ACTRN12619000808145招募中1 期
terus Transplantation and Pregnancy Induction in Women affected by Absolute Uterine Factor Infertility
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
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
- 40 Years 至 65 Years（—）
- 性别
- Female
入选标准
- •a. The prospective donor must be between 40-65 years of age
- •b. The prospective donor must have a normal uterus on ultrasound and CT;
- •c. The prospective donor must meet psychosocial criteria;
- •d. The prospective donor must have had at least one prior live birth (gestation > 34-weeks).
- •1. Inclusion Criteria Recipient
- •a. Prospective recipient must be diagnosed with AUFI and have at least one functioning ovary;
- •b. Prospective recipient must be of childbearing age 18 – 45;
- •c. Prospective recipient must have received counselling regarding alternatives to UT such as adoption or surrogate pregnancy;
- •d. Prospective recipient must be willing to undergo in-vitro fertilization;
- •e. Prospective recipient must have been evaluated by a fertility specialist and determined to have good ovarian reproductive potential or are prepared to use donor oocytes;
- •f. Prospective recipient must meet psychosocial criteria;
- •g. Prospective recipient must be willing to complete questionnaires about their infant’s growth and development and return them to the study team.
排除标准
- •a. Prospective donor over the age of 65;
- •b. Body mass index >30;
- •c. There should be no history of significant uterine or cervical surgery;
- •d. History of cigarette smoking in the past 3-months;
- •e. Prospective donor with active human 142 papillomavirus (HPV) or active cervical dysplasia;
- •f. Prospective Donor with untreated Gonorrhoea, Chlamydia or Syphilis;
- •g. In prospective donors who are positive for HSV-2 the prospective recipient will require additional counselling; the prospective donor should receive preventative therapy in order to prevent a flare in the peri-operative phase; the prospective recipient may also require preventative therapy;
- •h. Prospective donor with an active infection;
- •i. Prospective donor who is seropositive for HIV;
- •j. In prospective donors who are seropositive for HBV or HCV the prospective recipient will require additional counselling;
- •k. Prospective donor who has had cancer in last five years;
- •l. Prospective donor with any pre-existing clinical or medical conditions that would pose the donor at an increased risk, as per the investigator’s discretion;
- •m. Prospective donor unwilling or unable to comply with study requirements.
- •2. Exclusion Criteria for recipients
- •a. Prospective recipient who has active human 142 papillomavirus (HPV);
- •b. Prospective recipient with untreated Gonorrhoea, Chlamydia or Syphilis;
- •c. In prospective recipients who are positive for HSV-2 the prospective recipient will require additional counselling; the prospective recipient may also require preventative therapy;
- •d. Prospective recipient with Diabetes Mellitus Type I or II;
- •e. Prospective recipient with a known hypersensitivity to immunosuppressive medications;
- •f. Prospective recipient with existing hypertension, per investigator’s discretion;
- •g. Prospective recipient who has a history of solid organ or bone marrow transplant, per investigator’s discretion;
- •h. Prospective recipient who has a history of cancer, per investigator’s discretion;
- •i. Prospective recipient with a body mass index >30;
- •j. Prospective recipient with an active infection;
- •k. Prospective recipient who is seropositive for HIV;
- •l. In a prospective recipient who is seropositive for HBV or HCV the prospective recipient will require additional counselling and possible treatment;
- •m. Prospective recipient with technical obstacles as per anatomical malformations, which pose a high surgical risk in the judgment of the investigator;
- •n. Prospective recipient unwilling or unable to comply with study requirements;
- •o. Prospective recipient unable to undergo in-vitro fertilization;
- •p. Prospective recipient who has smoked within the last 3 months, per investigator’s discretion;
- •q. Prospective recipient who has alcohol or drug abuse within 12 months of screening;
- •r. Prospective recipient with any pre-existing clinical or medical conditions that would pose the subject at an increased risk, as per the investigator’s discretion.
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