Back to resultsFeasibility Study of Uterine Transplantation From Living Donors in Terms of Efficacy and Safety in Patients With Mayer-Rokitansky-Küster-Hauser Syndrome (MRKH)
Primary Purpose
Mayer Rokitansky Kuster Hauser Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Uterine transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Mayer Rokitansky Kuster Hauser Syndrome
Eligibility Criteria
Inclusion Criteria:
Graft recipient is a patient with Mayer-Rokitansky-Küster-Hauser Type I Uterine Vaginal Agenesis (without renal, cardiac and bone malformations):
- Being aged between 18 and 38 years old
- In stable couple, with a pregnancy project, favorable psychological evaluation
- No history of cancer and transfusion
The living donor is a woman related to the Graft recipient with
- Absence of comorbidity (neurological, nephro-urological pathology, infectious, psychiatric or psychological pathology)
- Absence of uterine surgery, abdomino-pelvic major pathology history
Exclusion Criteria:
Graft recipient:
- Extreme oligo-astheno-spermia and azoospermia in the husband
- History of abdominopelvic surgery excluding uncomplicated appendectomy; vaginal residue not allowing anastomosis
Living donor :
- Known thromboembolic risk factor
- No Compatibility with the recipient (group, rhesus, HLA)
Sites / Locations
- Hopital FochRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Couple donor - recipient
Arm Description
Outcomes
Primary Outcome Measures
Pregnancy
Obtaining of a pregnancy after uterine transplantation from a living donor
Secondary Outcome Measures
Safety assessment of the donor, the recipient and the fœtus
Monitoring of all the Adverse events
Psychological assessment of the donor and the recipient
Psychological consequences linked to the procedure determined by repeated interviews with psychologists
Graft Rejection assessment
Donor-specific antobodies monitoring
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03689842
Brief Title
Feasibility Study of Uterine Transplantation From Living Donors in Terms of Efficacy and Safety in Patients With Mayer-Rokitansky-Küster-Hauser Syndrome (MRKH)
Official Title
Feasibility Study of Uterine Transplantation From Living Donors in Terms of Efficacy and Safety in Patients With Mayer-Rokitansky-Küster-Hauser Syndrome (MRKH)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2017 (Actual)
Primary Completion Date
December 14, 2024 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In France, one in 4500 women is affected by the MayerRokitantskyKüsterHauser (MRKH) syndrome which is characterized by the absence of uterus at birth. Currently, the only solutions for these patients are:
Gestational surrogacy, prohibited in France
Adoption
Resignation
Uterine transplantation could become a good alternative.
This study is conducted in 10 patients with MRKH type I syndrome, who will be transplanted from a living donor uterus
Detailed Description
The aim of the study is to obtain a pregnancy after uterine transplantation from a living donor. Also, this study will assess (anatomically and functionally) the issue of the transplants of a uterus taken from a living donor and the safety of the living donor (functionally and psychologically)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mayer Rokitansky Kuster Hauser Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Couple donor - recipient
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Uterine transplantation
Intervention Description
Uterine transplantation from living donor
Primary Outcome Measure Information:
Title
Pregnancy
Description
Obtaining of a pregnancy after uterine transplantation from a living donor
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Safety assessment of the donor, the recipient and the fœtus
Description
Monitoring of all the Adverse events
Time Frame
7 years
Title
Psychological assessment of the donor and the recipient
Description
Psychological consequences linked to the procedure determined by repeated interviews with psychologists
Time Frame
7 years
Title
Graft Rejection assessment
Description
Donor-specific antobodies monitoring
Time Frame
5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Graft recipient is a patient with Mayer-Rokitansky-Küster-Hauser Type I Uterine Vaginal Agenesis (without renal, cardiac and bone malformations):
Being aged between 18 and 38 years old
In stable couple, with a pregnancy project, favorable psychological evaluation
No history of cancer and transfusion
The living donor is a woman related to the Graft recipient with
Absence of comorbidity (neurological, nephro-urological pathology, infectious, psychiatric or psychological pathology)
Absence of uterine surgery, abdomino-pelvic major pathology history
Exclusion Criteria:
Graft recipient:
Extreme oligo-astheno-spermia and azoospermia in the husband
History of abdominopelvic surgery excluding uncomplicated appendectomy; vaginal residue not allowing anastomosis
Living donor :
Known thromboembolic risk factor
No Compatibility with the recipient (group, rhesus, HLA)
Facility Information:
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Marc Ayoubi, MD PhD
Phone
+33(0)146252339
Email
jm.ayoubi@hopital-foch.org
First Name & Middle Initial & Last Name & Degree
Jean-Marc Ayoubi, MD PhD
First Name & Middle Initial & Last Name & Degree
René Frydman, MD PhD
First Name & Middle Initial & Last Name & Degree
Marie Carbonnel, MD
First Name & Middle Initial & Last Name & Degree
Aurélie Revaux, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25593933
Citation
Goetgheluck J, Carbonnel M, Ayoubi JM. Robotically assisted gynecologic surgery: 2-year experience in the French foch hospital. Front Surg. 2014 May 5;1:8. doi: 10.3389/fsurg.2014.00008. eCollection 2014.
Results Reference
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PubMed Identifier
25301505
Citation
Brannstrom M, Johannesson L, Bokstrom H, Kvarnstrom N, Molne J, Dahm-Kahler P, Enskog A, Milenkovic M, Ekberg J, Diaz-Garcia C, Gabel M, Hanafy A, Hagberg H, Olausson M, Nilsson L. Livebirth after uterus transplantation. Lancet. 2015 Feb 14;385(9968):607-616. doi: 10.1016/S0140-6736(14)61728-1. Epub 2014 Oct 6.
Results Reference
background
PubMed Identifier
23936645
Citation
Carbonnel M, Abbou H, N'guyen HT, Roy S, Hamdi G, Jnifen A, Ayoubi JM. Robotically Assisted Hysterectomy versus Vaginal Hysterectomy for Benign Disease: A Prospective Study. Minim Invasive Surg. 2013;2013:429105. doi: 10.1155/2013/429105. Epub 2013 Jul 7.
Results Reference
background
PubMed Identifier
29391294
Citation
Gauthier T, Lavoue V, Piver P, Aubard Y, Ayoubi JM, Garbin O, Agostini A, Collinet P, Morcel K; Comite d'etude de la Transplantation Uterine en France (CETUF) du CNGOF. Which neovagina reconstruction procedure for women with Mayer-Rokitansky-Kuster-Hauser syndrome in the uterus transplantation era? Editorial from the French Uterus Transplantation Committee (CETUF) of CNGOF. J Gynecol Obstet Hum Reprod. 2018 Apr;47(4):175-176. doi: 10.1016/j.jogoh.2018.01.003. Epub 2018 Jan 31. No abstract available.
Results Reference
background
PubMed Identifier
21401629
Citation
Grynberg M, Ayoubi JM, Bulletti C, Frydman R, Fanchin R. Uterine transplantation: a promising surrogate to surrogacy? Ann N Y Acad Sci. 2011 Mar;1221:47-53. doi: 10.1111/j.1749-6632.2011.05952.x.
Results Reference
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Feasibility Study of Uterine Transplantation From Living Donors in Terms of Efficacy and Safety in Patients With Mayer-Rokitansky-Küster-Hauser Syndrome (MRKH)
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