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This research study will use uterus transplantation to treat uterine factor infertility, also known as the inability to bear children due to not having a uterus. The purpose of this study is to enable women seeking genetically-related children and the childbearing experience to experience pregnancy and birth a child. In this study, living donors will undergo surgery to give the donor's uterus to another woman. The woman who receives the transplant will take immunosuppression to keep the uterus and herself healthy. Because taking immunosuppressive medicine has side effects, uterus transplantation is intended to be temporary, lasting about 5 years.
The goals of the study are successful pregnancy and the birth of one, and possibly two, healthy babies per transplant patient. The uterus is to be removed and immunosuppression stopped following the birth of a child. Offspring are delivered by Caesarian section, at which time the transplant may also be removed.
Transplant candidates must have fertilized, frozen (cryopreserved) embryos at a Johns Hopkins facility before undergoing transplantation. Transplant candidates will be asked to identify candidates' potential uterus donor. Altruistic donors, or women who want to donate without knowing a potential recipient, may also participate. All potential donors will be screened to see if the donors are a good match for a recipient and are healthy enough to have the donation surgery.
Study Duration:
Full description
This is a prospective clinical cohort study to establish temporary allogenic uterus transplantation as a feasible and effective reconstructive strategy for the treatment of uterine factor infertility.
Suitable candidates will proceed through as many as nine study stages:
Potential participants will first be screened by phone for general eligibility, motivations for transplantation, and probable identification of a living donor. Potential donors will be interviewed by an Independent Living Donor Advocate to determine eligibility. Suitable candidates and candidates' potential living donors will then undergo blood work screening to determine if it's an acceptable pairing for donation and transplantation. Next, if the recipient does not already have embryos banked at a Johns Hopkins Hospital facility, she will participate in IVF and embryo cryopreservation per standard of care protocols. After a sufficient number of fertilized embryos have been successfully stored, the participant and her living donor will undergo full study screening. Donor/recipient pairs deemed suitable for transplantation based on screening results will be scheduled for and undergo transplant surgery. Post-uterus donation, the donor will be followed according to post-hysterectomy surgery patient care protocols. Post transplantation, the recipient will continue under the care of the study team as a transplant patient as well as under the care of gynecologists, obstetricians, and maternal fetal medicine experts. Depending on the transplant recipient's post-operative course, embryo transfer may be attempted as early as 2 months post-transplant. Should the patient become pregnant, obstetrics will follow the participant's and her fetus' progress. Whether or not the recipient successfully carries a pregnancy or births a child, uterus explantation is an anticipated endpoint of this protocol. Patients will be counseled that participants may have the transplant to birth up to two offspring or for about five years, whichever comes first, after which removal of the uterus should be considered.
Study data on uterus transplant recipients will be collected for 5 years post-transplantation under this protocol, or for the entire time the participant has the graft, plus five years post-explantation. All attempts will be made to collect data on the offspring born as a result of this protocol through the offspring's 21st birthday.
Enrollment
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Inclusion and exclusion criteria
INCLUSION CRITERIA -
Recipient Inclusion Criteria:
Genotypic female of any race, color, or ethnicity.
Uterine factor infertility.
Aged 18-38 years at time of egg retrieval.
Strong desire to undergo uterus transplant in order to become pregnant and give birth to a child.
Embryo cryopreservation with embryos located at Johns Hopkins:
OR o Is willing to undergo egg retrieval, in vitro fertilization, and PGS-screening to cryopreserve a minimum of 4-8 normal embryos.
Donor Inclusion Criteria:
Donor and Recipient Inclusion Criteria:
USA citizen or equivalent.
No co-existing psycho-social problems (i.e., alcoholism, drug abuse).
BMI ≤35
o A higher BMI may be accepted at the discretion of the study team.
Negative for HIV at transplant.
Negative for malignancy for past 5 years.
EXCLUSION CRITERIA-
Donor and Recipient Exclusion Criteria:
Positive for any of the following conditions:
Sensitized recipients with high levels (50%) of panel-reactive Human Leukocyte Antigens (HLA) antibodies.
Conditions that may impact the success of the surgical procedure or increase the risk of postoperative complications including inherited coagulopathies like Hemophilia, Von-Willebrand's disease, Protein C and S deficiency, Thrombocythemias, Thalassemias, Sickle Cell disease, etc.
Mixed connective tissue diseases and collagen diseases that can result in poor wound healing after surgery.
Severe neurologic deficits.
Patients considered unsuitable per the consulted Psychiatric/Psychologic appraisal.
A history of medical non-compliance.
Donor Only Exclusion Criteria:
Recipient Only Exclusion Criteria:
• Conditions that, in the opinion of the study team, may expose the recipient to unacceptable risks under immunosuppressive treatment.
Primary purpose
Allocation
Interventional model
Masking
40 participants in 1 patient group
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Central trial contact
Jane Littleton, CRNP, MSN
Data sourced from clinicaltrials.gov
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