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临床试验/NCT01606709
NCT01606709终止4 期

A Prospective Comparison of Transcriptional Profiling of Luteal Phase Endometrial Biopsies After Induction of Oocyte Maturation With a Gonadotropin Releasing Hormone (GnRH) Agonist or Human Chorionic Gonadotropins (hCG)

UConn Health1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2012年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
发起方
入组人数
7
试验地点
1
主要终点
Endometrial Gene Expression Profile

研究概览

简要总结

The purpose of this study is to compare gene expression profiles in endometrial biopsies during the window of implantation after triggers of oocyte maturation using GnRH agonist or hCG and compared with their natural cycles in order to identify genes that may be dysregulated in GnRH agonist-triggered cycles.

The investigators also intend to evaluate patients feeling of well being and physical quality of life after GnRH agonist trigger compared with hCG trigger.

详细描述

Ovarian hyperstimulation syndrome (OHSS) is an iatrogenic complication of controlled ovarian hyperstimulation (COH) which may result in significant morbidity and rarely mortality as well as significant financial and psychological distress. The use of a GnRH agonist for induction of final oocyte maturation in ovarian stimulation cycles utilizing GnRH antagonist for pituitary suppression has proven to be an effective method of preventing the risk of OHSS development.

Unfortunately, some studies, but not all, have also reported lower pregnancy rates in these cycles as compared to cycles using hCG trigger and this has been attributed to possible impaired endometrial receptivity.

The investigators intend to obtain endometrial biopsies collected from the same subject in a natural cycle and then a biopsy during either a GnRH agonist or hCG triggered stimulation. Expression profiles of mRNAs will first be screened using microarray technology. Relative levels of specific mRNAs that display altered expression in the GnRH-triggered samples, as assayed by microarray, will then be confirmed by real-time, quantitative reverse transcription/polymerase chain reaction (Q-PCR). The investigators shall also evaluate patients feeling of well being and physical quality of life after GnRH agonist trigger compared with hCG trigger.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Investigator)

入排标准

年龄范围
21 Years 至 33 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Oocyte donors
  • Ages between 21 and 33
  • Normal baseline serum FSH < 10mIU/mL

排除标准

  • Hypothalamic dysfunction
  • Baseline serum FSH ≥ 10mIU/mL

研究组 & 干预措施

GnRH agonist trigger

Experimental

Induction of oocyte maturation with GnRH agonist

干预措施: GnRH agonist (Drug)

hCG trigger

Active Comparator

Induction of oocyte maturation with hCG

干预措施: hCG (Drug)

结局指标

主要结局

Endometrial Gene Expression Profile

时间窗: 7 days after trigger of oocyte maturation

Microarray of gene expression in the midluteal phase

次要结局

  • Quality of Life Survey After Ovarian Stimulation and GnRHa or hCG Trigger(At baseline and up to 7 days after trigger of oocyte maturation)

研究者

发起方
UConn Health
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lawrence Engmann

MD

UConn Health

研究点 (1)

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