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临床试验/NCT03887728
NCT03887728已完成不适用

Comparison of Blood Flow in the Arteriae Uterinae in Ovarian Stimulation Cycles for IVF/ICSI, in Hormonal Replacement Cycles and Natural Cycles for Frozen Embryo Transfer

ART Fertility Clinics LLC1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2019年4月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
124
试验地点
1
主要终点
Difference in the blood flow, calculated as Pulsatility Index (PI) and Resistance Index (RI), between the HRT- and the NC-FET cycles

研究概览

简要总结

This study will measure the blood flow in the aa. uterinae in women, undergoing firstly ovarian stimulation for In-Vitro Fertilization (IVF) / Intracytoplasmic sperm injection (ICSI), in Hormonal Replacement cycles (HRT) and Natural cycles (NC) for Frozen Embryo Transfer (FET)

详细描述

To evaluate the influence of ovarian stimulation on the blood flow in the arteriae uterinae as well as whether there is an influence of the type of endometrial preparation for FET with either hormonal replacement therapy or natural cycle on the blood flow of the arteria uterina left / right

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Patients who undergo ovarian stimulation in a Gonadotropin-Releasing-Hormone (GnRH)-antagonist protocol for IVF / ICSI
  • Patients who have vitrified embryo(s)
  • Preparation for FET either in HRT or NC cycle

排除标准

  • Poor responder according to Bologna criteria (Ferraretti et al.) as follows:
  • At least two of the following three features must be present:
  • (i) Advanced maternal age (≥40 years) or any other risk factor for poor ovarian reserve (POR);
  • (ii) A previous POR (≤3 oocytes with a conventional stimulation protocol);
  • (iii) An abnormal ovarian reserve test (i.e. antral follicle count (AFC) 5-7 follicles or anti-mullerian hormone (AMH) 0.5 -1.1 ng/ml).
  • Uterine surgery for removal of fibroids (hysteroscopic, laparoscopic) or removal of uterine septum
  • Endometriosis
  • Asherman-Syndrome
  • Previous cytotoxic treatment
  • Previous radiation of the uterus / adnexal region
  • Known hypertension
  • Intake of Aspirin or similar medication which might influence the blood flow
  • Status after tubal ligation
  • Status after surgery in the adnexal region on 1 side

结局指标

主要结局

Difference in the blood flow, calculated as Pulsatility Index (PI) and Resistance Index (RI), between the HRT- and the NC-FET cycles

时间窗: 1 day

On the day of progesterone administration / progesterone rise. Quantitative continuous variable

次要结局

  • Number of days of estradiol exposure(1 day)
  • Continuous quantitative variable measured as the differences between average RI value(2 days)
  • Thickness of the lining(1 day)
  • Continuous quantitative variable measured as the differences between average PI value(1 day)

研究者

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

Barbara Lawrenz

Scientific Director

ART Fertility Clinics LLC

研究点 (1)

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