Randomized Controlled Trial of Ovarian Function Following Intraovarian Injection of Platelet Rich Plasma for Women With Ovarian Aging
概览
- 阶段
- 不适用
- 干预措施
- PRP - Platelet Rich Plasma
- 疾病 / 适应症
- Diminished Ovarian Reserve
- 发起方
- Center for Human Reproduction
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Embryo Transfer
- 状态
- 进行中（未招募）
- 最后更新
- 3个月前
概览
简要总结
Consenting women with evidence of poor ovarian reserve will be randomly assigned to treatment with either Platelet Rich Plasma (PRP) or Platelet Poor Plasma (PPP).
详细描述
As women age oocytes are gradually depleted with a consequent progressive loss of ovarian function and fertility. When a woman's follicle cohort falls below a critical level, she enters a transitional time of diminished ovarian reserve known as ovarian aging. Recently the use of autologous platelet-rich plasma (A-PRP) has been proposed as an additional strategy for improving ovarian function. A-PRP is prepared from autologous blood using an FDA approved device. The rationale for the use of PRP is that it contains growth factors which stimulate cellular anabolism, inflammatory modulators that create an anti-inflammatory effect and fibrinogen which acts as a scaffold for regenerating tissue. The investigators hypothesize that the growth factors present in PRP may have a beneficial effect promoting growth and recruitment of antral follicles. The investigators will recruit a prospective cohort of 90 patients with evidence of Premature Ovarian Aging/DOR. Women invited to participate in this RCT will have FSH above 12 and AMH below 1.0 ng/mL respectively and will have had fewer than 6 oocytes retrieved in a previous ovulation attempt. Consenting participants in this trial will be randomized in a doubly blind fashion to two groups. One will receive Platelet Rich Plasma (PRP) and the other will receive Platelet Poor Plasma (PPP). Women assigned to PPP will be offerred PRP in a future cycle if they so desire.
研究者
入排标准
入选标准
- •fewer than 6 oocytes in response to past ovulation induction
- •desire to establish a pregnancy using IVF
- •Age 44 years and under.
- •FSH \> 12
- •AMH \< 1.0
- •No Aspirin or Motrin for one week before treatment
排除标准
- •Age \> 45 years
- •Marked thrombocytopenia
- •Blood diseases
- •Hypofibrinogenemia
- •Hemodynamic instability
- •Anticoagulant or antiaggregant treatment
- •Oncological diseases (specially, skeletal system and blood)
- •Acute and chronic infectious diseases
- •Autoimmune diseases, for example, lupus erythematosus, etc.
研究组 & 干预措施
PRP group
Platelet RICH Plasma prepared using RegenLab FDA approved device.
干预措施: PRP - Platelet Rich Plasma
PPP group
Platelet POOR Plasma prepared using RegenLab FDA approved device.
干预措施: PPP - Platelet Poor Plasma
结局指标
主要结局
Embryo Transfer
时间窗: 6 weeks
Number of participants with at least one day-3 embryo 8-cell with less than 5% fragmentation in an IVF cycle
次要结局
- Embryos Produced(6 weeks)
- AMH(4 weeks)
- Antral Follicle Count(4 weeks)