Uterine Transplant for Women With Absolute Uterine Factor Infertility (AUFI)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-65
SponsorJohn Goss
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women of childbearing age (20-40 years old) who are biologically female (XX karyotype).
Subjects will not have active human 142 papillomavirus (HPV) or active cervical dysplasia present.
Subjects will have negative testing for Gonorrhea Chlamydia and Syphilis and will not have any active bacterial vaginosis or candida infection. (Subjects with previously treated STDs will be included if the infection is no longer present and has no impact. If a subject develops an STD/infection pre-operatively, she will be treated and monitored for a period of 3 months until she is no longer affected. She will then become eligible for transplant. If a subject develops an STD/infection after transplant/during pregnancy she will be treated appropriately. Prior to the embryo transfer the patient will be tested and treated if necessary. Any patient with an active STD/infection will be ineligible for any elective procedure until she is tested and treated appropriately.)
Subjects who are HSV-2 negative or who have a history of HSV-2 with no current symptoms. Subjects may require preventative maintenance per study doctor discretion.
Disqualifiers
Subject with Diabetes Mellitus Type I and II by medical history or elevated hemoglobin A1c blood test.
Subject has known hypersensitivity to Tacrolimus, Thymoglobulin or Everolimus.
Subject with a diagnosis of hypertension, or any other significant medical condition that makes this procedure unsafe or is a contraindication to surgery or anesthesia.
Subject who has a history of solid organ or bone marrow transplant, per investigator's discretion.
Trial design
Design model
Single group
Treatments tested in this trial
Uterine Transplant
Other interventionTransplant of a uterus from a live or deceased donor.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Uterine TransplantExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants that have successful procurement of a viable uterus for transplant.
A viable uterus is a uterine allograft that is fully procured and is suitable for transplantation into the recipient. This is measured at the time of procurement by visible inspection to ensure the vascular structures (uterine artery and vein) are not injured and the vaginal cuff is intact.
Time frame
Day of organ procurement immediately post-operative2
Number of participants that have a score of II or less on the Clavian-Dindo Scale.
Each patient will be reviewed and any complications scored using the Clavian Dindo Scale.
Time frame
30 days post-operative3
Successful transplantation of a human uterus with achievement of menstrual cycles
As determined by 1. Achievement of menstrual cycles at 3 months post-operative, and 2. Graft viability measured by assessing blood flow via ultrasound and using cervical biopsies to look for ischemia or allograft rejection.
Time frame
3 months post-operative4
Successful establishment of a pregnancy via in vitro fertilization
Visibility of a gestational sac on US at 6 weeks
Time frame
6 weeks post IVFSponsors and contacts
Click on the lead sponsor to view all of their trials.
John Goss
Lead sponsor
Baylor College of Medicine
Sponsor institution
Source ClinicalTrials.gov