NCT03689842

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
105mo left

Started Dec 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Dec 2017Dec 2034

Study Start

First participant enrolled

December 14, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 28, 2018

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2027

Expected
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2034

Last Updated

March 7, 2025

Status Verified

March 1, 2025

Enrollment Period

10 years

First QC Date

July 13, 2018

Last Update Submit

March 4, 2025

Conditions

Mayer Rokitansky Kuster Hauser Syndrome

Outcome Measures

Primary Outcomes (1)

  • Pregnancy

    Obtaining of a pregnancy after uterine transplantation from a living donor

    3 years

Secondary Outcomes (3)

  • Safety assessment of the donor, the recipient and the fœtus

    7 years

  • Psychological assessment of the donor and the recipient

    7 years

  • Graft Rejection assessment

    5 years

Study Arms (1)

Couple donor - recipient

EXPERIMENTAL
Procedure: Uterine transplantation

Interventions

Uterine transplantationPROCEDURE

Uterine transplantation from living donor

Couple donor - recipient

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Foch

Suresnes, 92150, France

RECRUITING

Related Publications (5)

  • 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: 25593933BACKGROUND

  • 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: 25301505BACKGROUND

  • 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: 23936645BACKGROUND

  • 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.

    PMID: 29391294BACKGROUND

  • 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: 21401629BACKGROUND

MeSH Terms

Conditions

Mullerian aplasia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2018

First Posted

September 28, 2018

Study Start

December 14, 2017

Primary Completion (Estimated)

December 14, 2027

Study Completion (Estimated)

December 14, 2034

Last Updated

March 7, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)