4-step ASCOT in POI Women to Promote Follicular Rescue
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- AFC
研究概览
简要总结
To promote follicular development in POI women, G-CSF mobilized activated platelet rich plasma will be directly injected into the ovarian medulla.
This is a prospective, observational, multicentric, open, pilot-controlled randomized trial which seeks to evaluate the impact of the 4-step ASCOT technique on the ovarian reserve and reproductive outcomes of POI patients. The study will be developed in two phases.
In a first step, POI women will randomized to control or undergo the 4-step ASCOT technique based on the direct ovarian injection of G-CSF mobilized and activated PRP. Follow up (AFC, AMH, FSH and E2 determinations) will be developed for 3 month in the controls and for 6 months in the treated and COS initiated if growing antral follicles detected. In the second phase, POI women allocated to control group after completed the follow up period will undergo the 4-step ASCOT technique, as described in the previous phase but only one ovary will be injected, then they will undergo a 6-month follow up period as described above.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects who meet the following will be considered eligible to participate in the clinical trial:
- •Informed consent form dated and signed.
- •Age between 18 and 38 (both inclusive)
- •Women who meet the ESHRE criteria for POI [41]
- •presence of menstrual disturbance defined as oligo/amenorrhea for at least 4 months
- •biochemical confirmation as evidenced by an elevated FSH level >25IU/L on two occasions > 4 weeks apart
- •Or fluctuating POI when one of the above criteria is missing.
排除标准
- •Subjects who meet one or more of the following will not be considered eligible to participate in the clinical trial:
- •Simultaneous participation in another clinical study that, at the researcher's criteria, could interfere with the results of this study.
- •Autoimmune origin of POI
- •Genetic risk factors for POR (e.g. Turner Syndrome, FMR1 premutation, etc);
- •Acquired conditions associated with POR (e.g. Chemotherapy);
- •Clinical endometriosis
- •Previous ovarian surgery considered as a risk of POR
- •Previous gonadotoxic treatment
- •Known intolerance or allergic reactions to components of the study product, i.e. lactose
研究组 & 干预措施
4-step ASCOT arm
POI women randomized to the 4-step ASCOT technique will receive a direct ovarian injection of G-CSF mobilized and activated PRP. For each patient, both ovaries will be directly injected with the G-CFS activated PRP (4-step ASCOT). Follow up (AFC, AMH, FSH and E2 determinations) will be developed for 6 months and COS initiated if growing antral follicles detected.
干预措施: G-CSF treatment for Bone marrow derived stem cell Mobilization (Drug)
4-step ASCOT arm
POI women randomized to the 4-step ASCOT technique will receive a direct ovarian injection of G-CSF mobilized and activated PRP. For each patient, both ovaries will be directly injected with the G-CFS activated PRP (4-step ASCOT). Follow up (AFC, AMH, FSH and E2 determinations) will be developed for 6 months and COS initiated if growing antral follicles detected.
干预措施: Platelet Rich Plasma ovarian injection (Procedure)
结局指标
主要结局
AFC
时间窗: 6-month
Follicular development assessed by antral follicular count between controls and treated patients after the 4-step ASCOT technique during the follow up period.
次要结局
- Ovarian function (YES/NO)(6-12 months)
- FSH, AMH and E2 levels(6-month)
- Number of COS and IVF cycle parameters for each patient, initiated before and after treatment.(6-month)
- Menses recovery (YES/NO)(6-12 months)