Human Clinical Trial of Uterine Transplantation in the United Kingdom

The First Human Clinical Trial of Uterine Transplantation in the United Kingdom

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02388802

Enrollment

Registered

2015-03-17

Start date

2017-01-31

Completion date

2020-01-31

Last updated

2016-11-08

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

Conditions

Infertility

Keywords

Infertility, Transplant, IVF, Hysterectomy, Absolute uterine infertility

Brief summary

Ten patients will undergo uterine transplantation.

Detailed 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.

Interventions

PROCEDUREOocyte retrieval and freezing

10 Patients will undergo oocyte retrieval and freezing

PROCEDUREDeceased Donor Allograft Excision

Appropriately matched uterine transplant allografts will be excised from deceased donors

PROCEDUREUterine Transplantation

Following egg freezing the patients will undergo uterine transplant from deceased donors

DRUGImmunosuppressive Agents

Patients will be appropriately immunosuppressed, whilst being closely monitored clinically, radiologically and immunologically.

PROCEDUREIn-vitro fertilisation

12 months after successful transplantation,the patients will undergo IVF

PROCEDURECaesarean Section

Following successful conception and antenatal period, the babies will be born by Caesarean Section

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 36 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Transplant success	12 months	Efficacy as measured by successful graft transplantation with no clinical, immunological or radiological signs of graft rejection within the first 12 months post-operatively.

Secondary

Measure	Time frame	Description
Pregnancy rate	24 months	Efficacy as measured by the number of patients successful of conception by IVF
Live birth rate	36 months	Efficacy as measured by the number of live births following successful conception

Contacts

Primary ContactBenjamin P Jones, MBChB BSc

benjamin.jones@nhs.net+447740358900

Backup ContactSrdjan Saso, MRCS PhD BSc

srdjan.saso01@imperial.ac.uk+447890795182

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026