Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Imperial College London | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Ten patients will undergo uterine transplantation.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Uterine transplant | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oocyte retrieval and freezing | Procedure | 10 Patients will undergo oocyte retrieval and freezing |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Benjamin P Jones, MBChB BSc | Contact | +447740358900 | benjamin.jones@nhs.net | |
| Srdjan Saso, MRCS PhD BSc | Contact | +447890795182 | srdjan.saso01@imperial.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Richard Smith, FRCOG, MD | Imperial NHS Healthcare Trust | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38070921 | Derived | Jones BP, Vali S, Kasaven LS, Mantrali I, Saso S, Bracewell-Milnes T, Nicopoullos J, Thum MY, Diaz-Garcia C, Quiroga I, Yazbek J, Smith JR. INvestigational Study Into Transplantation of the Uterus (INSITU): a cross-sectional survey among women with uterine factor infertility in the UK assessing background, motivations and suitability. BMJ Open. 2023 Dec 9;13(12):e073517. doi: 10.1136/bmjopen-2023-073517. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D054315 | Oocyte Retrieval |
| D005615 | Freezing |
| D007166 | Immunosuppressive Agents |
| D005307 | Fertilization in Vitro |
| D002585 | Cesarean Section |
| ID | Term |
|---|---|
| D027724 | Reproductive Techniques, Assisted |
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
| D020858 | Tissue and Organ Harvesting |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Deceased Donor Allograft Excision | Procedure | Appropriately matched uterine transplant allografts will be excised from deceased donors |
|
|
| Uterine Transplantation | Procedure | Following egg freezing the patients will undergo uterine transplant from deceased donors |
|
|
| Immunosuppressive Agents | Drug | Patients will be appropriately immunosuppressed, whilst being closely monitored clinically, radiologically and immunologically. |
|
|
| In-vitro fertilisation | Procedure | 12 months after successful transplantation,the patients will undergo IVF |
|
|
| Caesarean Section | Procedure | Following successful conception and antenatal period, the babies will be born by Caesarean Section |
|
| 36 months |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D044367 | Phase Transition |
| D055585 | Physical Phenomena |
| D003080 | Cold Temperature |
| D013696 | Temperature |
| D013816 | Thermodynamics |
| D055598 | Chemical Phenomena |
| D007155 | Immunologic Factors |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |