Clinical trial NCT06799728: Uterus Transplantation: Acceptability of the Procedure in Eligible Patients
Official title: Uterus Transplantation: Acceptability of the Procedure in Eligible Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Focus: Uterus Transplant Procedure
Acceptability of the Uterus Transplantation Procedure
Keywords: Transplantation of the uterus
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Questionnaire
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Unioversitaria di Bologna
Study officials:
affiliation: IRCCS Bologna
name: Maria C Meriggiola, MD
role: PRINCIPAL_INVESTIGATOR
References: