Feasibility Study of Uterine Transplantation From Living Donors in Terms of Efficacy and Safety in Patients With Mayer-Rokitansky-Küster-Hauser Syndrome (MRKH)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Uterine transplantation.
- Who it may be relevant to
- Registry conditions: Mayer Rokitansky Kuster Hauser Syndrome. Basic parameters: 18 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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)
Interventions
- Procedure Uterine transplantation
Uterine transplantation from living donor
Primary outcome measures
- Pregnancy [Time frame: 3 years]
Secondary outcome measures (3)
- Safety assessment of the donor, the recipient and the fœtus [Time frame: 7 years]
- Psychological assessment of the donor and the recipient [Time frame: 7 years]
- Graft Rejection assessment [Time frame: 5 years]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- Hopital Foch — Suresnes
Publications
- 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. PMID 25593933
- 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. PMID 25301505
- 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. PMID 23936645
- 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 Re PMID 29391294
- 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. PMID 21401629
Identifiers
NCT: NCT03689842 · 2016/26