Female Infertility
Conditions
Keywords
Infertility, AUFI
Brief summary
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.
Detailed description
There are approximately 9.5 million women in the United States with Absolute Uterine Factor Infertility (AUFI).Congenital uterine infertility in women is linked to a malformed or absent mullerian system termed MRKH - Rokitansky's or Mayer-Rokitansky-Kuster-Hauser Syndrome). Additional causes of acquired uterine infertility include a hysterectomy subsequent to life-threatening hemorrhage during childbirth or as a consequence to a hysterectomy related to cervical cancer or for large symptomatic fibroids. Additional causes may include intrauterine adhesions subsequent to surgical abortion or infection. Uterine transplantation will provide a much needed medical option for many women in the U.S. and overseas who are unable to carry their own children based on uterine infertility. Centers outside of the US have initiated uterus transplant programs. Initial attempts were reported from Saudi Arabia. While the deceased donor transplant had been successful, successful pregnancies were not achieved. Another deceased donor transplant had been performed in Turkey with a uterus procured from a deceased donor. Although several IVF attempts had been performed, they had not resulted in live births. Uterus transplants from live donors have been successful. In October 2014, Swedish doctors treating a woman born without a uterus, announced the world's first live birth of a healthy baby boy after a live donor uterine transplantation. Since then, an additional three babies have been born in Sweden to mothers who received live donor uterus transplants. A fifth baby is at term and a 6th pregnancy has been reported. For this study, the investigators plan to screen 30 patients in order to enroll 10 patients, 5 recipients and their respective donors. Prospective recipients will undergo comprehensive medical and psychological evaluation. If deemed an appropriate candidate, In Vitro Fertilization would be started with the goal of obtaining 6 normal embryos for implantation. The uterus of a suitable live donor would then transplanted into the recipient. The recipient would need to take potent anti-rejection drugs and undergo regular assessments for rejection. After one year, embryo transfer to the transplanted uterus would be tried. Up to 6 cycles would be attempted hopefully resulting in pregnancy. If pregnancy results, the recipient would be followed by the high risk pregnancy team. Delivery will be by Caesarian Section. A woman may have up to 2 pregnancies with the transplanted uterus. The uterus is later removed so the recipient no longer has to take anti-rejection drugs.
Interventions
Treating 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.
Sponsors
Study design
Eligibility
Inclusion criteria
Uterine Transplant Inclusion/
Exclusion criteria
RECIPIENT:Inclusion Criteria * 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. * Normal kidney function * Able to undergo transplant and be compliant with treatment * Has stable partner and social supports * Partner willing to undergo psychological evaluation and receive immunizations as recommended * Stable home environment to support a child
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of successful live births following uterus transplant/embryo transfer | 2 years after uterine transplant | Full term live birth by caesarian section after uterus transplant and IVF |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of complications during pregnancy in uterus transplant recipient | 9 months after pregnancy achieved by embryo transfer | 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 |
| Rate of complications following uterine donation | Up to 2 years post donation | Monitoring for excessive bleeding, infection and bladder dysfunction. Also monitoring blood clots in the legs. |
| Impact of uterine donation on donor quality of life | Up to 2 years post donation | 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. |
| Cost comparison for uterine transplant vs. surrogacy vs adoption | Up to 5 years after uterine transplant | 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 |
| Impact of uterine transplant on quality of life | Up to 5 years after uterine transplant | Measured by serial SF 36 QOL survey by psychiatrist pre-transplant and at follow-up appointments.. |
Countries
United States
Contacts
Brigham and Womens Hospital