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临床试验/NCT04278313
NCT04278313进行中(未招募)不适用

Randomized Controlled Trial of Ovarian Function Following Intraovarian Injection of Platelet Rich Plasma for Women With Ovarian Aging

Center for Human Reproduction2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年2月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
90
试验地点
2
主要终点
Embryo Transfer

研究概览

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者

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

Experimental

Platelet RICH Plasma prepared using RegenLab FDA approved device.

干预措施: PRP - Platelet Rich Plasma (Procedure)

PPP group

Placebo Comparator

Platelet POOR Plasma prepared using RegenLab FDA approved device.

干预措施: PPP - Platelet Poor Plasma (Procedure)

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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