Uterus Transplantation: Acceptability of the Procedure in Eligible Patients

This study aims to define the knowledge and acceptability of uterine transplantation in patients suffering from infertility due to congenital or acquired absence of this organ, which are followed up in the U.O.C. of Gynecology and Pathophysiology of Human Reproduction Polyclinic S. Orsola-Malpighi and registered with the Italian Association for Androgen Insensitivity and Similar Conditions-AISIA.

Study Overview

• Status: Active, not recruiting
• Conditions: Focus: Uterus Transplant Procedure; Acceptability of the Uterus Transplantation Procedure

Detailed Description

Absolute infertility from uterine factor (AUFI) is the term used to indicate the condition of women who cannot achieve pregnancy due to congenital or acquired absence of the uterus or the presence of an anatomically or physiologically non-functional utery1.

The causes of AUFI can be classified in primary/congenital (Mayer-Rokitansky-Kuster-Hauser-MRKH syndrome, Complete insensitivity to androgens-CAIS) and secondary/acquired (Asherman syndrome, previous hysterectomy for benign/malignant gynecological pathologies).

This condition was considered without therapeutic options until a few years ago, when the first birth from living donor uterus transplant was obtained (Sweden, 2014)2.

There are many challenges to the transplantation of the uterus:

• Ethical, complex and evolving issues: first of all the acceptability by patients;3
• the definition of inclusion criteria for donors and recipients, based on the results of procedures carried out to date;4
• the presence of the donor: deceased or living, and in the latter the use of minimally invasive surgical techniques5.

Primary objective of the study Define the acceptability of the uterus transplant procedure in the target population through a cross-sectional observational study using a targeted questionnaire.

Secondary objective To assess the knowledge of certain aspects of uterine transplantation among the population affected by SVCD. To identify the opinion and needs of the study population.

Expected results The information will help improve the efficiency and quality of health services for people with SVD.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40138
    • IRCCS Azienda Ospedaliero-Unioversitaria di Bologna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The subjects to be enrolled in the study are patients taken care of at the U.O.C. of Gynecology and Pathophysiology of Human Reproduction Polyclinic S. Orsola-Malpighi and/or registered with the Italian Association for Androgen Insensitivity Syndrome and similar conditions-AISIA.

Description

Inclusion Criteria:

• - age 18-44 years
• patients with AUFI (MRKH, CAIS, previous hysterectomy due to benign/malignant/unfavorable obstetric outcome) and currently under treatment at the U.O.C. of Gynecology and Pathophysiology of Human Reproduction Polyclinic S. Orsola-Malpighi and registered with the Italian Association for Androgen Insensitivity and Similar Conditions-AISIA.
• Informed consent
• Networked electronic device ensuring connection to the platform and subsequent questionnaire filling
• Internet network
• Personal email address, to which the link for filling out the questionnaires will be sent

Exclusion Criteria:

• no exclusion criteria are provided

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire	In detail, the first part of the questionnaire contains a series of questions concerning socio-demographic aspects, pathological and family history, lifestyles, health status and perceived quality of life. In addition, the following structured and validated questionnaire will be required: - Brief Symptom Checklist-BSCL (Scale from 0 to 4)	1 year

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Maria C Meriggiola, MD, IRCCS Bologna

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2021
• Primary Completion (Actual): April 5, 2024
• Study Completion (Estimated): April 5, 2026

Study Registration Dates

• First Submitted: December 30, 2024
• First Submitted That Met QC Criteria: January 28, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Transplantation of the uterus
• Other Study ID Numbers: ACCUTX-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No