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)
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
- 是
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
Induction of oocyte maturation with GnRH agonist
干预措施: GnRH agonist (Drug)
hCG trigger
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
Lawrence Engmann
MD
UConn Health
