NCT02388802

Brief Summary

Ten patients will undergo uterine transplantation.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
1.8 years until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

November 8, 2016

Status Verified

November 1, 2016

Enrollment Period

3 years

First QC Date

February 12, 2015

Last Update Submit

November 7, 2016

Conditions

Infertility

Keywords

InfertilityTransplantIVFHysterectomyAbsolute uterine infertility

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Pregnancy rate

    24 months

  • Live birth rate

    36 months

Study Arms (1)

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

Procedure: Oocyte retrieval and freezingProcedure: Deceased Donor Allograft ExcisionProcedure: Uterine TransplantationDrug: Immunosuppressive AgentsProcedure: In-vitro fertilisationProcedure: Caesarean Section

Interventions

Oocyte retrieval and freezingPROCEDURE

10 Patients will undergo oocyte retrieval and freezing

Uterine transplant
Deceased Donor Allograft ExcisionPROCEDURE

Appropriately matched uterine transplant allografts will be excised from deceased donors

Also known as: Cadaveric Donor Allograft Excision
Uterine transplant
Uterine TransplantationPROCEDURE

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

Also known as: Womb Transplant
Uterine transplant
Immunosuppressive AgentsDRUG

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

Also known as: Immunosuppressives
Uterine transplant
In-vitro fertilisationPROCEDURE

12 months after successful transplantation,the patients will undergo IVF

Also known as: IVF
Uterine transplant
Caesarean SectionPROCEDURE

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

Uterine transplant

Eligibility Criteria

Age18 Years - 36 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 38070921DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Oocyte RetrievalFreezingImmunosuppressive AgentsFertilization in VitroCesarean Section

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques, AssistedReproductive TechniquesTherapeuticsTissue and Organ HarvestingTransplantationSurgical Procedures, OperativeInvestigative TechniquesPhase TransitionPhysical PhenomenaCold TemperatureTemperatureThermodynamicsChemical PhenomenaImmunologic FactorsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesDelivery, ObstetricObstetric Surgical Procedures

Study Officials

  • Richard Smith, FRCOG, MD

    Imperial NHS Healthcare Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin P Jones, MBChB BSc

CONTACT

+447740358900benjamin.jones@nhs.net

Srdjan Saso, MRCS PhD BSc

CONTACT

+447890795182srdjan.saso01@imperial.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2015

First Posted

March 17, 2015

Study Start

January 1, 2017

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

November 8, 2016

Record last verified: 2016-11