A large team of Cleveland Clinic surgeons performed the nation’s first uterus transplant on Feb. 24, 2016. The nine-hour surgery was the first in a research study — groundbreaking for the United States — that will eventually allow 10 women with uterine factor infertility (UFI) to receive uterus transplants.

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Pregnancy is not an option for women with UFI. They cannot carry a pregnancy because they were born without a uterus, have lost their uterus, or have a uterus that no longer functions.

“Although there appears to be potential for treating UFI with uterine transplantation, it is still considered highly experimental,” says Tommaso Falcone, MD, Ob/Gyn & Women’s Health Institute Chair. “Cleveland Clinic has a history of innovation in transplant and reproductive surgery and will explore the feasibility of this approach for women in the United States.”

A ray of hope

The exact incidence of UFI is unknown, but experts estimate that it affects thousands of women of childbearing age worldwide. Some have congenital UFI, meaning that the uterus is absent at birth (as in Mayer-Rokitansky and other syndromes). Others acquire UFI after hysterectomy or because of damage from a serious pelvic infection, or abdominal or pelvic surgery.

Uterus transplant offers them a ray of hope. “Women who are coping with UFI have few existing options,” explains Dr. Falcone. “Although adoption and surrogacy provide opportunities for parenthood, both pose logistical challenges and may not be acceptable due to personal, cultural or legal reasons.”

Although arranging for a gestational carrier (surrogacy) is an option in the United States, it can become legally complicated. In other countries, surrogacy is often highly restricted or banned outright.

Research in Sweden pays off

The first two international attempts at uterus transplant were unsuccessful. Organ rejection during pregnancy was a major factor. After years of pioneering research and human trials (in which Cleveland Clinic took part) a Swedish team was able to manage the mild organ rejection that can occur.

That University of Gothenberg team achieved its first birth in September 2014. To date, the Swedish group has performed nine uterus transplants, achieving five pregnancies and four live births.

“The exciting work from the investigators in Sweden demonstrated that uterine transplantation can result in the successful delivery of healthy infants,” says Cleveland Clinic lead investigator Andreas Tzakis, MD.

Study uses team approach

Cleveland Clinic recognizes that care from a team of experts in different disciplines produces the best possible outcomes for the patient. Close coordination among the reproductive and transplant surgeons, infertility and IVF specialist Rebecca Flyckt, MD, and high-risk obstetrician Uma Perni, MD, will be crucial to the procedure’s success.

“Study participants will also benefit from the full support of a team of Cleveland Clinic doctors, psychologists, social workers, patient advocates and bioethicists,” notes Dr. Flyckt.

Adds Dr. Falcone: “We are proud to have received approval to move forward with this novel study. It is a product of many years of research, the expertise of our medical teams and the support of our organization.”

Uterus transplant: A multi-step process

With the green light from its Institutional Review Board, Cleveland Clinic began screening 21-to-39-year-old women with UFI for transplant in September. Each candidate faces extensive rounds of medical and psychological evaluations by experts from different disciplines and must be unanimously approved by the team.

Once a patient is approved for the study, she follows this complex, intricate protocol:

Her ovaries are stimulated to produce multiple eggs, starting the in vitro fertilization (IVF) process.

Her eggs are retrieved, fertilized with sperm in a laboratory, and frozen.

Lifebanc, an organ procurement agency, begins the search for a donor.

The donor’s next-of-kin signs an informed consent for uterus donation.

The donor uterus is transplanted within six to eight hours into the patient’s pelvis.

Over 12 months, the transplanted uterus fully heals.

One year after transplant, the frozen embryos are then thawed and implanted, one at a time, into the patient until she becomes pregnant.

During her pregnancy, she takes anti-rejection drugs.

She is monitored by a high-risk obstetrics team throughout pregnancy and delivery.

She has a monthly cervical biopsy to check for organ rejection.

The baby is delivered by cesarean section.

After one to two babies, she has a hysterectomy to remove the transplanted uterus.

Her anti-rejection drugs are stopped after hysterectomy to reduce long-term exposure to transplant medications.

A temporary measure

It is critical that the risks for uterus transplant, which is not lifesaving, are no greater than the risks for other transplants. Like transplants of the face and extremities, uterus transplant is considered life-enhancing rather than lifesaving, says Dr. Tzakis.

Yet uterus transplants remain unique. “Unlike any other transplants, they are ‘ephemeral,’” he says. “They are not intended to last for the duration of the recipient’s life, but will be maintained for only as long as is necessary to produce one or two children.”

For women with UFI, this temporary measure offers the possibility of lasting change as they experience pregnancy for the very first time.