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.

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.

The Doctors Leading the Uterus Transplant Team at the Cleveland Clinic

from left: Andreas G. Tzakis, Uma Perni, Rebecca Flyckt and Tommaso Falcone

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."

Image of Uterus and Ovaries 

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. 

THE DONOR: Surgeons remove the uterus, cervix and part of the vagina from an organ donor who has recently died, along with the small uterine vessels that carry blood to the organ. The uterus can survive outside the body for at least six to eight hours if kept cold.

THE RECIPIENT: The donor's uterus is connected to the recipient's vagina and the uterine vessels are redirected to large blood vessels running outside the pelvis. The recipient's ovaries are left in place, and if she has any remnant fallopian tubes, they are not connected to the transplant. The recipient will wait a year to heal before having in vitro fertilization.

Once a Patient is Approved for the Study, she Follows a 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.

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.

First Married Man to Have a Baby (Transgender Female to Male)

After last week's announcement that the Cleveland Clinic is performing uterus transplant surgery on women who were born without a womb or whose uterus is diseased or malfunctioning, many began to wonder whether this medical advancement could be replicated in men.  The simple answer is yes. Theoretically, men could receive a uterus, carry a baby to term, and give birth. But what really blew our minds is that the day of male pregnancy is closer than you'd think. "My guess is five, 10 years away, maybe sooner," says Dr. Karine Chung, director of the fertility preservation program at the University of Southern California's Keck School of Medicine.  "Today, medical advances let transgender women adjust their biochemistry to suppress male and introduce female hormones, have breasts that can lactate, and obtain surgically constructed vaginas that include a "neoclitoris," which allows sensation."

Until now, however, a place to carry the fetus — a womb of its own — was a major missing link. Uterus transplants could conceivably surmount that hurdle. "I'd bet just about every transgender person who is female will want to do it, if it were covered by insurance," says Dr. Christine McGinn, a New Hope, Pa., plastic surgeon who performs transgender surgeries on men and women and is a consultant to the new movie The Danish Girl, about one of the first recipients of sex reassignment surgery. McGinn, a transgender woman and mother of twins, says the "human drive to be a mother for a woman is a very serious thing. Transgender women are no different." Uterus transplants are still in the research stage for women suffering from uterine factor infertility (UFI). A Swedish team already has successfully transplanted uteri harvested from live donors and achieved five pregnancies and four live births. In the coming months, the Cleveland Clinic team plans to transplant uteri from deceased donors into UFI female patients. Transplant surgery is difficult and dangerous, requiring patients to take antirejection drugs throughout their pregnancies, putting them at risk for infection. But for many women — and presumably for many transitioning women — the risk is worth the reward. However, biological women have a leg up on biological males when it comes to accepting and nurturing a transplanted uterus. Women already have: vasculature needed to feed the uterus with blood, pelvic ligaments designed to support a uterus, a vagina and cervix, and natural hormones that prepare the uterus for implantation and support the pregnancy. Men have none of those support systems — naturally — but none are impossible to create. "Male and female anatomy is not that different," says Chung. "Probably at some point, somebody will figure out how to make that work." In fact, medical techniques already exist to overcome many obstacles to male pregnancy. Hormone therapy can shut off testosterone and introduce progesterone and estrogen needed to prepare the uterus for pregnancy.