A near miracle occurred at Penn Medicine’s Hospital of the University of Pennsylvania as Benjamin Thomas Gobrecht’s birth defined “expectation and imagination” as his mother, born without a uterus, received an organ as part of an organ transplant clinical trial a year earlier. Baby Benjamin is the first baby born as part of Penn Medicine’s “Uterus Transplantation for Uterine Factor Infertility” (UNTIL) trial, which commenced in 2017. Benjamin is only the second baby born following the transplantation of a uterus from a deceased donor. The study’s principal investigator is Kathleen E. O’Neill.

UNTIL Trial

Penn Medicine, under the UNTIL trial, A novel and innovative uterine transplantation clinical trial allowed a woman, Jennifer Gobrecht, born without a uterus, and her husband Drew, to welcome their baby boy in November 2019. A first of its kind clinical trial in the Northeastern United States, the trial commenced in 2017 as a joint effort between the Penn Transplant Institute and the Department of Obstetrics and Gynecology.

The study has successfully achieved a live birth after uterus transplantation from deceased donors. The investigators, according to the study protocol, planned to study five women who would ultimately undergo embryo transfer, pregnancy, delivery, and then transplant removal.

The Penn UNTIL trial is divided into two distinct phases. In phase I, study subjects are screened, enrolled, evaluated, generate embryos, and ultimately undergo uterine transplantation. This phase of the trial is a feasibility study whose primary outcome is a successful transplant of a uterus from a deceased donor into a living recipient. In Phase II, women with successful deceased donor uterine transplants will have embryos implanted to ultimately attain the objective of live birth. This trial promises to expand the benefits of transplantation to a novel group of individuals who have a devastating diagnosis.

This trial is excepting women in need of a transplant, and also women who are interested in being a live donor.

The Key Trial Milestone

The birth of baby Benjamin was a significant milestone for this clinical trial—representing only the second child in America to be born following transplantation of a uterus from a deceased donor.

The Condition

Gobrecht was born with a congenital condition called Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome, which means she has functional ovaries but does not have a fully formed uterus. MRKH affects approximately 1 out of every 4,500 females and makes it impossible for women to get pregnant or carry a child. It’s one example of uterine factor infertility (UFI), which is a previously irreversible form of female infertility that affects as many as five percent of reproductive-aged women worldwide. A person with UFI cannot carry a pregnancy because she was either born without a uterus, has had the organ surgically removed, or has a uterus that does not function properly.

What is Uterus Transplantation?

A promising potential treatment for women with Uterine Factor Infertility (UFI) which represents a previously irreversible form of female infertility that affects hundreds of thousands of reproductive-age women in the United States, reports Penn Medicine. Until now, a woman with UFI could not carry a pregnancy. UFI could represent a scenario where a uterus is removed, or the uterus doesn’t function, and the uterus transplant offers the chance to carry and deliver a child.

UNTIL Trial Difference

There have been successful transplantations involving living donors, and in fact, Penn Medicine reports that about 70 uterus transplants have occurred globally. However, Penn Medicine’s trial is one of a few such studies to investigate the transplantation process from both living and deceased donors. This represents an approach that offers the potential to greatly expand the pool of organs available for donation and supports the ability of investigators to directly compare outcomes from the different types of donors.

UNTIL is the only such trial actively enrolling patients in the United States.

Lead Research/Investigator

Kathleen E. O’Neill, MD, MTR

Paige Orrett, MD, PhD

Call to Action: Interested in learning more about this study? Read the source Penn Medicine publication as well as register for TrialSite News Daily Digest for daily updates as they are live. The study’s principal investigator can be contacted here.

Source: Penn Today

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