Uterine Transplant in Absolute Uterine Infertility (AUIF)
ConditionFemale Infertility
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorBrigham and Women's Hospital
About this trial
This study will examine the feasibility of initiating a uterine transplant program for Absolute Uterine Factor Infertility (AUFI) at Brigham and Women's Hospital. The investigators plan to screen 30 patients with a goal of enrolling 10 patients. (5 donors and 5 recipients) After careful screening, appropriate candidates will undergo IVF, Uterine Transplantation, Embryo Transfer, Pregnancy and Delivery. Once the uterus is explanted, five years of follow-up is planned.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Age 18-40
Clinical evidence of AUFI (Absolute Uterine Factor Infertility)
Able to produce at least 6 normal embryos by IVF for future use
Reasonable weight with BMI (Body Mass Index) less than 30.
Trial design
Design model
Single group
Treatments tested in this trial
Uterine Transplant
Procedure/SurgeryTreating Absolute Uterine Factor Infertility by Uterus Transplant. Potential recipients undergo IVF to obtain 6 embryos for cryopreservation followed by live donor uterine transplant. After 1 year, embryo transfer is done to achieve pregnancy. Delivery is by Caesarian section. The recipient may have up to 2 children by these methods and then the uterus is removed so that immunosuppression can be stopped.
Treatment groups
3 Participants
are divided into 1 treatment groupGroup A: Women with AUFIExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of successful live births following uterus transplant/embryo transfer
Full term live birth by caesarian section after uterus transplant and IVF
Time frame
2 years after uterine transplantSecondary outcomes
1
Rate of complications during pregnancy in uterus transplant recipient
Close monitoring for pre-eclampsia, hypertension, diabetes, and pre-term delivery. Monitoring for signs of rejection, should it occur, you would first be treated with steroids
Time frame
9 months after pregnancy achieved by embryo transfer2
Rate of complications following uterine donation
Monitoring for excessive bleeding, infection and bladder dysfunction. Also monitoring blood clots in the legs.
Time frame
Up to 2 years post donation3
Impact of uterine donation on donor quality of life
Measured by serial SF 36 QOL survey by psychiatrist at pre-donation and at follow-up appointments. The SF-36 evaluates general health perception, perceived change in health over time, physical functioning, role limitations due to physical or emotional health, and activity limitations. Emotional well-being will also be assessed using the Hospital Anxiety and Depression Scale (HADS), a validated questionnaire scored from 0 to 3 per item.
Time frame
Up to 2 years post donation4
Cost comparison for uterine transplant vs. surrogacy vs adoption
At the end of the study, investigators will calculate average cost of each modality, i.e. transplant vs surrogacy vs adoption to compare the three alternatives to infertility
Time frame
Up to 5 years after uterine transplantSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov