Avliden livmodertransplantation vid absolut uterin infertilitet (AUIF)
Our study will explore the feasibility of initiating a deceased donor uterine transplant program in addition to the existing living donor IRB at BWH.
Using the template established by teams around the world, we will identify emotionally and socially stable females of reproductive age with intact ovaries who are unable to gestate a child due to congenital or acquired uterine factor infertility. After careful screening, participants will undergo egg harvest, in vitro fertilization, and embryo cryopreservation using standard methods. Women who successfully complete the fertilization of at least six euploid embryos will be eligible to be placed on the waitlist for a deceased donor uterus transplant. After a successful transplant and a period of observation to ensure normal menstrual cycle and graft viability (anticipate six months), embryo implantation will be undertaken.
Following an embryo transfer, gestation will be carefully monitored by our high-risk pregnancy specialists. Medical research interventions include the surgical implantation of a uterus utilizing techniques by teams that have applied this approach successfully, close post-transplant follow up including immunosuppression therapy tailored to established standards during pregnancy minimizing fetal risks, and careful management of pregnancy. After childbearing is complete (at most two gestations), the donor uterus will be removed either during Cesarean or during an elective procedure. In addition, open ended interviews and surveys will be conducted to elicit ethical and psychosocial concerns arising from the experience of subjects and their families, health care providers, and the wider community. The investigator's intent is to monitor outcomes for transplant recipients as well as the live born infants for 30 days after removal of the transplanted uterus.
It is estimated that the time from screening to a potential live birth will be a minimum of 22 months, but likely between 24 - 36 months depending on organ availability.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Stefan G Tullius, MD
- Telefonnummer: 617-732-6866
- E-post: stullius@bwh.harvard.edu
Studera Kontakt Backup
- Namn: Shannon Weiss
- Telefonnummer: 617-525-9763
- E-post: sweiss3@bwh.harvard.edu
Studieorter
-
-
Massachusetts
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Boston, Massachusetts, Förenta staterna, 02115
- Rekrytering
- Brigham & Women's Hospital
-
Kontakt:
- Stefan Tullius, MD
- Telefonnummer: 617-697-9294
- E-post: stullius@bwh.harvard.edu
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Evidence of AUFI diagnosed by BWH gynecologist
- Ability to produce at least 6 euploid embryos for cryopreservation
- BMI ≤ 30
- GFR 60 or greater in any patient including those with a single kidney
- PRA 20% or less
- Deemed stable and capable of undergoing transplant by the transplant team to include psychiatry, social work, and transplant coordinator and study doctors to assure compliance with treatment
- Evidence to be compliant with follow-up and immunosuppression
- Partner willing to undergo psychological evaluation and receive immunizations as recommended
- Stable home environment to support a child
Exclusion Criteria:
- Active smoking, alcohol use or use of illicit drugs
- Inability to follow a strict medication dosing schedule post-transplant and adhere to required follow-up appointments.
- Any co-morbidities which would increase surgical risk, risk of pregnancy or the risk of taking anti-rejection medications as determined by the Maternal Fetal Specialist and Transplant Surgeon.
- Active infection: HIV, Hepatitis B, Hepatitis C
- Inadequate blood vessels to support the transplanted uterus.
- Prior extensive abdominal or pelvic surgery
- Presence of pelvic kidney
- History of abnormal PAP
- HPV related vulvar, vaginal or cervical dysplasia
- Evidence of genital condylomata
- History of PID
- One or more living biological children
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Livmodertransplantation från avliden donator
|
The recipient will be started on anti-rejection medications (as is routine for transplant recipients) prior to the OR. Standard of care anesthesia and line placement will take place. The recipient will be appropriately identified as an organ recipient and the donor organ identified per required transplant protocols already in place. The recipient team will then connect the vasculature and appropriate supporting structures for the uterus transplant. Once the organ has been re-perfused, the remainder of the operation will take place and the patient will be moved to the Intensive Care Unit and later to the transplant patient floor for standard monitoring. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Live Births Following Uterus Transplant
Tidsram: Within 5 years of transplant
|
To provide motherhood options for women with AUIF as an alternative to surrogacy or adoption, via gestating and giving birth via Cesarean section to a live infant. |
Within 5 years of transplant
|
|
Number of Surgically Successful Uterus Transplants
Tidsram: Within 3 months of transplant
|
To achieve surgically successful uterus transplants. |
Within 3 months of transplant
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Financial impact of deceased donor uterus transplantation
Tidsram: Through Study completion, up to 5 years post transplant
|
To analyze the overall impact of deceased donor uterus transplantation costs relative to established alternative procedures such as adoption and surrogacy. |
Through Study completion, up to 5 years post transplant
|
|
Quality of life impact of deceased donor uterus transplantation
Tidsram: Through study completion, up to 5 years post transplant
|
To analyze the overall impact of deceased donor uterus transplantation including changes in quality of life, relative to other established alternative procedures such as adoption and surrogacy. |
Through study completion, up to 5 years post transplant
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Stefan G Tullius, MD, Brigham and Women's Hospital
Publikationer och användbara länkar
Allmänna publikationer
- Brannstrom M, Johannesson L, Dahm-Kahler P, Enskog A, Molne J, Kvarnstrom N, Diaz-Garcia C, Hanafy A, Lundmark C, Marcickiewicz J, Gabel M, Groth K, Akouri R, Eklind S, Holgersson J, Tzakis A, Olausson M. First clinical uterus transplantation trial: a six-month report. Fertil Steril. 2014 May;101(5):1228-36. doi: 10.1016/j.fertnstert.2014.02.024. Epub 2014 Feb 27.
- Tullius SG, Rudolf JA, Malek SK. Moving boundaries--the Nightingale twins and transplantation science. N Engl J Med. 2012 Apr 26;366(17):1564-5. doi: 10.1056/NEJMp1114193. No abstract available.
- Lefkowitz A, Edwards M, Balayla J. The Montreal Criteria for the Ethical Feasibility of Uterine Transplantation. Transpl Int. 2012 Apr;25(4):439-47. doi: 10.1111/j.1432-2277.2012.01438.x. Epub 2012 Feb 23.
- Del Priore G, Saso S, Meslin EM, Tzakis A, Brannstrom M, Clarke A, Vianna R, Sawyer R, Smith JR. Uterine transplantation--a real possibility? The Indianapolis consensus. Hum Reprod. 2013 Feb;28(2):288-91. doi: 10.1093/humrep/des406. Epub 2012 Nov 30.
- McKay DB, Josephson MA. Pregnancy in recipients of solid organs--effects on mother and child. N Engl J Med. 2006 Mar 23;354(12):1281-93. doi: 10.1056/NEJMra050431. No abstract available.
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 2018P001782/PHS
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Data will be published or presented at scientific meetings or distributed upon request.
Tidsram för IPD-delning
For the duration of the study.
Kriterier för IPD Sharing Access
Data will be published or presented at scientific meetings or distributed upon request.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- ICF
- CSR
Läkemedels- och apparatinformation, studiedokument
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