisive, based on the 5M method, the establishment of coherent means of control adapted to its own practice, it also concerns the empowerment of staff through training, evaluation and monitoring of operators' performance.

Assisted Reproductive Technologies (ART) are authorized in France in couples infected by the human immunodeficiency virus (HIV) since the French legislation of May 10th, 2001. The goals are to reduce the risk of viral transmission between partners and to treat an underlying infertility. The classical techniques are used: IUI, IVF or ICSI, but all of them must be done in specifically authorized laboratories. ART outcome is favourable when only the man is infected, but seems to be less favourable when the woman is infected. Management of pregnancy planning should first propose to women infected by HIV, self inseminations when possible, and if needed, a quick ART treatment as some studies showed ovarian function alterations in HIV women. When the man is infected, IUI would be first proposed. Thousands of HIV positive male partners have used ART in Europe and no contamination has been reported so far. Approximately half of couples with one or both partners infected can hope to have a child through the ART process., (Copyright © 2011 Elsevier Masson SAS. All rights reserved.)

The French Biomedicine Agency was created in May 2005 by the August 2004 revision of the Bioethics Law. The Agency replaced the French Transplant Establishment, itself created by the first bioethics law in 1994. The Biomedicine Agency took over responsibility for organ, tissue and cell harvest and transplantation, but its remit now also covers medically assisted reproduction, antenatal diagnosis, human genetics, and embryo research, which it is required to "monitor, evaluate and control ". More generally, the Biomedicine Agency contributes to establishing regulations and to improving the quality and safety of healthcare practices and patient management. It is also responsible for promoting transparency in these fields, by preparing and distributing data on medically assisted reproduction and its results, and by keeping the public informed Finally, the Agency licenses and inspects healthcare professionals working in the fields of medically assisted reproduction, antenatal diagnosis and genetics. The Agency has bolstered its internal and external expertise in these new areas by calling on healthcare professionals and their scientific societies. It has thus created several task forces of healthcare professionals, who contribute their experience and their knowledge of day-to-day issues, with the aim of improving both regulations and practices. Finally, in order to constitute a solid framework for its development, the Agency has signed a performance contract with the ministry of health. This contract, covering the period 2007 to 2010, precisely defines the Agency's strategic objectives and actions, indicators for follow-up, and assessments of the means the Agency needs to carry out its missions. The Biomedicine Agency also actively seeks input from patients and user associations, especially with respect to the information it provides to the public.

Assisted reproductive technology (ART) for couples affected by HIV constitutes an important progress for public health. France has been the first country to offer this possibility on a national level, within the public health care system, with the best security and quality standards. This progress is, for one part, a consequence of the collaboration between community-based organizations representing HIV positive persons and their close relations, and pioneer medical teams in this field. This collaboration and this alliance have led to progressively convince the medical community and public health authorities concerned by the fight against aids of the usefulness of this care. Nevertheless, different obstacles have been encountered on the way between theory (decision of the Minister of Health, May 2001, allowing ART for couples affected by HIV), and practice. Medical teams often lack staff in sufficient number. Some doctors have, for reasons they qualify as ethical, refused to take HIV positive women into care. The opening of medical centers in areas where they are missing, particularly the French territories of America, remains a high priority. Last, the legal limits restricting access to ART in France deserve to be questioned. Community-based organizations and medical teams have been able to work as partners, sharing common goals of public health and quality of care. Nevertheless, among health institutions and national agencies in France, the consideration of the point of view of patients and their organizations is far from being a general rule, despite laws which clearly define patients' collective rights. We thank the Fédération française d'étude de la reproduction (FFER) and the journal Gynécologie Obstétrique & Fertilité for giving non-governmental organizations an opportunity to reaffirm our commitment to constructive common work.

Whilst maintaining the principle of a ban on embryo research, the bioethics law of August 6th 2004, updating the first bioethics laws passed in 1994, authorises French research teams to carry out studies and research on embryos or embryonic cells generated as part of an assisted reproduction programme, under special dispensation and for a maximum of five years from the date of publication of the decree of application of this text (Decree n(o) 2006-126, February 6th 2006, JO of 07/02/06). It also permits the importation and exportation of embryonic tissues and cells for such research and the storage of stem cells for scientific purposes. This highly supervised disposition is subject to control by the Biomedicine Agency, which is responsible for delivering and controlling authorisations for embryo research.

