Human Clinical Trial of Uterine Transplantation in the United Kingdom

Study Overview
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Brief Summary
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Ten patients will undergo uterine transplantation.

Detailed Description
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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.

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

Conditions
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Infertility

Intervention / Treatment
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* Procedure: Oocyte retrieval and freezing
* Procedure: Deceased Donor Allograft Excision
* Procedure: Uterine Transplantation
* Drug: Immunosuppressive Agents
* Procedure: In-vitro fertilisation
* Procedure: Caesarean Section


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 36 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Uterine transplant<br>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 | Procedure: Oocyte retrieval and freezing<br>* 10 Patients will undergo oocyte retrieval and freezing<br>Procedure: Deceased Donor Allograft Excision<br>* Appropriately matched uterine transplant allografts will be excised from deceased donors<br>* Other names: Cadaveric Donor Allograft Excision;Procedure: Uterine Transplantation<br>* Following egg freezing the patients will undergo uterine transplant from deceased donors<br>* Other names: Womb Transplant;Drug: Immunosuppressive Agents<br>* Patients will be appropriately immunosuppressed, whilst being closely monitored clinically, radiologically and immunologically.<br>* Other names: Immunosuppressives;Procedure: In-vitro fertilisation<br>* 12 months after successful transplantation,the patients will undergo IVF<br>* Other names: IVF;Procedure: Caesarean Section<br>* Following successful conception and antenatal period, the babies will be born by Caesarean Section<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infertility, Transplant, IVF, Hysterectomy, Absolute uterine infertility