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Enrolling by invitation NCT03048396

Acceptance of Uterus Transplantation

No phase Interventional Resolve Infertility

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: Uterus transplantation.
Who it may be relevant to
Registry conditions: Resolve Infertility. Basic parameters: 20 years — 40 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
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Transplantation of an Uterus for Treatment of an Absolute Uterine Infertility

Overview

Transplantation of an uterus

Detailed description

Uterus transplantation will be performed from live donors to patients with absolute uterine factor infertility. Organ procurement from the donor will be performed by laparotomy. Transplantation will also be performed by laparotomy. Embryo transfer will be done 10-12 months after transplantation. After birth of 1-3 children the uterus will be removed by hysterectomy.

Interventions

  • Procedure Uterus transplantation

Primary outcome measures

  • Number of patients who are interested in an uterus transplantation [Time frame: 3 years]
  • Number of patients from these who do have a potential donor [Time frame: 3 years]
  • Number of patients from these who do have a medical indication for an uterus transplantation [Time frame: 3 years]

Eligibility criteria

Inclusion criteria

  • age below 40 years
  • absolute uterine factor infertility
  • BMI < 30

Exclusion criteria

  • systemic disease
  • psychiatric disease

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
Other

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Brucker SY, Brannstrom M, Taran FA, Nadalin S, Konigsrainer A, Rall K, Scholler D, Henes M, Bosmuller H, Fend F, Nikolaou K, Notohamiprodjo M, Rosenberger P, Grasshoff C, Heim E, Kramer B, Reisenauer C, Hoopmann M, Kagan KO, Dahm-Kahler P, Kvarnstrom N, Wallwiener D. Selecting living donors for uterus transplantation: lessons learned from two transplantations resulting in menstrual functionality a PMID 29270725

Identifiers

NCT: NCT03048396 · FEH_Uterustransplantation

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