Ovarian Rejuvenation Through Intra-ovarian Injection of Platelet Rich Plasma for Women With Premature Ovarian Insufficiency (POI) and Poor Ovarian Response (POR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- number of participants with a mature oocyte retrieved- POI group
研究概览
简要总结
The objective of this study is to perform a prospective randomized controlled trial seeking to characterize the effects of intra-ovarian injection of platelet rich plasma (PRP) on biomarkers of ovarian reserve as well as IVF outcomes in women with primary ovarian insufficiency (POI) and poor ovarian response (POR) who decline the use of an egg donor to establish a pregnancy.
详细描述
Patients will be randomized to either receive the intra-ovarian PRP injection procedure or not. Regardless of randomization patients will be re-assessed at the same time points for ovarian reserve parameters. If antral follicles are detected at follow up, patients will undergo controlled ovarian hyperstimulation and a routine in vitro fertilization cycle as per protocol.
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
- •POI according to ESHRE criteria (patient must fit both criteria):
- •presence of menstrual disturbance defined as oligo/amenorrhea for at least 4 months
- •biochemical confirmation as evidenced by an elevated FSH level >25 IU/L on two occasions > 4 weeks apart
- •POR defined by at least two prior cycles with POR (≤3 oocytes retrieved with a conventional stimulation protocol, or a cancelled cycle due to poor response)
- •Patients declining ovum donation treatment
排除标准
- •Age <18yo or >38yrs
- •Autoimmune or sex chromosome etiology of POI
- •Ongoing malignancy
- •Previous ovarian surgery
- •Previous gonadotoxic treatment
- •Anticoagulant use for which plasma infusion is contraindicated
- •FMR1 mutations
- •If the duration of the amenorrhea is more than 2 years, patients are discouraged to participate, although it is not an exclusion criterion.
- •Patients with only 1 ovary
- •Male partner with <100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable)
- •Surgically obtained sperm
- •Presence of hydrosalpinges that communicate with endometrial cavity
- •Single gene disorder or chromosomal rearrangement requiring a more detailed embryonic genetic analysis
- •Diagnosis of endometrial insufficiency: prior cycle with maximal endometrial thickness ≤ 6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), persistent endometrial fluid
- •Use of a gestational carrier
- •Any contraindications to undergoing in vitro fertilization or gonadotropin stimulation
- •Known ovaries that are not accessible transvaginally.
- •Ovarian endometrioma(s) or dermoid cyst(s) identified via transvaginal ultrasound
- •FSH > 40iu/l
研究组 & 干预措施
Intervention Group
Patients randomized to this group will receive the intra-ovarian platelet rich plasma injection
干预措施: intra-ovarian platelet rich plasma injection (Other)
Control Group
Patients randomized to this group will not receive the intra-ovarian platelet rich plasma injection
结局指标
主要结局
number of participants with a mature oocyte retrieved- POI group
时间窗: 24 hours post egg retrieval procedure
success or failure is determined by the retrieval of at least one mature oocyte
number of mature oocytes retrieved- POR group
时间窗: 24 hours post egg retrieval procedure
the total number of mature oocytes retrieved
次要结局
未报告次要终点