ACTRN12622000917730招募中未知
terus transplantation as a treatment option for women with absolute uterine factor infertility
Dr Rebecca Deans0 个研究点目标入组 12 人开始时间: 2022年6月27日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 19 Years 至 60 Years（—）
- 性别
- All
入选标准
- •For recipient:
- •1.Diagnosed with AUFI and intact ovaries.
- •2.Childbearing age 18-42 years (must have embryos cryopreserved at <38 years of age).
- •3.A vaginal canal, measuring a minimum length of 7 cm, she can have vaginal dilator therapy during screening.
- •4.Non-smoker or abstinent for 6 months minimum
- •5.Body mass index less than or equal to 30
- •6.Willing to undergo in-vitro fertilization and medically cleared for in-vitro fertilization.
- •7.Women who wish to have a live donor transplant will be required to have a potential live donor.
- •8.Negative for the following sexually transmissible infections: Gonorrhoea, Chlamydia and Syphilis.
- •9.No active candida infection of the vagina.
- •10.History of Herpes (HSV-2) with no current symptoms. Subject may require preventative maintenance per study doctor discretion (anti-viral treatment).
- •11.Have 2 kidneys and a normal creatinine/eGFR level for their age
- •For living uterus (womb) donors
- •1.Blood type matching to the recipient permitting the donation
- •2.If aged < 55 years (or up to 60 years) the donor must be on hormone replacement therapy since menopause
- •3.You must not have had any previous cancers/malignancies
- •4.You must not be in poor health (i.e. you must not have diabetes, autoimmune diseases, cardiovascular disease, etc.)
- •5.You must have had no disease with an increased risk of thromboembolism (blood clots
- •6.Psychologically stable and must be prepared to undergo psychological testing
- •7.If the donor has a partner, he / she must be willing to participate in psychological testing
- •8.Non-smoker or abstinent for at least 5 years
- •For deceased uterus (womb) donors
- •2.Aged < 55 years (or up to 60 years if on HRT if known)
- •3.Suitable as brain-dead multi-organ donor, and registered as multi-organ donor as per NSW Organ and Tissue Donation Service (OTDS)
- •4.Acceptance for donation of uterus from family or previously by donor
- •5.At least one normal pregnancy and childbirth
- •6.No systemic disease
- •7.No previous major surgery in the abdomen or on uterus
- •8.No previous hysterectomy
- •9.Non-smoker if known
- •10.BMI <35
- •11.No previous malignancy of the uterus or other organ or tissue
排除标准
- •For recipient:
- •1.Subject with Diabetes Mellitus Type I and II
- •2.Subject has known hypersensitivity to drugs including: Tacrolimus, Thymoglobulin or CellCept.
- •3.Subject with existing hypertension, as per investigator’s discretion.
- •4.Subject who has a history of a bone marrow transplant.
- •5.Subject who has history of cancer in last five years.
- •6.Subject who has alcohol or drug abuse within 12 months of screening.
- •7.Subject with any pre-existing medical or psychological condition that would pose the subject at an increased risk, as per the investigator’s discretion.
- •8.Renal failure (abnormal creatinine / GFR)
- •9.Disease with an increased risk or personal history of thromboembolism
- •For living uterus (womb) donors
- •1.History of cancers in the past 5 years
- •2.Subject who has a history of a bone marrow transplant.
- •3.Systemic diseases (diabetes, autoimmune diseases, cardiovascular disease, etc.)
- •4.Disease with an increased risk or personal history of thromboembolism
- •5.Previous surgery for uterus or cervix cell changes
- •6.Positive HPV (16 or 18) or any cellular dysplasia of the cervix in the past 2 years
- •7.No previous major abdominal or uterine surgery
- •8.BMI >30
- •9.Cigarette smoker
- •10.Inability to consent to the risks of major morbidity and mortality
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