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临床试验/NCT02022241
NCT02022241Unknown不适用

Repeated Injection of GnRH Agonist for Triggering Final Oocyte Maturation in Patients at High Risk of Ovarian Hyperstimulation Syndrome in GnRH Antagonist Protocol

Chenshiling1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2012年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
1
主要终点
Oocyte maturity

研究概览

简要总结

Gonadotropin releasing hormone (GnRH) agonist is sufficient for triggering final oocyte maturation in GnRH antagonist protocol and can significantly reduce incidence of ovarian hyperstimulation syndrome (OHSS) in high-risk patients.

However, lower oocyte yield was reported in patients with lower luteinizing hormone (LH) level post trigger with single injection of GnRH agonist, which might be related to the shorter duration and lower amount of LH induced by GnRH agonist.

Our aim is to study repeated injection of GnRH agonist for preventing OHSS and maintaining clinical outcome in high risk patients who receive controlled ovarian stimulation in GnRH antagonist protocol.

详细描述

This was a prospective cohort study of all women attending the Center for Reproductive Medicine, Department of Gynecology and Obstetrics, Nanfang Hospital, affiliated with Southern Medical University for in vitro fertilization and/or intracytoplasmic sperm injection . Women at high risk of OHSS who received IVF and/or intracytoplasmic sperm injection (ICSI) treatment with a flexible GnRH antagonist protocol were recruited to participate in this study.

All patients underwent standard ovarian stimulation protocol with gonadotropins, standard individualized adjustment of medication dose, and standard egg retrieval procedure. Patients were triggered with a single bolus of 0.2 mg triptorelin at night and had second injection of 0.2 mg triptorelin 12 hours later when the criteria for administration of the ovulation trigger were met.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 40 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • patients with polycystic ovarian syndrome
  • patients with polycystic ovarian morphology on ultrasound
  • patients who previously experienced an ovarian stimulation cycle, with a high response to gonadotrophins

排除标准

  • patients undergoing coasting
  • patients with past ovarian surgery

研究组 & 干预措施

Repeated GnRHa

Experimental

Patients were triggered with repeated GnRHa

干预措施: triptorelin (Drug)

结局指标

主要结局

Oocyte maturity

时间窗: 24 hours post oocyte retrieval day

Oocyte maturity was defined as the ratio of metaphase II (MII) oocytes to the number of collected oocytes in the patients undergoing with ICSI.

clinical pregnancy rate per transfer cycle

时间窗: 1month post embryo transfer

numbers of patients having OHSS

时间窗: 2 weeks post trigger with repeated GnRHa

oocyte yield

时间窗: oocyte retrieval day (34 to 38 hours post the first trigger with GnRHa)

Oocyte yield was defined as the ratio of the total number of collected oocytes to the number of follicles measuring ≥10 mm on the day of oocyte retrieval.

次要结局

  • serum luteinizing hormone level 12 hours post first trigger(12 hours post trigger with the first injection of GnRHa)
  • serum luteinizing hormone level 24 hours post first trigger(24 hours post the first injection of GnRHa)
  • fertilization rate(48 hours post IVF/ICSI)
  • implantation rate(1 month post embryo transfer)

研究者

发起方
Chenshiling
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Chenshiling

Professor, M.D., Ph.D.

Nanfang Hospital, Southern Medical University

研究点 (1)

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