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临床试验/NCT02200952
NCT02200952已完成不适用

Luteal Phase Supplementation With Recombinant LH After GnRh Agonist Oocytes Triggering in Women at Risk of OHSS

San Carlo Public Hospital, Potenza, Italy2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2013年6月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
16
试验地点
2
主要终点
Pregnancy Rate and Implantation Rate

研究概览

简要总结

The purpose of this study is to prove that luteal phase supplementation with recombinant LH can solve the luteal phase deficiency after Gnrh agonist oocytes triggering in women at risk of OHSS

详细描述

The investigators enrolled patients, undergoing controlled ovarian stimulation for an IVF/ICSI cycles, who on the day of oocytes triggering were at risk of OHSS.

These patients had an estradiol > 4000 pg/ml and more than 24 follicles with a diameter greater than 12 mm.

The investigators used 0,2 mg of triptorelin for the oocytes triggering and supplemented the luteal phase with recombinant LH at a dose of 75 UI twice/day for 10 days and vaginal gel progesterone and oral oestradiol for 14 days The investigators measured bhCG at 14 days from the pick up. In case of positive bhCG we have defined the IVF/ICSI outcome: Pregnancy Rate and Implantation Rate.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 43 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • patients with an oestradiol > 4000 pg/ml on the oocytes triggering day
  • patient with more than 24 follicles of diameter greater than 12 mm on the oocytes triggering day

排除标准

  • patients with no risk of OHSS on the oocytes triggering day
  • patients with an oestradiol < 4000 pg/ml on the oocytes triggering day
  • patient with less than 24 follicles of diameter greater than 12 mm on the oocytes triggering day

研究组 & 干预措施

Patients at risk of OHSS

Patients at risk of OHSS on the oocytes triggering day with an oestradiol > 4000pg/ml or a number of follicles greater than 24 of a diameter greater than 12 mm

干预措施: recombinant LH (Drug)

结局指标

主要结局

Pregnancy Rate and Implantation Rate

时间窗: From 14 days after the pick up to six weeks of gestation

We measured bhCG after 14 days from the pick up. In presence of a positive value of bhCG we evaluated IVF/ICSI outcome through the pregnancy rate and implantation rate.

次要结局

  • Ealy and Late Ovarian Hyperstimulation Syndrome(From 9 days after pick up to 12 weeks of gestation)

研究者

发起方
San Carlo Public Hospital, Potenza, Italy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Assunta Iuliano, MD

MD, PhD

San Carlo Public Hospital, Potenza, Italy

研究点 (2)

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