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Completed

NCT Number: NCT02987023

Uterus Transplantation From Live Donors With Robotic Assisted Surgery - Gothenburg II

The study is a follow up of NCT01844362. Uterus transplantation will be performed from live donors to patients with uterine factor infertility. If will be performed before transplantation. Organ procurement from the donor will be performed by robotic assisted laparoscopy. Transplantation will be by laparotomy. Embryo transfer will be done 10-12 months after transplantation. After birth of 1-3 children the uterus will be removed by hysterectomy,

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Key information

Conditions

Infertility, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Urogenital Diseases

Age range

20 year–38 year

Sex eligibility

Female

Study type

Observational

Primary location

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

About this study

The study is a follow up of NCT01844362. Uterus transplantation will be performed from live donors to patients with uterine factor infertility. If will be performed before transplantation. Organ procurement from the donor will be performed by robotic assisted laparoscopy. Transplantation will be by laparotomy. Embryo transfer will be done 10-12 months after transplantation. After birth of 1-3 children the uterus will be removed by hysterectomy.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age below 38 years
  • absolute uterine factor infertility
  • BMI<30

Exclusion criteria

  • systemic disease
  • psychiatric disease

Treatment and study plan

Uterus transplantation

Procedure

Uterus transplantation from live donor

Primary outcomes

  1. Live births after uterus transplantation

    Time frame: 5 years

    Assessed by records from birthing unit and Swedish National Birth registry

Secondary outcomes

  1. Development of children after uterus transplantation

    Time frame: 8 years

    Assessed by growth parameters and neuropsychiatric tests (Bayley Mental Scale, M-CHAT, CBCL, WPPSI-IV)

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Acronym: UTX-robot

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Dec 8, 2016
Registry last updated
Jun 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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