The search for improving the implantation rate of embryo transfer resulted in defining embryo quality standards, making it possible to select embryos with the best potential of implantation. A favorable uterine environment is the other primordial factor of successful embryo implantation. In addition to the endometrial thickness, which is a traditional criterion, many sonographic parameters likely to reflect the uterine receptivity state were studied. Lots of studies dealt with their predictive value and practical interest.

With the progress made in the treatments of assisted reproduction, implantation and pregnancy rates have increased. This evolution has led to increase the rates of multiple pregnancies in the general population. Considering maternal and fetal risks related to multiple pregnancies it was necessary to reduce their incidence. Several efforts have been tried, in particular the limitation of the number of embryos transferred to 2. This reduced the incidence of triplets but that of twin remained unchanged, which convinced the clinicians of the need to reduce further the number of embryo transfer. In Belgium a new policy of transfer was established by a law introduced since the 01/07/2003 aiming to reduce the costs related to the twin pregnancies and to increase the reimbursement of IVF treatments. We have studied the impact of this policy on the results at the clinic of Erasme. Two periods were compared : from 01/01/2001 to 30/06/2003 where the majority of the transfers was transfers of 2 embryos (56.8 %) and from 01/07/2003 to 31/12/2004 where the majority of the transfers was transfers of a single embryo (53.7 %) (p < 0.001). The rates of single embryo transfer were 12.5 % and 53.7 % respectively (p < 0.001). The rates of clinical pregnancies were 33.2 % and 27.3 % respectively (p < 0.001), on the other hand the percentage of twin pregnancies has strongly decreased from 29.9 % to 11.4 % (p < 0.001). The rate of frozen embryos has increased from 22 % policy seems to achieve its goals to the detriment of a reduction of the success rates. Nevertheless, the increase in the number of frozen embryos should allow, after thawing and transfer, to compensate at least partially this reduction of the pregnancy rate.

Objective: Comparative analysis of French results in Assisted Reproductive Techniques (ART) versus those from other European countries and the United States., Population and Methods: The study was achieved by using the officially available data. The analysis was faced with a lot of difficulties in relation with the various methods of collecting data in the different countries., Results: Nevertheless, it appears clearly that French results are among the lowest in Europe with a 22% rate for pregnancy per ovum pick-up with IVF and 23.4% with ICSI, when most of the other countries report rates that are close to or over 30%. Neither the patients' pick-up recruitment nor specific practices of ART can explain this difference that certainly comes from a deficient quality of the French IVF centres., Discussion and Conclusion: We think that four main end-points can explain this situation: the lack of financial support, the lack of human force, the lack of transparency and finally the opposition between clinician and biologist that has blocked the set-up of integrated ART centres, and probably a poor quality culture.

Selection is probably necessary for women undergoing ART (Assisted Reproductive Therapy), since cost of technique is very important. Furthermore, the right to try to achieve a pregnancy is a debatable issue, since the delivery rates are very low for ageing women. Success rates decrease strongly for women over 40, and women must be informed of it. Women 40 years or older are significantly less likely to achieve pregnancy with IUI as compared to women under age 35. The older women are also significantly less likely to achieve pregnancy with in vitro fertilization (IVF and IVF-ICSI). Costs per cycle were similar, however, for both groups. Moreover, older women utilizing assisted reproductive techniques are four to five times less likely to achieve normal delivery than the younger group, since pregnancy loss rate is greater. This poor prognosis for success in older women adds significantly to the mean cost per pregnancy as compared to younger women. Now, public institutions advocate and impose an age limit upon women who which to undergo ART. Ovulation induction should not be administrated for women over 45 years old (AFSSAPS, 2003). One should recommend not to propose to women over 42 years old and to men over 59 years old (Guidelines, 2004). Moreover, ART techniques cannot be reimbursed for women over 43 years old (CCAM, 2005).

The late 20th century trend to delay birth of the first child until the age at which female fecundity or reproductive capacity is lower has increased the incidence of age-related infertility. In the female, the number of oocytes decreases with age until the menopause. Oocyte quality also diminishes, due in part to increased aneuploidy. A significantly lower pregnancy rate per stimulation and delivery rate per retrieval is found in women aged 40 to 45 years when compared with women aged 25 to 39 years. However, acceptable pregnancy can be achieved in woman aged 40 to 43 years (4 to 8%). Furthermore, very few women aged over 40 ask for IVF procedure.