Uterus Transplantation Procedure From a Live Donor

NCT ID: NCT04314869

Last Updated: 2020-11-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-23
• Study Completion Date: 2025-12-31

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.

Detailed Description

To obtain by laparoscopy a viable uterus for transplantation from a living donor is feasible. The laparoscopic procedure increases safety and provides the benefits of minimally invasive surgery to the grafting technique already described by laparotomy. The objective of the present study is to develop a pilot program in the transplant of a living donor. We include 5 pairs of uterine donor-transplant recipients indicated for sterility by absolute uterine factor due to Mayer Rokitansky Syndrome. Patients will undergo surgery for this transplant and after 6 months of it with correct function of the graft, embryos will be transferred in order to achieve pregnancy. C-section will be performed for delivery. The attempt of two gestations (if there are sufficient cryopreserved embryos for a second gestation) and withdrawing the graft (hysterectomy) and, therefore, immunosuppression is agreed.

Conditions

Rokitansky Kuster Hauser Syndrome; Sterility, Female

Keywords

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Recipient

Patient with absolut uterine factor will undergo uterus transplantation.

Group Type: EXPERIMENTAL

Uterus transplantation

Intervention Type: 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.

Interventions

Uterus transplantation

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.

Intervention Type: PROCEDURE

Other Intervention Names

Ovarian estimulation; Immunosupression treatment; Embryo transfer; C-section

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

Exclusion Criteria

• 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.

• 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.
• Benign pelvic pathology: uterine fibroids, uterine malformations, severe endometriosis, severe adherence syndrome.
• Vascular pathology: malformations, atheromatosis, hypertensive or diabetic vasculopathy, connective tissue disease with vascular involvement.
• Premalignant pelvic pathology: pre-invasive cervical and/or vaginal, endometrial hyperplasia.
• BRCA mutation carriers or genes related to Lynch syndrome.
• History of implantation failure or multiple abortions of unknown cause.
• Contraindications for the surgical procedure of donation through laparoscopy: diabetes mellitus, liver disease, nephropathy, heart disease, pneumopathy, morbid obesity or high-risk cardiovascular factors.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Francisco Carmona

Head of Gynecology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francisco Carmona, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Locations

Hospital Clinic

Barcelona, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Mariona Rius, MD

Role: CONTACT

Phone: 932275400

Email: marius@clinic.cat

References

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.

Reference Type: DERIVED

PMID: 35058048 (View on PubMed)

Other Identifiers

TUX2020

Identifier Type: -

Identifier Source: org_study_id