Human Clinical Trial of Uterine Transplantation in the United Kingdom

Womb Transplant UK

Status: Unknown

Conditions: Infertility

Treatments: Procedure: Deceased Donor Allograft Excision; Drug: Immunosuppressive Agents; Procedure: Oocyte retrieval and freezing; Procedure: Uterine Transplantation; Procedure: In-vitro fertilisation; Procedure: Caesarean Section

Study type: Interventional

Funder types: Other

Identifiers

NCT02388802

1

Details and patient eligibility

About

Ten patients will undergo uterine transplantation.

Full description

Ten patients that will be appropriately selected using a variety of physical and psychological assessments. The selected patients will undergo egg retrieval and subsequent freezing of embryos to enable IVF treatment following transplantation. Following uterine transplantation, using deceased donor allografts, the patients will be closely monitored for 12 months clinically, radiologically and immunologically until embryo transfer. Following successful embryo transfer the patients will continue to be monitored antenatally until they are delivered by Caesarean section.

Enrollment: 10 estimated patients

Sex: Female

Ages: 18 to 36 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female
• Between 18-36 years of age
• Absolute Uterine factor infertility

Exclusion criteria

• Poor ovarian reserve - Unsuccessful oocyte retrieval
• No intercurrent significant medical or psychiatric co-morbidities
• Previous oncology patients <5 years in remission
• Outside of age range
• Normal BMI

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Uterine transplant

Experimental group

Description:

10 patients will be appropriately selected to undergo oocyte retrieval and freezing. Subsequently deceased donor allograft excision will take place prior to uterine transplantation. Immunosuppressive agents will be used to optimise graft success until successful In-vitro fertilisation and subsequent delivery by Caesarean Section

Treatment:

Procedure: In-vitro fertilisation

Procedure: Uterine Transplantation

Drug: Immunosuppressive Agents

Procedure: Deceased Donor Allograft Excision

Procedure: Oocyte retrieval and freezing

Procedure: Caesarean Section