Uterine Transplantation for the Treatment of Uterine Factor Infertility
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Number of successful live births after uterus transplant and IVF
研究概览
简要总结
This feasibility study aims to enroll ten subjects who will undergo deceased donor uterine transplantation at Cleveland Clinic. We estimate that fifty to one hundred patients with uterine factor infertility will need to be screened to identify 10 appropriate subjects.
There are seven phases involved in this study: Primary and Secondary Screening, Medical Evaluation, IVF, Transplantation, Embryo Transfer, Pregnancy/Delivery and Follow up
详细描述
Uterine factor infertility (UFI) is one of the few irreversible causes of female infertility. Until recently, no medical or surgical options have been available for women with this diagnosis. UFI is defined by the lack of a functional uterus; this condition can either be congenital (e.g. Rokitansky syndrome, where a woman is born without an intact uterus) or acquired (e.g. resulting from hysterectomy or damage to the uterus from procedures or infections).
Uterine infertility affects 3-5% of the female population. It is estimated that there are at least 50,000 women of reproductive age with uterine infertility in the United States. Existing options for women affected by UFI are limited to adoption or maternal surrogacy. Surrogacy involves harvesting eggs from the UFI patient and fertilizing these eggs in a lab with the intention of implanting fertilized embryos into a third party who will carry the pregnancy. Adoption and surrogacy are considered acceptable options for many women with UFI. For others, due to social, ethical, cultural and/or religious reasons, these options are not permissible. In many countries around the world, maternal surrogacy is illegal, leaving no option for UFI patients to conceive a biological child.
Recently, uterine transplantation has been proposed as an alternative method of treating UFI. Uterine transplantation is intended as a life enhancing procedure, not a life saving procedure, and is considered to be similar to transplants of the face, extremities and pancreas. Interestingly, uterine transplantation is considered an "ephemeral" transplant, and is not intended to last for the duration of the life of the recipient. The transplant is maintained for only as long as is necessary to produce one or two offspring for the patient.
The need for novel approaches to UFI is clear and exciting work from a team of investigators in Sweden has finally demonstrated this year that uterine transplantation can result in the successful delivery of healthy infants with minimal risk to the mother. After careful collaboration with this Swedish group, we now aim to bring the first uterine transplantation protocol to the United States using a multidisciplinary team of investigators from within the Cleveland Clinic.
There have been 11 uterine transplants performed in humans worldwide. The first uterine transplant was performed in Saudi Arabia in 2000. The living-donor graft survived for 3 months and was subsequently removed due to graft failure. The failure of the graft was attributed to thrombosis (blood clots affecting the circulation to the organ). Pregnancy was never attempted using the transplanted uterus prior to it being removed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Must meet criteria for uterine factor infertility
- •Prior hysterectomy
- •Congenital absence or malformation of the uterus preventing pregnancy c, Infertility due to uterine damage from prior injury or infection
- •Must be between the ages of 21-45 and the embryos must have been produced between the age of 21-
- •(age at the time the embryos are produced, not current age)
- •Must be willing to undergo a psychiatric and social work pre-transplant evaluation
- •Must be willing to undergo general anesthesia, in vitro fertilization, major gynecologic surgery, pregnancy with potential high risk complications, cesarean delivery and eventual hysterectomy to remove the graft
- •Must be willing and able to receive potent immunosuppressive medications and must be able to follow standard infection prophylaxis protocols
- •Must be willing to receive standard vaccinations such as influenza, pneumococcus, human papillomavirus (HPV) and hepatitis B
- •Must be willing and able to sign informed consent and follow all outlined procedures and recommendations in the protocol
排除标准
- •History of hypertension, diabetes, or significant heart, liver, kidney or central nervous system disease
- •Any medical diagnosis placing the subject at high risk of surgical complications based on the transplant team's review of medical history.
- •Current smoker (smoking cessation must have occurred 3 months prior to enrollment)
- •History of prior malignancy except for cervical cancer in stage 1a or 1b after 3 years.
- •Human immunodeficiency virus, mycobacteria, hepatitis B (Hepatitis risk is for those with hepatitis B (HB) surface and/or core antigen and/or hepatitis B virus (HBV) DNA positive. Thos that are HB core antibody positive are at minimal risk and everyone else is not at risk), or hepatitis C.
- •Presence of active documented systemic infection or recent systemic infection within the past three months
- •Chemical and/or alcohol dependency or abuse
- •Presence of low lying pelvic kidney(s). Pelvic and horse shoe kidneys are common in the Rokitansky syndrome, and occur with a frequency as high as 30-40%. These abnormalities are usually known to subjects as part of their Mullerian agenesis diagnosis. If the patient is unsure about the status of their kidneys, the performance of a renal ultrasound is considered standard of care. These patients need to be informed of any kidney abnormalities, as they are frequently associated with kidney stones or obstructive kidney disease.
- •BMI greater than 30 kg/m2
结局指标
主要结局
Number of successful live births after uterus transplant and IVF
时间窗: 2 years after transplantation
Full term birth by cesarian section after IVF followed by uterus transplant
次要结局
未报告次要终点
研究者
Michelle Kuznicki
Staff Physician
The Cleveland Clinic