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临床试验/NCT02202278
NCT02202278Unknown不适用

Serum Levels of IMA, TAC, TOS, OSI and MDA in Severe OHSS Patients Underwent Long Agonist Protocol Intracytoplasmic Sperm for Determining Oxidative Stress Status

Karadeniz Technical University1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
25
试验地点
1
主要终点
Change the levels of oxidative stress markers

研究概览

简要总结

The aim of the study is to determine serum oxidative stress status by ischemia modified albumin (IMA), total antioxidant capacity (TAC), total oxidative capacity (TOS), oxidative stress capacity (OSI), and serum malondialdehyde (MDA) in patients with OHHS and control group. We also aim to reveal the association between serum levels of these factors and oocyte quality.

详细描述

  • Patients included in this study were assisted reproductive technique (ART) patients with moderate and severe OHSS who were hospitalized for management
  • Control patients are selected from patients without signs of OHSS
  • All patients are administered luteal long protocol for controlled ovarian stimulation. Pituitary down-regulation with SC injection of GnRH agonist (GnRH-a) (1 mg/day; Lucrin, Abbott Laboratories, North Chicago, IL) that was started on day 21 of the previous menstrual cycle. Subcutaneous administration of recombinant hFSH (Gonal-F, Laboratories Serono S.A., Aubonne, Switzerland) at dosages from 150-225 IU/day is initiated on the second or third day of menstruation.
  • When there are at least two or three follicles >17 mm in diameter, recombinant human chorionic gonadotropin (0.25 µgr ; Ovitrelle IM, Serono, Istanbul, Turkey) is applied subcutaneously 34-36 hours before oocyte retrieval.
  • Serum samples are collected on day of HCG for study and control group patients.
  • Serum levels of ischemia modified albumin (IMA), malondialdehyde (MDA), total oxidative capacity (TOS), total antioxidative capacity (TAS) and oxidative stress capacity (OSI) levels.
  • This is a case control study
  • Statistical analyses will be performed using student t-test and fisher chi-square test. The correlations between the serums IMA, TAC, TOC, OSI, and MDA levels will be examined in all study groups using Spearman correlation analysis.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients in both groups are normoresponders or hyperresponders who will undergo assisted reproductive technology for male factor

排除标准

  • known inherited or acquired thrombophilia
  • previous thromboembolism
  • previous, current or planned anti-thrombotic treatment
  • first degree relatives with known genetic thrombophilia
  • systemic diseases

结局指标

主要结局

Change the levels of oxidative stress markers

时间窗: 1 day

Serum will be obtained for studiying ischemia modified albumin (IMA), malondialdehyde (MDA), total oxidative capacity (TOS), total antioxidative capacity (TAS) and oxidative stress capacity (OSI) levels

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

emine seda guvendag guven

medical doctor

Karadeniz Technical University

研究点 (1)

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