Cleveland Clinic obstetricians and transplant surgeons have carefully followed clinical trials of uterine transplantation conducted in Sweden. Over a six-month period, the Swedish team performed transplants in nine women using uteri from related and unrelated living donors. One year later, they implanted cryopreserved embryos in all but two patients, who had rejected the uteri.  Three patients achieved viable pregnancy.

Then in September, one of the women gave birth to a healthy baby boy by caesarian section. It was a satisfying culmination of 10 years of dedicated research.

“I remember that at a meeting eight or nine years ago most people were skeptical that uterine transplant was feasible,” remembers Tommaso Falcone, MD, Chair of the Ob/Gyn & Women’s Health Institute at Cleveland Clinic. “But this is an important development that will give women with congenital or surgical absence of the uterus an opportunity to give birth. The future is definitely exciting,” he says.

Dr. Falcone and his colleagues have applied to the Cleveland Clinic institutional review board (IRB) to begin a uterine transplantation program. Because transplantation of this organ is a distinct departure from transplantation of conventional organs, approval may hinge on educating IRB members about the advantages, while being realistic about the known and unknown risks at this point in time.

Sometimes the only option

Infertility is a major issue for thousands of women across the world. For those with uterine factor infertility caused by congenital absence or removal of the uterus, traditional assisted-reproduction technologies may not be feasible. Although adoption and surrogacy provide opportunities for parenthood, both options pose logistical challenges and may not be acceptable due to personal, cultural or legal reasons.

“Surrogacy, the major approach in this country, is not routine because it is fraught with legal problems,” says Dr. Falcone. “Additionally, surrogacy is banned or highly restricted in Europe and Canada, and is unquestionably banned in Muslim countries. Therefore, uterine transplantation is the only hope for some women with no uterus.”

Important clinical and ethical considerations

Behind the successful birth of a child following uterine transplant is a series of medical and ethical challenges never before faced in organ transplantation.

“The unique aspects of uterine transplantation will need ongoing multidisciplinary analysis of the lead clinical and ethical issues for the donor, recipient, offspring, and other key stakeholders involved in this innovative family-building procedure,” said Dr. Falcone and his colleague, Ruth Farrell, MD, in an editorial published online in The Lancet  Oct. 8, 2014.

Risks to both donor and recipient

In their editorial, Drs. Falcone and Ferrell delineate the many challenges involved in the transplant procedure, as well as those encountered during and after pregnancy.

For donors, the challenges include:

• Risks of using oral contraceptives to optimize uterine vasculature in postmenopausal uterine donors
• Ethical considerations of removing a functioning uterus from a live donor
• Risks associated with the prolonged operative and anesthesia times required for organ removal.

Cleveland Clinic plans to address these issues initially by using cadaver donors, with the uterus harvested at the same time as other organs. However, they are also requesting permission to accept live donors at a later date.  Cleveland Clinic transplant surgeons are studying new techniques to simplify uterine removal.

For recipients, the unresolved issues include:

• The potential for infection and thrombosis in the transplanted uterus
• Potential development of pre-eclampsia, preterm contractions and acute rejection of the uterus
• Risks associated with preterm delivery
• Risks associated with eventual removal of the transplanted organ

Until more is known, Cleveland Clinic plans to use the same candidate-selection criteria used in Sweden.

Financial considerations

Who will pay for uterine transplantation is an overriding question. Unlike the liver or heart, the uterus is not a vital organ. In this respect, uterine transplantation is similar to hand, leg and face transplants, which are life-enhancing, but not life-prolonging. Therefore, neither the donor nor the recipient is likely to be covered by insurance.

Uterine transplantation is also unique in that it is intended to be temporary. Because its benefit ceases after childbearing is complete, the organ will be removed or allowed to be rejected after one or two children are born. This eliminates the need for lifelong immunosuppression and its associated medical problems, but entails another surgery and hospitalization.

With three surgeries involved, uterine transplantation will certainly be beyond the financial reach of the average woman.

The good news is that once these hurdles are overcome, uterine transplantation can help many women bear their own children.