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临床试验/NCT04237909
NCT04237909已完成不适用

Effects of Intraovarian Injection of Autologous Platelet Rich Plasma on Ovarian Reserve and IVF Outcome Parameters in Women With Premature Ovarian Insufficiency and Poor Ovarian Response

Acibadem University2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2020年1月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
500
试验地点
2
主要终点
Ovarian reserve parameters

研究概览

简要总结

Reproductive age women diagnosed with poor ovarian response (POR) based on Poseidon criteria and premature ovarian insufficiency (POI) based on ESHRE criteria and with a history of at least one prior failed IVF cycle will be recruited for the study. Antral follicle count (AFC), serum anti-mullerian hormone (AMH), and early follicular phase serum follicle stimulating hormone (FSH) levels will determined at baseline. Autologous blood obtained from peripheral vein will be used to prepare PRP following standard protocols and will be injected to at least one ovary. Ovarian reserve parameters and IVF outcomes will be determined.

详细描述

Reproductive age women diagnosed with POR based on Poseidon criteria and POI based on European Society of Human Reproduction and Endocrinology (ESHRE) criteria with a history of at least one prior failed IVF cycle will recruited for the study. Antral follicle count (AFC), serum anti-mullerian hormone (AMH), and early follicular phase serum follicle stimulating hormone (FSH) levels will be determined at baseline. Autologous blood obtained from peripheral vein will be used to prepare PRP following standard protocols. PRP injection will be performed under sedation anesthesia, using a 35 cm 17 G needle under transvaginal ultrasound guidance. On the 2-4th days of the first six menstrual cycles following the procedure, AFC, AMH, and FSH levels will be re-assessed. Patients with at least one antral follicle will be started on ovarian stimulation for in-vitro fertilization- intracytoplasmic sperm injection (IVF-ICSI), followed by embryo banking/ preimplantation genetic testing- aneuploidy (PGT-A) or embryo transfer. Markers of ovarian reserve (AFC, FSH, AMH), and IVF laboratory outcome parameters (number of metaphase II (MII) oocytes, 2PN(pronucleus) embryos, cleavage stage, blastocyst embryos) will be followed.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 48 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients with a history of >1 year infertility duration with at least one ovary, who fulfilled the ESHRE criteria,
  • Patients diagnosed with POR based on Poseidon criteria and with a history of at least one prior failed IVF cycle

排除标准

  • Presence of pregnancy,
  • previous diagnosis of any malignancy,
  • ovarian insufficiency secondary to sex chromosome etiology,
  • prior major lower abdominal surgery resulting in pelvic adhesions,
  • anticoagulant use for which plasma infusion is contraindicated,
  • current or previous (Immunoglobulin A (IgA) deficiency

结局指标

主要结局

Ovarian reserve parameters

时间窗: 6 months

Number of participants with intraovarian injection of autologous PRP as assessed by blood hormone analysis and ultrasonographic antral follicle counts, change in serum FSH, AMH levels and number of antral follicle counts.

次要结局

  • Ovarian response to stimulation(12 months)

研究者

发起方
Acibadem University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bulent Tiras

Prof.

Acibadem University

研究点 (2)

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