Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05726305
Status:
RECRUITING
Last Update Posted:
2024-01-26
First Post:
2023-02-03
Brief Title:
Transplantation of Uterus for Uterine infertiLIty From Living Donor or Deceased Donor
Sponsor:
Rennes University Hospital
Organization:
Rennes University Hospital
Study Overview
Official Title:
Transplantation of Uterus for Uterine infertiLIty From Living Donor or Deceased Donor
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TULIPE
Brief Summary:
Patients with absolute Uterine Factor Infertility AUFI are infertile due to the absence of a uterus The absence of a uterus can be either iatrogenic hysterectomy for gynecological pathology such as cancer or for obstetric pathology such as postpartum hemorrhage with hysterectomy for hemostasis or congenital with utero-vaginal agenesis including Mayer Rokitansky Küster Hauser syndrome MRKH is the most common syndrome of uterine agenesis
Alongside the AUFI there is Non-Absolute Uterine Factor Infertility NAUFI which corresponds to patients with a uterus in place but which is altered by different pathologies most often acquired making it unsuitable for embryonic implantation and preventing the patient to get pregnant
Uterus Transplantation UT represents an interesting alternative to the treatment of AUFI and potentially NAUFI in the event of a uterus present but unsuitable for implantation to access parenthood especially since it is the only proposal that allows the patient to be both the surrogate mother the biological mother in case of simple donation and the legal mother
Many animal experiments have been accelerated since the beginning of the 21st century demonstrating that uterus transplantation was technically feasible and that pregnancy was possible
In humans several teams have recently performed several uterus transplants and have shown that this procedure is possible whether the donor is alive or dead state of brain death
In France two teams Foch and Limoges have developed a uterus transplantation program One in the context of living donors and the other of a deceased donors
At the University Hospital of Rennes we want to offer a UT program allowing access to a living or deceased donor for women with AUFI type 1 or 2 MRKH syndrome and hysterectomy
Alongside the AUFI there is Non-Absolute Uterine Factor Infertility NAUFI which corresponds to patients with a uterus in place but which is altered by different pathologies most often acquired making it unsuitable for embryonic implantation and preventing the patient to get pregnant
Uterus Transplantation UT represents an interesting alternative to the treatment of AUFI and potentially NAUFI in the event of a uterus present but unsuitable for implantation to access parenthood especially since it is the only proposal that allows the patient to be both the surrogate mother the biological mother in case of simple donation and the legal mother
Many animal experiments have been accelerated since the beginning of the 21st century demonstrating that uterus transplantation was technically feasible and that pregnancy was possible
In humans several teams have recently performed several uterus transplants and have shown that this procedure is possible whether the donor is alive or dead state of brain death
In France two teams Foch and Limoges have developed a uterus transplantation program One in the context of living donors and the other of a deceased donors
At the University Hospital of Rennes we want to offer a UT program allowing access to a living or deceased donor for women with AUFI type 1 or 2 MRKH syndrome and hysterectomy
Detailed Description:
Methods Sixteen UT will be performed in total in 2 parallel arms 8 UT from a live donor and 8 UT from a deceased brain-dead donor Patients who have no suitable live donor will be wait-listed for a deceased donor
Phases of the UT procedure selection in vitro fertilization and cryopreservation of embryos uterus retrieval from a live donor or from a deceased donor orthotopic uterus transplantation follow up period 12 months embryo transfer pregnancy child birth via Cesarian section 2 children maximum later graft hysterectomy
Phases of the UT procedure selection in vitro fertilization and cryopreservation of embryos uterus retrieval from a live donor or from a deceased donor orthotopic uterus transplantation follow up period 12 months embryo transfer pregnancy child birth via Cesarian section 2 children maximum later graft hysterectomy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None