Human Clinical Trial of Uterine Transplantation in the United Kingdom
NCT ID: NCT02388802
Last Updated: 2016-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2017-01-31
2020-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Uterine transplant
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
Oocyte retrieval and freezing
10 Patients will undergo oocyte retrieval and freezing
Deceased Donor Allograft Excision
Appropriately matched uterine transplant allografts will be excised from deceased donors
Uterine Transplantation
Following egg freezing the patients will undergo uterine transplant from deceased donors
Immunosuppressive Agents
Patients will be appropriately immunosuppressed, whilst being closely monitored clinically, radiologically and immunologically.
In-vitro fertilisation
12 months after successful transplantation,the patients will undergo IVF
Caesarean Section
Following successful conception and antenatal period, the babies will be born by Caesarean Section
Interventions
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Oocyte retrieval and freezing
10 Patients will undergo oocyte retrieval and freezing
Deceased Donor Allograft Excision
Appropriately matched uterine transplant allografts will be excised from deceased donors
Uterine Transplantation
Following egg freezing the patients will undergo uterine transplant from deceased donors
Immunosuppressive Agents
Patients will be appropriately immunosuppressed, whilst being closely monitored clinically, radiologically and immunologically.
In-vitro fertilisation
12 months after successful transplantation,the patients will undergo IVF
Caesarean Section
Following successful conception and antenatal period, the babies will be born by Caesarean Section
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Between 18-36 years of age
* Absolute Uterine factor infertility
Exclusion Criteria
* No intercurrent significant medical or psychiatric co-morbidities
* Previous oncology patients \<5 years in remission
* Outside of age range
* Normal BMI
18 Years
36 Years
FEMALE
No
Sponsors
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Imperial College London
OTHER
Womb Transplant UK
OTHER
Responsible Party
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Principal Investigators
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Richard Smith, FRCOG, MD
Role: PRINCIPAL_INVESTIGATOR
Imperial NHS Healthcare Trust
Central Contacts
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References
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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.
Other Identifiers
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1
Identifier Type: -
Identifier Source: org_study_id