Baylor researchers to begin clinical trial to test womb transplants

By Al Saint Jacques, MDLinx
Published January 30, 2016

Key Takeaways

A clinical trial is among the first being performed to assess the use of womb transplants in women with absolute uterine factor infertility, meaning their uterus is nonfunctioning or nonexistent. The objective is to give women a chance to become pregnant and carry a child full term, according to information provided by Baylor University Medical Center in Dallas, TX.

"We strongly believe in this clinical trial and its potential to change lives," explained Goran Klintmalm, MD, PhD, FACS, chief and chairman of Baylor Annette C. and Harold C. Simmons Transplant Institute at Baylor University Medical Center.

The upcoming trial is scheduled to involve 10 women, and researchers anticipate that the first baby to be carried by a transplanted womb in the United States could be born in 2017. The complex process involves a multi-disciplinary collaboration at Baylor University Medical Center among obstetrician-gynecologists (ob-gyns), fertility specialists, as well as the transplant team.

"The entire process of transplantation, fertilization, prenatal care and delivery—they're all connected as part of this study, and they'll all take place at Baylor University Medical Center at Dallas," noted Giuliano Testa, MD, principal investigator and surgical chief of abdominal transplantation at Baylor University Medical Center. "All of these components are integrated with one goal in mind: helping women who've been previously unable to have a baby."

In the Baylor trial, investigators will include women between 20 and 35 years old with absolute uterine factor infertility, intact ovaries, and the desire to carry a baby to term, among other criteria. Living donors should be between 40 and 65 years old and have previously carried at least one baby to term, among other criteria (menopause is not required). Baylor University Medical Center's first womb transplant surgery is expected to be done in 2016 with the final patient pool of recipients totaling 10 women.

Before the surgery, each participant will undergo in-vitro fertilization (IVF), which is possible because qualified patients must have healthy and otherwise normal functioning ovaries. After surgery, study subjects will be monitored and may be eligible for an embryo produced from the earlier IVF procedures to be transferred as early as a year following the womb transplant. If implantation is successful and the recipient becomes pregnant, she will be routinely monitored until her baby is delivered by cesarean section.

While the transplant procedure could offer a new option for many infertile women who want to carry their own baby, the researchers stress that it's not designed as a permanent organ donation. Because carrying foreign body tissue can increase infection risk and requires taking regular anti-rejection medication, the researchers explained that women in this study will undergo a hysterectomy after one or two successful pregnancies. For this reason, the women who want a second pregnancy will have shorter windows of time between births.

"Because this surgery is not a lifesaving transplant like a liver or kidney, there's no need for the patients to take the anti-rejection medications once they've achieved their goal, which is to have a baby," Dr. Testa said, adding that if there is no pregnancy, the women will still need to have a hysterectomy.

Previously, a trial in Sweden for women with absolute uterine factor infertility resulted in seven successful womb transplants and five live births. In 2014, a 36-year-old Swedish participant in that trial became the first woman in the world to give birth to a baby via a donated uterus. The Swedish study took place after more than a decade of lab research that showed promising results for this procedure.

Dr. Testa and his team will apply the insights of those outcomes to this study, with special input from the researchers involved in the initial effort at Sahlgrenska University Hospital in Gothenburg, Sweden.

"They were the pioneers for this," said Dr. Testa. "The Swedish researchers have paved the way to make this possible, and we're going to build on that."

Of the 62 million women in the U.S. who are of reproductive age, approximately 15.4% of them may have absolute uterine factor infertility, meaning that expansion of this study could benefit thousands of women who hope to carry their own biological children. If 2017 brings babies successfully born from transplanted wombs, those new options for women hoping to bear children may come by the end of the decade, or sooner.

"If we're as successful as we believe we'll be in helping women have full-term healthy pregnancies with the transplantations, then we will open this option to every woman who is willing to undergo a transplant to have a child," Dr. Testa said.

To learn more about this study, including eligibility requirements, call 1-800-4BAYLOR.

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