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Uterus Transplantation Procedure From a Live Donor

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ClinicalTrials.gov Identifier: NCT04314869
Recruitment Status : Recruiting
First Posted : March 19, 2020
Last Update Posted : November 10, 2020
Sponsor:
Information provided by (Responsible Party):
Francisco Carmona, Hospital Clinic of Barcelona

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.

Condition or disease Intervention/treatment Phase
Rokitansky Kuster Hauser Syndrome Sterility, Female Procedure: Uterus transplantation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study of Uterus Transplantation Procedure From a Live Donor Obtaining the Graft by Laparoscopy
Actual Study Start Date : May 23, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Recipient
Patient with absolut uterine factor will undergo uterus transplantation.
Procedure: Uterus transplantation
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.
Other Names:
  • Ovarian estimulation
  • Immunosupression treatment
  • Embryo transfer
  • C-section




Primary Outcome Measures :
  1. Number of grafts obtained by laparoscopy [ Time Frame: 2 years ]
    It is feasible to obtain the graft by laparoscopy


Secondary Outcome Measures :
  1. Number of healthy newborns [ Time Frame: 5 years ]
    A healthy newborn after C-section



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   It is a uterus transplantation program, it only includes women.
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04314869


Contacts
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Contact: Mariona Rius, MD 932275400 ext 5436 marius@clinic.cat

Locations
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Spain
Hospital Clinic Recruiting
Barcelona, Spain, 08036
Principal Investigator: Francisco Carmona, PhD         
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
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Principal Investigator: Francisco Carmona, MD, PhD Hospital Clinic of Barcelona
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Responsible Party: Francisco Carmona, Head of Gynecology Department, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT04314869    
Other Study ID Numbers: TUX2020
First Posted: March 19, 2020    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Francisco Carmona, Hospital Clinic of Barcelona:
minimally invasive surgery
uterus transplantation
living donor
absolut uterine factor
Additional relevant MeSH terms:
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Infertility
Infertility, Female