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Baylor University Medical Center to offer uterus transplants in clinical trial

They say motherhood is a gift. It’s that surreal and unforgettable moment of holding your newborn in your arms for the first time, gazing into a tiny face you feel like you’ve known your whole life. But for some, life throws a curve ball, extinguishing high hopes of motherhood for many women diagnosed with infertility.

Baylor Scott & White Health aims to reignite hope for millions of women worldwide who are thought to be infertile because of the absence of a uterus caused by a birth defect or prior medical treatments. A new clinical trial is being conducted at Baylor University Medical Center at Dallas to give these women a chance to become pregnant and carry a child.

The clinical trial will implant wombs in ten women with absolute uterine factor infertility (AUI), meaning they have a nonfunctioning uterus — or lack of one entirely. The complex process involves collaboration between ob-gyns, fertility specialists, maternal/fetal medicine specialists, as well as the transplant team with the Baylor Annette C. and Harold C. Simmons Transplant Institute at Baylor University Medical Center at Dallas.

Ten women will receive a donated uterus, and after a year of monitoring, their own fertilized embryos will be implanted with the hope of a healthy pregnancy and a live birth.

Baylor University Medical Center researchers are among the first in the U.S. to explore uterus transplantation as a new infertility treatment option. The team of researchers anticipates that the first baby carried by a transplanted womb in the U.S. could be born in 2017. Transplanted wombs can come from both living and deceased donors of all adult ages, even post-menopausal women.

What is unique to this study is that researchers at Baylor University Medical Center plan to include both types of donors.

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

How do womb transplants work?

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“Explore."

PHASE 1: In-Vitro
Prior to the surgery, the transplant recipient will undergo in-vitro fertilization (IVF). IVF uses reproductive technology to retrieve eggs from the ovaries and fertilize them with sperm from the subject’s male partner in a lab. The embryos are then preserved.

PHASE 2: Transplantation
During the transplantation process, the donor’s womb is removed and implanted into the recipient.

PHASE 3: Recovery
As with any transplant surgery, the recipients will need to take special medication following the procedure to ensure the donated organs are not rejected by their bodies. Previous research has shown that anti-rejection drugs are safe to take during pregnancy, and thousands of women with donor kidneys or livers, who must continue taking anti-rejection drugs while pregnant, have given birth to healthy babies.

PHASE 4: Embryo Transfer
After surgery, the women will be monitored and may be eligible for an embryo produced from the earlier IVF procedures to be transferred around 12 months following the womb transplant.

PHASE 5: Pregnancy
If implantation is successful and the recipients become pregnant, they will be routinely monitored with the goal of their babies arriving by cesarean section around eight months into the pregnancy. After a successful live birth, the recipient may have the option to keep the uterus for a second pregnancy. The physicians will consider the course of the first pregnancy and together with the mother, determine when and how to move forward safely towards a second pregnancy.

“All of these components are integrated with one goal in mind: helping women who’ve been previously unable to have a baby.”

While the transplant procedure could offer a new option for many infertile women who want to carry their own baby, researchers stress that it’s not designed as a permanent organ donation. Because carrying foreign body tissue can increase infection risk and requires lifelong anti-rejection medication, women in this study will undergo a hysterectomy after one or two successful pregnancies.

“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,” said 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.”

Success in Sweden: Paving the road for uterine transplants

A similar trial in Sweden has 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.

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

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Potential to impact thousands

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 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 uterine transplants, this study and eligibility requirements, call 1-800-4BAYLOR or send us an email.

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Megan McCook
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Baylor University Medical Center to offer uterus transplants in clinical trial