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Uterus Transplantation: Acceptability of the Procedure in Eligible Patients

Uterus Transplantation: Acceptability of the Procedure in Eligible Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06799728
Enrollment
150
Registered
2025-01-29
Start date
2021-04-05
Completion date
2026-04-05
Last updated
2025-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acceptability of the Uterus Transplantation Procedure, Focus: Uterus Transplant Procedure

Keywords

Transplantation of the uterus

Brief summary

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.

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.

Interventions

None listed

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Questionnaire1 yearIn 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)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026