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Avdød livmortransplantasjon ved absolutt uterin infertilitet (AUIF)

25. september 2026 oppdatert av: Stefan G Tullius, Brigham and Women's Hospital

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

250

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02115
        • Rekruttering
        • Brigham & Women's Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 40 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Livmortransplantasjon fra avdød donor
Fremgangsmåte: Uterine Transplant from Deceased Donor

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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Live Births Following Uterus Transplant
Tidsramme: 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
Tidsramme: Within 3 months of transplant

To achieve surgically successful uterus transplants.
Within 3 months of transplant

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Financial impact of deceased donor uterus transplantation
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Brigham and Women's Hospital

Etterforskere

  • Hovedetterforsker: Stefan G Tullius, MD, Brigham and Women's Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. oktober 2026

Primær fullføring (Antatt)

1. desember 2027

Studiet fullført (Antatt)

1. januar 2028

Datoer for studieregistrering

Først innsendt

2. mai 2019

Først innsendt som oppfylte QC-kriteriene

18. juli 2019

Først lagt ut (Faktiske)

19. juli 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 2018P001782/PHS

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Data will be published or presented at scientific meetings or distributed upon request.

IPD-delingstidsramme

For the duration of the study.

Tilgangskriterier for IPD-deling

Data will be published or presented at scientific meetings or distributed upon request.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • ICF
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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