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Uterus Transplantation Procedure From a Live Donor

Primary Purpose

Rokitansky Kuster Hauser Syndrome, Sterility, Female

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Uterus transplantation
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rokitansky Kuster Hauser Syndrome focused on measuring minimally invasive surgery, uterus transplantation, living donor, absolut uterine factor

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria Recipient:

  • Patient with sterility for absolute uterine factor (malformation or previous surgery for benign processes).
  • Age <40 years.
  • Absence of pathology that contraindicates a complex surgical process, immunosuppression or gestation.
  • Positive results to the IVF cycle prior to the surgery, obtaining quality embryos.
  • Acceptance to participate in the study signing the informed consent.

Exclusion Criteria Recipient:

  • Medical or surgical pathology that contraindicates a complex pelvic surgical procedure.
  • Medical conditions that contraindicate, may aggravate or complicate the immunosuppressor treatment, such as neoplastic or preneoplasic diseases, chronic infectious diseases, autoimmune diseases, renal or liver failure.
  • Medical or surgical pathology that contraindicates pregnancy.
  • Anatomic alterations or vascular pathology that might difficult the vascular anastomosis: severe endometriosis, pelvic kidney, severe adherence syndrome or others.
  • Uncontrolled psychopathology.

Inclusion Criteria donor:

  • Age <65 years.
  • First- or second-degree relatives.
  • Completed reproductive desire.
  • History of previous pregnancies and births.
  • Absence of associated pathology that contraindicates prolonged and complex laparoscopic surgery (pneumopathies, heart disease, morbid obesity, …).
  • Acceptance to participate in the study signing the informed consent

Exclusion Criteria donor:

  • Potential future pregnancy desire.
  • Surgery for the treatment of gender identity disorder.
  • Infections: HIV or risk group, HBV-DNA and / or HBsAg positive, positive HCV, active bacterial sepsis, infections with multi-resistant bacteria, active tuberculosis or incomplete treatment of the same, Chagas disease, untreated active viral infections.
  • Active malignant cancer of any location, except skin basal cell carcinoma. Treated cancer without current evidence of illness but with a follow-up of less than 5 years.
  • Benign pelvic pathology: uterine fibroids, uterine malformations, severe endometriosis, severe adherence syndrome.
  • Vascular pathology: malformations, atheromatosis, hypertensive or diabetic vasculopathy, connective tissue disease with vascular involvement.
  • Premalignant pelvic pathology: pre-invasive cervical and/or vaginal, endometrial hyperplasia.
  • BRCA mutation carriers or genes related to Lynch syndrome.
  • History of implantation failure or multiple abortions of unknown cause.
  • Contraindications for the surgical procedure of donation through laparoscopy: diabetes mellitus, liver disease, nephropathy, heart disease, pneumopathy, morbid obesity or high-risk cardiovascular factors.

Sites / Locations

  • Hospital ClinicRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Recipient

Arm Description

Patient with absolut uterine factor will undergo uterus transplantation.

Outcomes

Primary Outcome Measures

Number of grafts obtained by laparoscopy
It is feasible to obtain the graft by laparoscopy

