Uterine Transplant for Women With Absolute Uterine Factor Infertility (AUFI)

Infertility of Uterine Origin Clinical Trial

Official title: Uterine Transplantation and Pregnancy Induction in Women Affected by Absolute Uterine Factor Infertility

Status Recruiting

Clinical Trial Summary

Absolute Uterine Factor Infertility (AUFI) is due to congenital or surgical absence of a uterus or the presence of a nonfunctional uterus. Until 2014, the only option for women affected by Absolute Uterine Factor Infertility (AUFI) was adoption or surrogate motherhood. Uterine transplant is a new form of transplant to treat AUFI. The technique of uterus transplant was developed in Sweden with the transplantation of the uterus from a living donor to a woman affected by AUFI. Approximately 80 uterine transplantations have been performed, more than 50 of which have occurred within the past 3 years. To date, 34 children have been born from mothers who have received a living donor uterine transplant.

This is a prospective study to treat Absolute Uterine Factor Infertility (AUFI) through uterine transplantation utilizing a uterus from a living or deceased donor resulting in live birth. A total of 10 biologically female (XX Karyotype) subjects will receive a uterine transplant.

Clinical Trial Description

BACKGROUND: The feasibility of uterine transplant has been studied for more than a decade. The clinical concept and the technical aspects were first tested and proven in non-primates and then in primate experiments. In 2013, the first human trial started at the University of Gothenburg in Sweden. In 2014, the first live birth from a woman who had received a uterine transplant was announced (1). This first live birth was then followed by additional births. Uterine transplant may provide an additional option for women with Absolute Uterine Factor Infertility (AUFI).

STUDY DESIGN: This trial will be conducted at Texas Children's Hospital - Pavilion for Women. Texas Children's Hospital was established in 1954. Today it has one of the nation's top pediatric transplant programs. The transplant center has performed more than 2000 solid organ transplants including liver, kidney, heart and lung transplants. This is a non-randomized, interventional study with the goal of achieving pregnancy and live birth of a child following uterine transplantation using either a live or deceased uterus donor. The investigators plan to perform 10 uterine transplants in this study.

The evaluation for receiving a uterine transplant will include consults with specialists and a variety of procedures. The consultations, tests and procedures will evaluate if the recipient is physically, emotionally, and mentally prepared to participate. After the evaluations are complete, the principal investigator and coordinator will present the findings to the rest of the uterine team. The team will decide if the subject is a candidate for moving forward to the IVF part of the screening process. After successful completion of egg retrieval and fertilization, the embryos will be banked. Only those study subjects that have four or more high quality embryos will be the criteria to be listed as uterine transplant recipients. Preimplantation Genetic Testing for Aneuploidy will be done. Once the subject has undergone uterine transplantation, she will be monitored for infection, rejection and other complications.

Once it has been determined that the study subject is ready for the embryo transfer, the subject will undergo a process to prepare the uterus to receive the embryo (embryo transfer). The endometrium will be stimulated to grow with estrogen until a desired thickness of the lining has been obtained. A second hormone, progesterone, will be given by injection daily until the endometrial lining is receptive to transfer of the embryo. On the day of the transfer, the embryo will be thawed and then transferred into the uterus by means of a sterile catheter system under ultrasound guidance to determine the proper placement of the embryo into the uterus. The study subject will be awake during this process. Twelve days later, blood tests will be performed to detect the pregnancy hormone, HCG. The levels of the pregnancy hormone and the estrogen and progesterone levels will be closely monitored. At eight weeks gestation, the study subject will undergo an ultrasound evaluation to see if there is viable pregnancy. The study subject will then be closely monitored by the fertility specialist until about 11 weeks, and then by a Maternal-Fetal Medicine (MFM) specialist.

All deliveries will be performed via cesarean section. Following delivery, the subject will have the opportunity to discuss with the transplant and Ob/Gyn team the possibility of a second pregnancy or explant of the uterus. If a second pregnancy is anticipated the subject must be deemed medically stable to undergo the embryo transfer and a second-high risk pregnancy. The subject and team will determine the timeline for a second pregnancy if the subject so chooses. If the subject chooses to undergo a second pregnancy, she will be followed by a Maternal Fetal Medicine specialist and delivery via repeat cesarean delivery. After delivery of the first pregnancy, a decision about a second pregnancy or an explant will not be made until at least 60 days post-delivery to allow time to evaluate the health of the newborn as well as the candidacy of the subject for a possible second pregnancy (if desired). In the case of a second pregnancy, the plan will be to perform a hysterectomy of the uterine allograft at the time of cesarean delivery of the second child.

The transplanted uterus will be from either living or deceased donors. TXTC wants to be certain that the living donor's decision to donate is made freely, and with all of the information needed to consider donation. For that reason, TXTC has an agreement with the Living Bank that will serve as an independent third party advocating for the rights and needs of the donor through the evaluation and donation process. UNOS is the only source for deceased donor organs. Locally, TXTC works with the Lifegift OPO to procure organs for transplant. ;

Related Conditions & MeSH terms

• Infertility
• Infertility of Uterine Origin
• Mayer Rokitansky Kuster Hauser Syndrome

• NCT number: NCT05263076
• Study type: Interventional
• Source: Baylor College of Medicine
• Contact: Transplant Services Coordinator
• Phone: 832-822-1551
• Email: uterustransplant@texaschildrens.org
• Status: Recruiting
• Phase: N/A
• Start date: June 3, 2022
• Completion date: December 2030