INvestigational Study Into Transplantation of the Uterus

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04244409

Acronym

INSITU

Enrollment

Registered

2020-01-28

Start date

2019-02-18

Completion date

2024-02-18

Last updated

2020-01-28

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

Conditions

Asherson's Syndrome, Cervical Cancer, Mayer-Rokitansky-Kuster Syndrome, Postpartum Hemorrhage

Keywords

Gynaecology, Immunosuppression, In-vitro Fertilisation, Infertility, MRKH, Pregnancy, Transplantation, Uterus

Brief summary

Observational study on cohort of 10 women undergoing uterine transplantation using deceased donors

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

24 Years to 38 Years

Inclusion criteria

1. Female 2. Age - 24-38 (or 40 if eggs frozen \<38) 3. AUFI 1. Normal length vagina 2. No renal pathology 4. BMI \<30kg/m2 5. ASA grade I 6. Meet psychological criteria 7. Meet HFEA criteria for IVF 8. Eligible for NHS treatment 9. Speak fluent English

Exclusion criteria

1. Unsuccessful oocyte retrieval (\<10 good quality embryos) 2. Previous multiple/significant surgeries 3. Severe endometriosis 4. Cancer patients \<5 years in remission 5. Previous living childbirth, adopted child or child born through surrogacy 6. HIV or Hepatitis B / C positive 7. Skin or intestinal neovagina

Design outcomes

Primary

Measure	Time frame
Live birth rate	5 years

Secondary

Measure	Time frame
Pregnancy rate	5 years
Transplant success rate	3 years

Countries

United Kingdom

Outcome results