Researchers have been given the green light for first clinical trial of uterus transplantation in the US.
The new trial, which will be led by Dr. Andreas Tzakis of the Transplantation Center at Cleveland, will involve performing uterus transplants on 10 women with uterine factor infertility (UFI).
The announcement comes just weeks after Medical News Today reported that a team of researchers has been given the go-ahead for a similar clinical trial in the UK.
In UFI, a woman has abnormalities of the uterus that prevent her from becoming pregnant. This can include being born without a uterus, uterine fibroids - noncancerous growths within the uterus - or abnormalities as a result of infection or surgery.
There are limited treatment options for women with UFI. "Although adoption and surrogacy provide opportunities for parenthood, both pose logistical challenges and may not be acceptable due to personal, cultural or legal reasons," notes Dr. Tommaso Falcone, of the Obstetrics and Gynecology Department at Cleveland.
But in September 2014 came hope for a new treatment for UFI, after a woman in Sweden who was born without a uterus became the first to give birth to a healthy baby after undergoing a uterus transplant.
This success story has spurred the procedure to be trialed elsewhere, in the hope it can give women with UFI the chance to carry their own babies.
"The exciting work from the investigators in Sweden demonstrated that uterine transplantation can result in the successful delivery of healthy infants," says Dr. Tzakis.
How will the new trial be conducted?
Last month, researchers at Cleveland began screening women aged 21-39 with UFI to take part in the trial, after it received approval from the hospital's Institutional Review Board.
Each potential candidate must undergo a series of rigorous medical and psychological evaluations, and once a woman is approved for the trial, a strict procedure will follow.
- Infertility is defined as the inability to get pregnant after 1 year of unprotected sex
- Around 12% of women in the US aged 15-44 have difficulty getting pregnant or sustaining a pregnancy
- The likelihood of fertility problems increases with age; around a third of couples in which the woman is older than 35 years have fertility problems.
First, a patient's ovaries will be stimulated to produce multiple eggs, which will then be retrieved, fertilized with sperm in a lab and frozen.
Next comes the search for a donor, which will be conducted by Lifebanc - an organ procurement organization. Once a donor is found and the consent procedure is completed, the uterus transplant can go ahead.
The donor uterus will take an average of 6-8 hours to transplant into the recipient's pelvis, and it will take around 12 months for the uterus to fully heal.
After the transplanted uterus has healed, the frozen embryos will be thawed and implanted into the uterus one by one until the patient becomes pregnant.
The patient will need to take medication to prevent the donated uterus from being rejected throughout the pregnancy, and she will receive monthly cervical biopsies to monitor rejection and receive regular monitoring by a high-risk obstetrics team.
The patient will give birth via a cesarean section. After having one or two children, the patient will have the uterus removed. "Unlike any other transplants, they are 'ephemeral,'" notes Dr. Tzakis. "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."
After the uterus has been removed, anti-rejection medication will be ceased in order to prevent long-term exposure to the drugs.
Commenting on becoming the first team in the US to trial such a procedure, Dr. Falcone says:
"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."
Last month, MNT reported on a study detailing a new DNA test that researchers say could boost in vitro fertilization (IVF) success rates to as much as 80%.