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临床试验/NCT01009567
NCT01009567已完成1 期

Compare the Efficacy of Human Albumin With Cabergoline to Prevent of Ovarian Hyper Stimulation in ART Program

Royan Institute1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2009年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
10
试验地点
1
主要终点
Percentage and severity of OHSS in two groups

研究概览

简要总结

The purpose of this study is to investigate the efficacy and safety of cabergoline in prevention of ovarian hyperstimulation syndrome versus albumin in ART program.

详细描述

Ovarian hyperstimulation syndrome (OHSS) is a iatrogenic potentially life threatening complication of assisted reproduction technologies due to gonadotropin and human chorionic gonadotropin administration. Its severe form has been reported in 1-10% of in vitro fertilization cycles.

Different strategies have been proposed for the prevention of OHSS in high-risk patients, but these approaches do not offer complete protection against the development of ovarian hyperstimulation syndrome (OHSS). Among the selected preventive methods, discontinuing (coasting) gonadotropin therapy and i.v. albumin were by far the most popular choices. Several previous studies have shown that cabergoline is a safe drug, both for mother and conceptus, for the treatment of macroadenoma hyperprolactinemia. We think that this kind of therapy may be safe both for mother and conceptus (as previously shown by several studies on dopamine agonists treatment of hyperprolactinemia during pregnancy), easier, cheaper and probably, more effective than previous OHSS treatments (albumin, steroids, dopamine). There is an urgent need to test cabergoline efficacy in OHSS prevention in high risk patients with a large multicenter study.

The proposal of This study approved by our institutional review boards and institution's ethical committee, and all Participants will sign a written consent before enter to study. Patients entering the intracytoplasmic sperm injection (ICSI) / IVF program in Royan institute and infertility research center in Valieasr hospital in Iran. We use a downregulation protocol with a GnRH agonist (buserelin acetate) as a long protocol for ICSI/ IVF-ET. We evaluate patients for high risk factors of severe OHSS. The inclusion criterion was the collection of >20 oocytes during oocyte retrieval. They allocate by a series of computer-generated random into two groups after the oocytes retrieval. 30 minutes after oocytes retrieval patients in A Group , receive human albumin 20% infusion and in B group receive cabergoline tablet (0/5 mg) daily until 6 days after oocytes retrieval then women in all groups will informed about the signs and symptoms of OHSS and counsel to contact with our institute if OHSS develops. Patients will monitor routinely 6days after ET by ultrasonographic examination for ovarian size and for detection of ascites. Moderate to severe OHSS patients hospitalize and evaluate routinely by haematological and biochemical tests. OHSS patients diagnose and classify according to Golan et al 1989.we compare incidence of OHSS and severity of OHSS patients in two groups. Pregnant patients follow until the 12th gestational week.

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
25 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • patients at risk of developing OHSS, defined by the development of 20-30 follicles larger than 12 mm in diameter and retrieval of more than 20 oocytes
  • ovarian stimulation with long protocol

排除标准

  • coasting cases

研究组 & 干预措施

Control

Sham Comparator

Receive human albumin 20% infusion

干预措施: Control (Drug)

Cabergoline

Experimental

Receive cabergoline tablet (0/5 mg) daily until 6 days after oocytes retrieval

干预措施: Cabergoline (Drug)

结局指标

主要结局

Percentage and severity of OHSS in two groups

时间窗: 6 days after embryos transfer (ET)

次要结局

  • Efficacy and safety of cabergoline and albumin(6 days after embryos transfer (ET))

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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