Clinical trial NCT02987023: Uterus Transplantation From Live Donors With Robotic Assisted Surgery - Gothenburg II
Official title: Uterus Transplantation From Live Donors With Robotic Assisted Surgery - Gothenburg II
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility, Female
Keywords: infertility, uterus, transplantation
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2016-12-08
Enrollment: 8
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: absolute uterine factor infertile women \> 38 years

Brief summary: 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,

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* age below 38 years
* absolute uterine factor infertility
* BMI\<30

Exclusion Criteria:

* systemic disease
* psychiatric disease

Primary outcomes:
measure: Live births after uterus transplantation
timeFrame: 5 years
Secondary outcomes:
measure: Development of children after uterus transplantation
timeFrame: 8 years
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Göteborg University
name: Mats Brännström, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dahm-Kahler P, Kvarnstrom N, Brannstrom M. Robotic live donor hysterectomy. Curr Opin Organ Transplant. 2021 Dec 1;26(6):640-645. doi: 10.1097/MOT.0000000000000926.
citation: Brannstrom M, Kvarnstrom N, Groth K, Akouri R, Wiman L, Enskog A, Dahm-Kahler P. Evolution of surgical steps in robotics-assisted donor surgery for uterus transplantation: results of the eight cases in the Swedish trial. Fertil Steril. 2020 Nov;114(5):1097-1107. doi: 10.1016/j.fertnstert.2020.05.027. Epub 2020 Aug 19.
citation: Brannstrom M, Dahm-Kahler P, Ekberg J, Akouri R, Groth K, Enskog A, Broecker V, Molne J, Ayoubi JM, Kvarnstrom N. Outcome of Recipient Surgery and 6-Month Follow-Up of the Swedish Live Donor Robotic Uterus Transplantation Trial. J Clin Med. 2020 Jul 22;9(8):2338. doi: 10.3390/jcm9082338.
citation: Brannstrom M, Dahm-Kahler P, Kvarnstrom N, Enskog A, Olofsson JI, Olausson M, Molne J, Akouri R, Jarvholm S, Nilsson L, Stigson L, Hagberg H, Bokstrom H. Reproductive, obstetric, and long-term health outcome after uterus transplantation: results of the first clinical trial. Fertil Steril. 2022 Sep;118(3):576-585. doi: 10.1016/j.fertnstert.2022.05.017. Epub 2022 Jun 11.