Uterine Transplantation and Pregnancy Induction in Women Affected by Absolute Uterine Factor Infertility
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Number of successful live births after uterine transplant and IVF.
研究概览
简要总结
This study aims to investigate the treatment of absolute uterine infertility (AUI) due to congenital or surgical absence of a uterus or presence of a nonfunctioning uterus. The investigators will follow a model based on a Swedish study to enroll 20 women with functioning ovaries and successfully transplant the uterus from either a living or cadaveric donor, with the goal of live birth after transplantation.
详细描述
INTRODUCTION
Absolute Uterine Factor Infertility (AUI) is due to congenital or surgical absence of a uterus or presence of a nonfunctional uterus. Until 2014 the only option for women affected by Absolute Uterine Factor Infertility (AUI) was adoption or surrogate motherhood.
Primary Objective
- Successful living or deceased donor uterine transplants resulting in live birth.
- Pregnancy rate via in vitro fertilization.
BACKGROUND
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
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women diagnosed with Absolute Uterine Infertility (AUI) and intact native ovaries.
- •Women of childbearing age 20-
- •Human papillomarvius negative or received vaccination for human papillomarvius virus (HPV). Subjects with a history of HPV in the past must show a negative history since and test negative at screening.
- •A subject who is negative for Gonorrhea, Chlamydia and Syphilis.
- •A subject with the history of Herpes (HSV-2) with no current symptoms. Subject may require preventative maintenance per study doctor discretion.
- •Subjects have received counseling regarding infertility alternatives to uterine transplant such as adoption or surrogate pregnancy.
- •Willing to undergo in-vitro fertilization and medically cleared for in-vitro fertilization.
- •Evaluated by a fertility specialist and determined to have good ovarian reproductive potential and ability to carry fetus to term.
- •Must have the ability to fund, either through third party coverage or through other their own personal financing, any expenses associated with assisted reproduction services provided to them.
- •Meets physiological recipient criteria
排除标准
- •Subject with Diabetes Mellitus Type I and II by medical history or elevated hemoglobin A1c blood test.
- •Subject has known hypersensitivity to Tacrolimus, Thymoglobulin or CellCept.
- •Subject with existing hypertension, per investigator's discretion.
- •Subject who has a history of solid organ or bone marrow transplant.
- •Subject who has history of cancer in last five years.
- •Subject with a body mass index >
- •Subject with an active infection.
- •Subject who is seropositive for HIV, HBV, HCV
- •Subject with technical obstacles as per anatomical malformations, which pose a high surgical risk in the judgment of the investigator.
- •Subject unwilling or unable to comply with study requirements.
- •Subject unable to undergo in-vitro fertilization or not cleared for transplant.
- •Subject who has smoked within the last 12 months.
- •Subject who has alcohol or drug abuse within 12 months of screening.
- •Subject with any pre-existing clinical or medical conditions that would pose the subject at an increased risk, as per the investigator's discretion.
研究组 & 干预措施
Uterine Transplant
Women will undergo uterine transplantation after IVF. Donor uterus will be from either a living donor or cadaveric.
干预措施: Uterine Transplant (Procedure)
结局指标
主要结局
Number of successful live births after uterine transplant and IVF.
时间窗: 2 years after transplant
Full term birth by cesarean section.
次要结局
未报告次要终点