Uterine Transplant in Absolute Uterine Infertility (AUIF)
A legfontosabb adatok
- Ki végzi
- Brigham and Women's Hospital
- Hol
- Boston (Egyesült Államok)A helyszín megnézése
- Azonosító
- Állapot
- Visszavonva
- Fázis
- 2/3. fázis
- Kezdés
- 2026. szept.
- Várható befejezés
- 2028. jún.
- A vizsgálat típusa
- Beavatkozással járó
- A vizsgált kezelések
- Uterine Transplant
- A regiszteradat frissítve
- 2026. október 15.
- Miért állt le
- Attempts to renew our protocol have not been accepted. Also, composition of the team and institutional goals have changed.
Ki vehet részt
- Életkor
- 18 év – 40 év
- Nem
- Csak nők
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 35 feltétel megnézéseKevesebb
Ki nem vehet részt
- Active smoking, alcohol use or use of illicit drugs
- Previous pregnancies were carried to term (no miscarriages)
- Active smoking, alcohol use or use of illicit drugs
- Internal scarring from extensive abdominal or pelvic surgery
- Having a condition that would make pregnancy or taking anti rejection medicines too risky
- Active infection: Human Immunodeficiency Virus (HIV) , Tuberculosis, Hepatitis B, Hepatitis C
- History of extensive abdominal or pelvic surgery
- History of abnormal Papanicolaou test (PAP smear) or genital warts
- History of pelvic inflammatory disease; DONOR:Inclusion criteria
- Psychiatric illness
- History of more than 1 Caesarean section
- History of abnormal PAP smear or genital warts
- Hypertension, Coronary artery disease, Chronic Obstructive Lung disease (emphysema) and Diabetes
- Active cancer or incompletely treated cancer
- Active infection including Human Immunodeficiency Disease (HIV) , Tuberculosis, Hepatitis B or Hepatitis C
- Significant history of either blood clots or bleeding tendencies
- Age over 40 up to age 60
- Inability to comply with required treatment (taking pills, having biopsies, frequent appointments )
- Has completed having a family
- Able to take a birth control pill containing estrogen
- Weight reasonable with BMI (Body Mass Index) of 30 or less
- Good social supports
- Cervical or endometrial polyps (growths) or tumors in the uterus muscle
- Evidence of coercion or exchange of money or goods for donating the organ
Egyéb feltételek
- Uterine Transplant Inclusion/Exclusion Criteria
- RECIPIENT:Inclusion Criteria
- Age 18-40
- Clinical evidence of AUFI (Absolute Uterine Factor Infertility)
- Able to produce at least 6 normal embryos by IVF for future use
- Reasonable weight with BMI (Body Mass Index) less than 30
- Normal kidney function
- Able to undergo transplant and be compliant with treatment
- Has stable partner and social supports
- Partner willing to undergo psychological evaluation and receive immunizations as recommended
- Stable home environment to support a child
Helyszínek itt: Egyesült Államok
- Brigham and Women's HospitalBoston, Egyesült Államok
A vizsgálatról
Mit akar kideríteni a vizsgálat
This study will examine the feasibility of initiating a uterine transplant program for Absolute Uterine Factor Infertility (AUFI) at Brigham and Women's Hospital. The investigators plan to screen 30 patients with a goal of enrolling 10 patients. (5 donors and 5 recipients) After careful screening, appropriate candidates will undergo IVF, Uterine Transplantation, Embryo Transfer, Pregnancy and Delivery. Once the uterus is explanted, five years of follow-up is planned.
A vizsgálat csoportja
- Women with AUFIA vizsgált kezelés
Women with AUFI must meet criteria for uterine transplant. In vitro fertilization to obtain 6 (screened) healthy embryos for cryo-preservation precedes uterine transplant from an appropriate donor The recipient will be required to take potent anti rejection medications including Thymoglobulin, Prednisone, Tacrolimus, Mycophenolate Mofetil (MMF) , later substituted with Azathioprine to avoid birth defects. One year later, up to 6 attempts using 1 screened embryo at a time will be tried to achieve pregnancy. During pregnancy, the high risk pregnancy and transplant teams will follow the recipient. The goal is a full term baby and delivery will be by Caesarian section. A second pregnancy may be attempted. Afterward, the uterus will be explanted.
Kezelés: Uterine Transplant
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- A regiszteradat frissítve
- 2026. október 15.