Autologous Ovarian Tissue Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Achievement of successful pregnancy, measured by live birth
研究概览
简要总结
Chemotherapy and radiation for cancer and other conditions can cause infertility. Several centers around the world are cryopreserving ovarian tissue from these patients though an experimental protocol, including the Fertility Preservation Program in Pittsburgh (protocol PRO08050491). The objective of this study is to study the efficacy and safety of autologous tissue transplantation in patients diagnosed with primary ovarian insufficiency after chemotherapy and/or radiation treatments.
详细描述
This investigation involves patient enrollment, thaw and surgical transplantation of previously collected cryopreserved ovarian cortical tissue, a series of follow-up assessments during the first 2 years after transplantation and an annual survey after year 2.
Screening visit (standard fertility consultation):
- The subject will complete a medical and reproductive history to document menstrual function and suitability for pregnancy.
- The subject will have standard fertility testing (including but not limited to serum Follicle Stimulating Hormone (FSH), Estradiol (E2), and Anti-Mullerian Hormone (AMH), luteinizing hormone (LH), testosterone and progesterone).
- Vaginal ultrasound will be performed for measures of ovarian volume and antral follicle counts.
- A pregnancy test will be performed to rule out pregnancy.
- Each potential subject will undergo a comprehensive fertility consult including counseling regarding the extent to which participation in this study might be of ultimate benefit. Alternatives to participation include: continuing to try to conceive on her own, use of donor oocytes or embryos, or adoption.
- The subject will have to obtain clearance from her oncologist and will be counseled by a reproductive endocrinologist to determine whether she is healthy enough to consider pregnancy and to discuss the potential risks and benefits of the study.
Visit #1 - pre-op visit (can be combined with initial screening visit):
Eligible subjects will be consented by the study physician and complete the same infectious disease testing as was performed at the time of ovarian tissue freezing (including but not limited to HIV 1&2, HTLV 1&2, Hepatitis B, Hepatitis C, syphilis, chlamydia, gonorrhea, CMV, West Nile virus). The subjects will also complete Fertility quality of life survey (FertiQoL). FertiQoL is a validated measure of quality of life in people experiencing fertility problems.
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
- •Previously cryopreserved ovarian tissue
- •Ovarian insufficiency and/or candidate for pregnancy
- •Good health
- •Oncologist's clearance
排除标准
- •Patients considered to be high risk for surgical complications
- •Women with contraindication for pregnancy if goal is to achieve pregnancy
- •Women positive for the BRCA mutations
- •Women with a history of leukemia, ovarian cancer or a cancer that likely involved ovaries at the time of ovarian tissue collection
- •Women with psychological, psychiatric, or other conditions which prevent giving fully informed consent
- •Current pregnancy
研究组 & 干预措施
Ovarian tissue transplant
Transplantation of ovarian tissue into the abdomen. Only for patients who have previously frozen ovarian tissue
干预措施: Ovarian tissue transplant (Procedure)
结局指标
主要结局
Achievement of successful pregnancy, measured by live birth
时间窗: Through study completion, up to 15 years
Indicates recovery of ovarian function
Change in reproductive hormone levels after ovarian tissue transplant
时间窗: 1,3,6,9,12 and 24 months post-transplantation
Measure of reproductive hormone levels (FSH, AMH, LH E2 and others) to detect graft function
Return of regular monthly menstrual cycles
时间窗: Through study completion, up to 15 years
Onset of regular monthly menstrual cycles after transplantation would indicate graft function. This needs to be analyzed at multiple time points to assess if regular monthly menstrual cycles have ceased, which could indicate graft failure.
次要结局
- Cancer recurrence as determined by patient's oncologist(Through study completion, up to 15 years)
- Fertility quality of life (FertiQoL) survey results(1,3,6,9,12 and 24 months post-transplantation)
- Surgical complications of ovarian tissue transplantation(1,3,6,9,12 and 24 months post-transplantation)
研究者
Kyle Orwig
Professor
University of Pittsburgh