For the second time in its clinical trial, a Cleveland Clinic patient has given birth after receiving a transplanted uterus from a deceased donor. The first birth from this program was in June 2019.
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“This is one of very few live births from a deceased donor – every one of them is a landmark that confirms feasibility,” says transplant surgeon Andreas Tzakis, MD, who has spearheaded Cleveland Clinic’s efforts to develop and advance the procedure. “Until a few months ago, there was only one birth in North America. This birth is further proof of principle that deceased donor transplants can lead to joyous outcomes for our patients.”
A diagnosis of Mayer-Rokitansky-Küster-Hauser can be devastating for young women
In this case, the patient had Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome — a congenital abnormality in which Müllerian agenesis or hypoplasia leads to variable uterine development and partial absence of the vagina. Patients with MRKH are not usually diagnosed until mid to late puberty, and as they have functioning ovaries, tend to develop as expected until they reach an age by which menstruation is expected to begin. Incidence of MRKH is estimated at 1 in 4,500 women.
“It can be a devastating diagnosis,” says Stephanie Ricci, MD, an Ob/Gyn on the transplant team. “Often there is no external sign, so the news that they cannot carry a child comes as a great shock. I can’t tell you how much joy pregnancy and birth brings to these women.”
Patients who are selected for the clinical trial must first undergo in vitro fertilization (IVF) and cryopreservation of at least six embryos harvested by a team of IVF specialists. That is followed by a wait for a matching deceased donor (a woman of reproductive age who has previously given birth), the transplant surgery, immunosuppression and infection prophylaxis, embryo transfer, caesarean delivery and eventual hysterectomy to remove the graft after one or two pregnancies.
“At the time of transplant, this patient had significant clotting within the vascular outflow on the left side of her transplanted uterus,” Dr. Ricci notes. “Intraoperatively, the transplant team had to redivert the blood supply from the uterus – so the initial surgery was very long and complicated. The patient was put on anticoagulation postoperatively and remained on it throughout her pregnancy.”
“After uterus transplantation, we follow patients closely in the clinic — weekly at first, and then monthly. Patients generally begin to menstruate that first post-operative month, as was the case with this patient. With no sign of rejection after about six months, we begin preparations for embryo transfer,” Dr. Ricci explains.
Successful fertility treatment following transplant
“We retrieved 25 eggs from the patient prior to transplant. Of those, several were successfully fertilized and all but one developed normally to the blastocyst stage and were cryopreserved,” reports Elliott Richards, MD, Director of Reproductive Endocrinology and Infertility Research and co-investigator in Cleveland Clinic’s uterus transplant clinical trial.
Following transplant, in this case, “the patient’s menstrual cycle was evident within the first month, and her transplanted uterus responded beautifully to the hormones we prescribed to prepare the endometrial lining. Her embryo likewise looked to be of excellent quality. The process of embryo transfer was really no different than for any other IVF patient,” Dr. Richards continues.
“As in any embryo transfer, we first perform a ‘mock transfer’ to ensure that we can pass a tiny catheter through the cervix into the uterine cavity. Then the embryo is loaded onto an identical catheter and, under ultrasound guidance, the embryo is gently introduced into the upper portion of the uterine cavity. For this patient, we had easy visibility of the cervix and were able to transfer the embryo without difficulty. She then had a blood test 12 days later that confirmed pregnancy.”
In the available data on uterus transplants around the world, it’s pretty common for women to become pregnant very quickly, usually in one or two embryo transfers, according to Dr. Ricci. “These are generally young women in good health. In most cases, everything is functioning normally – they just didn’t have a uterus. In this patient, pregnancy was achieved after only one transfer.”
“In this case, the patient developed hypertension, which is a fairly common complication of pregnancy,” says Uma Perni, MD, a maternal-fetal medicine specialist who follows patients in the trial once pregnancy is achieved. “We delivered just prior to full term in order to avoid complications such as pre-eclampsia. The baby was quite healthy. He was taken to the NICU, and, after about one week, was discharged home without complications.”
Hysterectomy follows cesarean delivery
Once the baby was delivered, hysterectomy was performed.
“In our trial protocol, patients can opt to keep the uterus for a second pregnancy if they desire. In this case, the patient chose to have the uterus removed as she did not wish to remain on immunosuppression,” states Cristiano Quintini, MD, transplant surgeon and principal investigator on the trial.
Seeking to make uterus transplantation an option
“We want to establish uterus transplantation as a viable option for women with absolute uterine infertility. We accept that many women are happy with other solutions, such as adoption or surrogacy, but for some women these may not be an option for cultural or religious reasons. Other women may have a deep desire to experience pregnancy and childbirth for themselves. While still experimental, uterus transplantation programs like ours offer an opportunity to experience the responsibility and joy of carrying a baby. These births are all very special, joyous occasions for the family – and also for the entire transplant team,” says Dr. Tzakis.
“These two births were beautiful deliveries that have given us that much more energy and excitement to keep going,” Dr. Ricci concludes.