Uterus Transplantation Procedure From a Live Donor

NCT04314869 | Unknown

• 1 other identifier: TUX2020
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Absolut uterine factor, meaning the absence of uterus, represents a cause for sterility without the possibility of a present treatment. The uterine factor affects millions of women and may be due to congenital problems, such as the Muller anomalies (Mayer Rockitansky Syndrome) or acquired by previous hysterectomy or intrauterine adhesions (Asherman's Syndrome). The uterine transplant would represent the only possibility for patients with an absolute uterine factor to achieve both genetic and gestational maternity.

Conditions

Rokitansky Kuster Hauser Syndrome; Sterility, Female

Keywords

minimally invasive surgery; uterus transplantation; living donor; absolut uterine factor

Outcome Measures

Primary Outcomes (1)

• Number of grafts obtained by laparoscopy

  It is feasible to obtain the graft by laparoscopy

  2 years

Secondary Outcomes (1)

• Number of healthy newborns

  5 years

Study Arms (1)

Recipient

EXPERIMENTAL

Patient with absolut uterine factor will undergo uterus transplantation.

Procedure: Uterus transplantation

Interventions

Uterus transplantation PROCEDURE

Patient will undergo surgery in order to transplant the graft (uterus). After that, a follow-up in order to detect early rejection. After 6 months, embryo transfer will be perfomed. Labour route will be C-Section. Two pregnancies are agreed, and after the second one, a hysterectomy will be performed in order to remove the graft.

Also known as: Ovarian estimulation, Immunosupression treatment, Embryo transfer, C-section

Recipient

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: It is a uterus transplantation program, it only includes women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with sterility for absolute uterine factor (malformation or previous surgery for benign processes).
• Age \<40 years.
• Absence of pathology that contraindicates a complex surgical process, immunosuppression or gestation.
• Positive results to the IVF cycle prior to the surgery, obtaining quality embryos.
• Acceptance to participate in the study signing the informed consent.

You may not qualify if:

• Medical or surgical pathology that contraindicates a complex pelvic surgical procedure.
• Medical conditions that contraindicate, may aggravate or complicate the immunosuppressor treatment, such as neoplastic or preneoplasic diseases, chronic infectious diseases, autoimmune diseases, renal or liver failure.
• Medical or surgical pathology that contraindicates pregnancy.
• Anatomic alterations or vascular pathology that might difficult the vascular anastomosis: severe endometriosis, pelvic kidney, severe adherence syndrome or others.
• Uncontrolled psychopathology.
• Age \<65 years.
• First- or second-degree relatives.
• Completed reproductive desire.
• History of previous pregnancies and births.
• Absence of associated pathology that contraindicates prolonged and complex laparoscopic surgery (pneumopathies, heart disease, morbid obesity, …).
• Acceptance to participate in the study signing the informed consent
• Potential future pregnancy desire.
• Surgery for the treatment of gender identity disorder.
• Infections: HIV or risk group, HBV-DNA and / or HBsAg positive, positive HCV, active bacterial sepsis, infections with multi-resistant bacteria, active tuberculosis or incomplete treatment of the same, Chagas disease, untreated active viral infections.
• Active malignant cancer of any location, except skin basal cell carcinoma. Treated cancer without current evidence of illness but with a follow-up of less than 5 years.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic

Barcelona, 08036, Spain

RECRUITING

Related Publications (1)

• Diaz-Feijoo B, Rius M, Gracia M, Musquera M, Magaldi M, Peri L, Alcaraz A, Carmona F. Donor robotic-assisted laparoscopy for uterus transplantation. Fertil Steril. 2022 Mar;117(3):651-652. doi: 10.1016/j.fertnstert.2021.11.026. Epub 2022 Jan 17.

  PMID: 35058048 DERIVED

MeSH Terms

Conditions

Mullerian aplasia; Infertility, Female

Interventions

Embryo Transfer; Cesarean Section

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques; Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Francisco Carmona, MD, PhD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariona Rius, MD

CONTACT

932275400; marius@clinic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Gynecology Department

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: March 19, 2020
• Study Start: May 23, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2025
• Last Updated: November 10, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)