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An Observational Study to Evaluate Efficacy, Safety and Clinical Outcomes of Currently Used Pharmaceutical Therapies for Controlled Ovarian Stimulation in Assisted Reproductive Techniques (ESCORT)

2014年9月12日 更新者:Merck KGaA, Darmstadt, Germany

An Observational Program to Evaluate Efficacy, Safety and Clinical Outcomes of Currently Used Pharmaceutical Therapies for Controlled Ovarian Stimulation (COS) in Assisted Reproductive Techniques (ART)

Human gonadotrophins have been successfully used for the treatment of infertility for more than 30 years. This observational study is being conducted to evaluate the efficacy and safety of the gonadotropins used for controlled ovarian stimulation (COS) in assisted reproductive technologies (ART).

研究概览

地位

完全的

条件

详细说明

The objective of this observational program is to evaluate the efficacy and safety of the gonadotropins used for COS in ART. The clinical use of the various progesterone preparations will also be monitored and registered. All medications will be used according to normal clinical practice, as described in the Summary of Product Characteristics (SmPC). From the start of the program cycles data will be collected prospectively for 12 months and also a substantial amount of cycles will be analyzed retrospectively for the previous 6 months. Data will be collected from all subjects stimulated by follicle stimulating hormone (FSH), with or without down regulation and exogenous lutenizing hormone (LH) supplementation, and final follicular maturation triggered by human chorionic gonadotropin (hCG) and luteal phase support by any means for COS in ART and intracytosolic sperm injection (ICSI). All the medications should be used according to usual clinical practice. Data related to pretreatment (basal examination, history of infertility, LH suppression), stimulation (gonadotropin use, concomitant medications, luteal phase supplementation, ovulation triggering, cycle cancellation, fertilization methods), safety aspects and clinical outcome will be captured.

研究类型

观察性的

注册 (实际的)

10103

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Istenhegyi út 54/A
      • Budapest、Istenhegyi út 54/A、匈牙利、1125
        • Kaáli Institute

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

有资格学习的性别

女性

取样方法

非概率样本

研究人群

Female subjects undergoing ART

描述

Inclusion Criteria:

  • This is a registry wherein data will be collected from all subjects stimulated by FSH, with- or without down regulation and exogenous luteinising hormone (LH) supplementation, and final follicular maturation triggered by hCG and luteal phase support by any means for controlled ovarian stimulation (COS) in assisted reproductive technique (ART) and intracytoplasmic sperm injection (ICSI).

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Efficacy of gonadotropins will be assessed by pregnancy outcome
大体时间:From the start of the program cycles up to 12 months (data will be collected prospectively for 12 months and also a substantial amount of cycles will be analyzed retrospectively for the previous 6 months)
Duration and dose of gonadotropin; ovulation triggering; cycle cancellation reasons; clinical pregnancy at week 8; gestational sac size; foetal heart beat; ectopic pregnancy; early pregnancy loss; ongoing pregnancy with fresh and frozen embryos; pregnancy outcome (number, weight, length and percentile of born children); endometrial thickness; number of oocytes per retrieval; size of leading follicle; number of oocytes fertilized; total number of embryos; number of fresh embryos transferred; fertilization rate; number of cryopreserved embryos per FET; mean quality score of transferred embryos.
From the start of the program cycles up to 12 months (data will be collected prospectively for 12 months and also a substantial amount of cycles will be analyzed retrospectively for the previous 6 months)
Safety assessments include recording of adverse events (AEs), serious adverse events (SAEs), AE resulting in cancellation, drug related AEs, ovarian hyperstimulation syndrome [OHSS (mild, moderate, severe, none)].
大体时间:From the start of the program cycles up to 12 months (data will be collected prospectively for 12 months and also a substantial amount of cycles will be analyzed retrospectively for the previous 6 months)
From the start of the program cycles up to 12 months (data will be collected prospectively for 12 months and also a substantial amount of cycles will be analyzed retrospectively for the previous 6 months)

次要结果测量

结果测量
大体时间
Clinical outcomes of the various progesterone preparations will be monitored and registered by assessing clinical pregnancy
大体时间:From the start of the program cycles up to 12 months (data will be collected prospectively for 12 months and also a substantial amount of cycles will be analyzed retrospectively for the previous 6 months)
From the start of the program cycles up to 12 months (data will be collected prospectively for 12 months and also a substantial amount of cycles will be analyzed retrospectively for the previous 6 months)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Péter Kovács, MD、Kaáli Institute, Budapest

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2009年6月1日

初级完成 (实际的)

2013年12月1日

研究完成 (实际的)

2013年12月1日

研究注册日期

首次提交

2010年5月28日

首先提交符合 QC 标准的

2010年6月22日

首次发布 (估计)

2010年6月23日

研究记录更新

最后更新发布 (估计)

2014年9月15日

上次提交的符合 QC 标准的更新

2014年9月12日

最后验证

2014年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 700623-506

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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