Uterus Transplantation From Live Donor

Primary Uterine Infertility Clinical Trial

— utx  

Official title:

Prospective Case Series of Human Uterus Transplantation From Live Donor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01844362
• Other study ID #: utx-ld
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: December 1, 2021

Study information

• Verified date: December 2021
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Uterus transplantation, as a possible future treatment for uterine factor infertility, has been developed in animal species during the last decade.

The study protocol includes transplantation of the uterus from a live donor (mother, relative, friend) into women with absolute uterine factor infertility (lack of uterus from birth or due to life saving hysterectomy).The recipient will be treated by standard immunosuppression and transfer of embryos (acquired by IVF before surgery) will be attempted when at least 12 months have passed from transplantation. Approval for a case series including up to 10 patients has been acquired.

Description:

The study is ongoing, with inclusion of 9 patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 1, 2021
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• less than 39 years

• good general health

Exclusion Criteria:

• poor ovarian resaerve or older than 39 years

• systemic or psychiatric disease

Related Conditions & MeSH terms

• Infertility
• Primary Uterine Infertility

Intervention

Procedure:
• uterine transplantation
Transplantation of the uterus from live donor and IVF treatment.

Locations

Country	Name	City	State
Sweden	Mats Brännström	Göteborg

Sponsors (2)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden	The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

References & Publications (6)

Brännström M, Bokström H, Dahm-Kähler P, Diaz-Garcia C, Ekberg J, Enskog A, Hagberg H, Johannesson L, Kvarnström N, Mölne J, Olausson M, Olofsson JI, Rodriguez-Wallberg K. One uterus bridging three generations: first live birth after mother-to-daughter ut — View Citation

Brännström M, Johannesson L, Bokström H, Kvarnström N, Mölne J, Dahm-Kähler P, Enskog A, Milenkovic M, Ekberg J, Diaz-Garcia C, Gäbel M, Hanafy A, Hagberg H, Olausson M, Nilsson L. Livebirth after uterus transplantation. Lancet. 2015 Feb 14;385(9968):607- — View Citation

Brännström M, Johannesson L, Dahm-Kähler P, Enskog A, Mölne J, Kvarnström N, Diaz-Garcia C, Hanafy A, Lundmark C, Marcickiewicz J, Gäbel M, Groth K, Akouri R, Eklind S, Holgersson J, Tzakis A, Olausson M. First clinical uterus transplantation trial: a six — View Citation

Järvholm S, Johannesson L, Brännström M. Psychological aspects in pre-transplantation assessments of patients prior to entering the first uterus transplantation trial. Acta Obstet Gynecol Scand. 2015 Oct;94(10):1035-8. doi: 10.1111/aogs.12696. Epub 2015 J — View Citation

Järvholm S, Johannesson L, Clarke A, Brännström M. Uterus transplantation trial: Psychological evaluation of recipients and partners during the post-transplantation year. Fertil Steril. 2015 Oct;104(4):1010-1015. doi: 10.1016/j.fertnstert.2015.06.038. Epu — View Citation

Johannesson L, Kvarnström N, Mölne J, Dahm-Kähler P, Enskog A, Diaz-Garcia C, Olausson M, Brännström M. Uterus transplantation trial: 1-year outcome. Fertil Steril. 2015 Jan;103(1):199-204. doi: 10.1016/j.fertnstert.2014.09.024. Epub 2014 Oct 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	live birth rate		up to 4 years after transplantation
Primary	surviving transplants (12 months)		up to 3 years after transplantation
Secondary	pregnancy rate		up to 3 years after transplantation