A Novel Ovarian Reserve Monitoring Algorithm for Patients at Risk of Ovarian Injury From Gonadotoxic Therapy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 26,704
- 主要终点
- Does the novel monitoring algorithm (intervention group) detect early Ovarian disfunction
研究概览
简要总结
This is an observational cohort study to examine the use of a novel proposed ovarian reserve monitoring algorithm to (1) identify patients who are at risk of DOR and POI from gonadotoxic therapy, (2) minimize time from treatment to utilization of assisted reproductive technologies, and (3) improves prognosis for successful ART based on AFC for patients who pursue fertility or fertility preservation.
详细描述
Study Design: This is an observational cohort study to examine the use of a novel proposed ovarian reserve monitoring algorithm to (1) identify patients who are at risk of DOR and POI from gonadotoxic therapy, (2) minimize time from treatment to utilization of assisted reproductive technologies, and (3) improves prognosis for successful ART based on AFC for patients who pursue fertility or fertility preservation.
Group B: Prospectively, survivors will be evaluated by a member of the FPRLE team in the outpatient clinic at 12 months post-therapy completion and every 6 months to 36 months as part of clinical care. AMH and FSH will be drawn at each time point.
Group A: Retrospectively, we will abstract AMH and FSH from survivors seen at CHCO and UCH from October 1st, 2016 to September 31st, 2019 and assess time points.
Approach Aim 1: The Investigator will assess AMH and FSH in both groups and evaluate whether the monitoring algorithm allows for early identification of DOR prior to the occurrence of POI. The investigator will calculate time from end of treatment to diagnosis of DOR and POI to evaluate if the monitoring algorithm detects these conditions earlier than historical controls.
Statistical analysis: The investigator will provide descriptive statistics and time to event analysis by group.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 8 Years 至 39 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •· Female patients ages 8 - 39 years of age
- •Seen in CHCO or AMC outpatient clinics for any of the following reasons:
- •At risk for fertility problems (Z91.89)
- •Encounter for fertility preservation counseling (Z31.62)
- •Primary ovarian insufficiency
- •Premature ovarian failure/premature menopause
- •Diminished ovarian reserve
- •At least 12 months post-completion of chemotherapy and/or radiation
- •History of a fertility-threatening diagnosis receiving chemotherapy; radiation; or surgery to the reproductive organs for malignancy, including but not limited to:
- •Any type of cancer/malignancy
- •Rheumatoid arthritis
- •Systemic lupus erythematosus
- •Aplastic anemia
- •Fanconi anemia
- •Diamond-Blackfan syndrome
- •Hurler syndrome
- •Other autoimmune conditions
排除标准
- •Disorders of sexual development (i.e., gonadal dysgenesis, Turner syndrome/mosaicism, etc.)
- •History of bilateral oophorectomy
- •Transgender patients not receiving chemotherapy; radiation; or surgery to the reproductive organs for malignancy
- •Inability to consent/assent
结局指标
主要结局
Does the novel monitoring algorithm (intervention group) detect early Ovarian disfunction
时间窗: 2 year follow up
We will compare ovarian reserve categories (normal, diminished ovarian reserve, primary ovarian insufficiency), defined using AMH and FSH, in a retrospective group using the standard of care and a prospective group using a new monitoring algorithm.
次要结局
- Time to ART(2 year follow up)
- Evaluate if there is an improved AFC in the new monitoring algorithm group(2 year follow up)
- Characterizing barriers to utilization of ART(2 year year follow up)