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临床试验/NCT00349258
NCT00349258已完成4 期

A Prospective Randomized Study Comparing the Use of hCG or GnRH Agonist to Trigger Final Oocyte Maturation in High Responders Undergoing in-Vitro Fertilization Treatment

University of Connecticut1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2004年8月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
66
试验地点
1
主要终点
OHSS occurrence assessed one week after oocyte retrieval

研究概览

简要总结

To compare the incidence of ovarian hyperstimulation syndrome (OHSS) and implantation rate between high responder patients using Gonadotropin releasing GnRH) agonist or human chorionic gonadotropin (hCG) to trigger final oocyte maturation.

详细描述

OHSS is an iatrogenic complication of controlled ovarian hyperstimulation, which in its severe form, may result in significant morbidity. Although, there have been significant advances in in-vitro fertilization (IVF) protocols over the years, the incidence of OHSS have remained stable and there is currently no effective way of preventing this disorder.

hCG is commonly used as a substitute for the endogenous LH surge to induce final oocyte maturation in IVF. Unfortunately, hCG results in a prolonged luteotropic effect because of its long half-life which may result in a potential risk of OHSS in high-risk patients. In contrast, induction of endogenous LH surge with a GnRH agonist may result in a reduced risk of OHSS. This is due both to the shorter half-life of the endogenous LH surge and the subsequent pituitary suppression leading to early luteolysis. However, previous studies have suggested that this approach may impair implantation rates.

There are no randomized studies assessing the effect of GnRH agonist to induce oocyte maturation on the occurrence of OHSS and implantation rates in high-risk patients. The aims of this study are to compare the incidence of OHSS and implantation rates among high-risk patients who used either GnRH agonist or hCG to trigger oocyte maturation after prevention of premature LH surge with either a GnRH antagonist protocol or the dual pituitary suppression protocol, respectively.

High risk patients include women with polycystic ovarian syndrome (PCOS) or PCO morphology (PCOM) on ultrasound without the clinical or biochemical evidence of the syndrome, and patients with previous high response to gonadotropins.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
20 Years 至 39 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •age 20-39
  • •normal early follicular phase serum FSH (≤10.0 IU/l)
  • •patients with either PCOS or PCOM undergoing their first cycle of IVF or patients with high response in a previous IVF cycle.

排除标准

  • •Hypogonadotropic hypogonadism

结局指标

主要结局

OHSS occurrence assessed one week after oocyte retrieval

Implantation rate assessed at seven weeks gestation

次要结局

  • Clinical Pregnancy rate assessed at time of ultrasound
  • Mature oocytes assessed at time of retrieval
  • Ovarian volume assessed one week after oocyte retrieval

研究者

申办方类型
Other

研究点 (1)

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