Uterus transplant now authorized in France

 

The National Safety Agency for Medicine and Health Products has just authorized a clinical trial for uterine transplant at the Limoges University Medical Center. The team working on this subject since 1999 has proposed a clinical trial protocol including eight women, which was approved by the Committee for Protecting People for the region.

Uterine transplants may benefit women suffering from a congenital absence of the organ (Rokitansky-Küster-Hauser Syndrome) which affects one woman out of 4500) or those having had a surgical ablation. To attain pregnancy, a uterine transplant must necessarily be preceded by In Vitro Fertilization with freezing of the embryos with the ovocytes of the woman grafted or with those from a donor. For the moment, the National Health and Safety Agency wishes to limit the trial to women who have not yet had children.

« At the earliest, the first graft will be performed by the end of 2016, with the unknown input of when a compatible graft can actually be found. Then, we must wait one year for the graft to be stable, before starting a pregnancy using in vitro fertilization. Therefore, the first birth won’t be before the end of 2018” explains Tristan Gauthier, obstetrical gynecologist at the Limoges university hospital and principal investigator for the trial.

The graft of a uterus is different from all other grafts. “Although not a vital organ, it is the one by which life is given”, recalled the authors of a report published by the Medical Academy in June 2015. In the report, they insisted on the “complexity of the surgical act, the dilemma of choosing between a donor in a state of cerebral death or deceased, and a living donor and the specifications of the recipient. They continued by describing the immunosuppressive therapy before and during pregnancy, the complications more or less severe which could occur during pregnancy and the necessity for specifically attentive surveillance. They questioned the future of the child, in the medium and long-term, his psychomotor development, and that of his immune system and went through the numerous and delicate ethical questions which uterine transplantation presents, the risks for the recipient, the physiological and psychological outcome of the child, and finally the question of the choice between uterine transplant and surrogate motherhood, and the potential drifts.

As for the choice of procuring uteri from donors in a state of cerebral death, « it is the result of an ethical approach, to avoid invasive surgery on healthy patients to procure a non-vital organ for recipients.” But the doctors also hope thatby giving preference to deceased donors, they will be able to use younger uteri, and consequently more effective than those of living donors, who are generally women who do not wish to have children anymore”, underlined Dr. Piver. Other sources of donor might be possible, as Foch hospital mentioned for transsexual women who have become men.

A uterine graft performed in Sweden in October 2014, allowed the world’s first birth of a child from uterine transplant. The team had tempted 9 transplants performed in the context of a project initially refused by the Swedish Ethical Committee. Among the 9 women, 8 had the MKRH syndrome and the ninth had cervical cancer which led to the removal of the uterus. Most of the grafts were performed with uteri taken from living mothers for their own daughters. Out of the nine grafts, two failed (infections, thrombosis), four have not yet given rise to pregnancy. But three were successful. “Three births out of nine trials is almost as good as medically assisted reproduction techniques”, thus analyzed Dr Tristan Gauthier.

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