跳至主要内容
临床试验/NCT06048666
NCT06048666尚未招募3 期

Effect of Intra-ovarian Injection of Autologous Platelet Rich Plasma on Ovarian Reserve Parameters and Intra Cytoplasmic Sperm Injection Outcomes in Patients With Diminished Ovarian Reserve

Beni-Suef University2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2023年10月30日最近更新:
适应症

试验速览

阶段
3 期
状态
尚未招募
入组人数
56
试验地点
2
主要终点
number of retrieved oocytes

研究概览

简要总结

The aim of this study is to evaluate the efficacy of intra ovarian injection of autologous platelet rich plasma on ovarian reserve parameters and ICSI outcomes in poor ovarian reserve.

详细描述

fifty_six infertile women suffering from poor ovarian reserve &following up at IVF Unit of Beni_suef University hospital. , and they fulfilled inclusion and exclusion criteria. they will be classlfied into two groups: Group A (study group) (involve 28 patient ):will be injected intra ovarian by platelet rich plasma Group B (control group) (involve 28 patient): will not be injected intra ovarian by platelet rich Plasma

The researcher will introduce himself to all participants included in this study and requested that they participate after explaining the purpose of the study. All participants will be given detailed information about the study's goal and predicted advantages. All participants will give their informed verbal agreement, and the data will be kept confidential. All patients will be subjected to:

Complete history was taken with special emphasis on:

Personal ,past,family&surgical history. Menstrual historyObstetric history

Clinical examination:

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
20 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women under the age of
  • have been infertile for more than a year
  • have had at least one previous unsuccessful (or cancelled) IVF cycle.
  • having one of the criteria of poor ovarian response including anti mullerian hormone (AMH) level <1.1 ng /ml ,the antral follicle count of two ovaries in vaginal ultrasound <7 .

排除标准

  • pregnancy(ruled out and documented before PRP injection) . Hydrosalpinex,uterine malformations and abnormal uterine cavity.
  • Partner with severe male factor
  • Ongoing malignancy.
  • Chronic pelvic pain
  • A history of major lower abdomen surgeries that resulted in pelvic adhesions.

结局指标

主要结局

number of retrieved oocytes

时间窗: 1 month of induction for ICSI trial

number of oocytes obtained in ovum pick up

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sara Abdallah Mohamed Salem

principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Beni-Suef University

研究点 (2)

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