Secondary Outcome Measures

Number of healthy newborns
A healthy newborn after C-section

Full Information

First Posted
March 17, 2020
Last Updated
November 7, 2020
Sponsor
Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT04314869
Brief Title
Uterus Transplantation Procedure From a Live Donor
Official Title
Feasibility Study of Uterus Transplantation Procedure From a Live Donor Obtaining the Graft by Laparoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Absolut uterine factor, meaning the absence of uterus, represents a cause for sterility without the possibility of a present treatment. The uterine factor affects millions of women and may be due to congenital problems, such as the Muller anomalies (Mayer Rockitansky Syndrome) or acquired by previous hysterectomy or intrauterine adhesions (Asherman's Syndrome). The uterine transplant would represent the only possibility for patients with an absolute uterine factor to achieve both genetic and gestational maternity.
Detailed Description
To obtain by laparoscopy a viable uterus for transplantation from a living donor is feasible. The laparoscopic procedure increases safety and provides the benefits of minimally invasive surgery to the grafting technique already described by laparotomy. The objective of the present study is to develop a pilot program in the transplant of a living donor. We include 5 pairs of uterine donor-transplant recipients indicated for sterility by absolute uterine factor due to Mayer Rokitansky Syndrome. Patients will undergo surgery for this transplant and after 6 months of it with correct function of the graft, embryos will be transferred in order to achieve pregnancy. C-section will be performed for delivery. The attempt of two gestations (if there are sufficient cryopreserved embryos for a second gestation) and withdrawing the graft (hysterectomy) and, therefore, immunosuppression is agreed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rokitansky Kuster Hauser Syndrome, Sterility, Female
Keywords
minimally invasive surgery, uterus transplantation, living donor, absolut uterine factor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Recipient
Arm Type
Experimental
Arm Description
Patient with absolut uterine factor will undergo uterus transplantation.
Intervention Type
Procedure
Intervention Name(s)
Uterus transplantation
Other Intervention Name(s)
Ovarian estimulation, Immunosupression treatment, Embryo transfer, C-section
Intervention Description
Patient will undergo surgery in order to transplant the graft (uterus). After that, a follow-up in order to detect early rejection. After 6 months, embryo transfer will be perfomed. Labour route will be C-Section. Two pregnancies are agreed, and after the second one, a hysterectomy will be performed in order to remove the graft.
Primary Outcome Measure Information:
Title
Number of grafts obtained by laparoscopy
Description
It is feasible to obtain the graft by laparoscopy
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Number of healthy newborns
Description
A healthy newborn after C-section
Time Frame
5 years

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
It is a uterus transplantation program, it only includes women.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Recipient: Patient with sterility for absolute uterine factor (malformation or previous surgery for benign processes). Age <40 years. Absence of pathology that contraindicates a complex surgical process, immunosuppression or gestation. Positive results to the IVF cycle prior to the surgery, obtaining quality embryos. Acceptance to participate in the study signing the informed consent. Exclusion Criteria Recipient: Medical or surgical pathology that contraindicates a complex pelvic surgical procedure. Medical conditions that contraindicate, may aggravate or complicate the immunosuppressor treatment, such as neoplastic or preneoplasic diseases, chronic infectious diseases, autoimmune diseases, renal or liver failure. Medical or surgical pathology that contraindicates pregnancy. Anatomic alterations or vascular pathology that might difficult the vascular anastomosis: severe endometriosis, pelvic kidney, severe adherence syndrome or others. Uncontrolled psychopathology. Inclusion Criteria donor: Age <65 years. First- or second-degree relatives. Completed reproductive desire. History of previous pregnancies and births. Absence of associated pathology that contraindicates prolonged and complex laparoscopic surgery (pneumopathies, heart disease, morbid obesity, …). Acceptance to participate in the study signing the informed consent Exclusion Criteria donor: Potential future pregnancy desire. Surgery for the treatment of gender identity disorder. Infections: HIV or risk group, HBV-DNA and / or HBsAg positive, positive HCV, active bacterial sepsis, infections with multi-resistant bacteria, active tuberculosis or incomplete treatment of the same, Chagas disease, untreated active viral infections. Active malignant cancer of any location, except skin basal cell carcinoma. Treated cancer without current evidence of illness but with a follow-up of less than 5 years. Benign pelvic pathology: uterine fibroids, uterine malformations, severe endometriosis, severe adherence syndrome. Vascular pathology: malformations, atheromatosis, hypertensive or diabetic vasculopathy, connective tissue disease with vascular involvement. Premalignant pelvic pathology: pre-invasive cervical and/or vaginal, endometrial hyperplasia. BRCA mutation carriers or genes related to Lynch syndrome. History of implantation failure or multiple abortions of unknown cause. Contraindications for the surgical procedure of donation through laparoscopy: diabetes mellitus, liver disease, nephropathy, heart disease, pneumopathy, morbid obesity or high-risk cardiovascular factors.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mariona Rius, MD
Phone
932275400
Ext
5436
Email
marius@clinic.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Carmona, MD, PhD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco Carmona, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We will not share individual participant data, but we will publish all the results and protocols so other researchers have access to this information
Citations:
PubMed Identifier
35058048
Citation
Diaz-Feijoo B, Rius M, Gracia M, Musquera M, Magaldi M, Peri L, Alcaraz A, Carmona F. Donor robotic-assisted laparoscopy for uterus transplantation. Fertil Steril. 2022 Mar;117(3):651-652. doi: 10.1016/j.fertnstert.2021.11.026. Epub 2022 Jan 17.
Results Reference
derived

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Uterus Transplantation Procedure From a Live Donor

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