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临床试验/NCT02185326
NCT02185326已完成4 期

Growth Hormone Co-treatment With the Microflare Stimulation Protocol in IVF/ICSI, Can it be a New Hope for Poor Responders?

Woman's Health University Hospital, Egypt1 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2014年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
145
试验地点
1
主要终点
Clinical pregnancy rates

研究概览

简要总结

The effect of use of the microflare down regulation protocol on the outcome of the IVF/ICSI cycles in poor responders

详细描述

The microflare as a method of down regulation protocol can be used to prepare the females suffering from poor ovarian reserve to undergo IVF/ICSI cycles. In this study we are trying to outline its effect on the clinical pregnancy rate as a main primary outcome, and to compare its use with the addition of growth hormone to the same protocol.

研究设计

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

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • females fulfilling the criteria of the ESHRE consensus 2011:
  • At least two of the following three features must be present:
  • (i) Advanced maternal age (≥40 years) or any other risk factor for POR; (ii) A previous POR (≤3 oocytes with a conventional stimulation protocol); (iii) An abnormal ovarian reserve test (i.e. AFC ,5-7 follicles or AMH ,0.5 -1.1 ng/ml).

排除标准

  • women who suffer from any other cause of infertility other than poor ovarian reserve
  • refusal of the patient to consent for using her data in the study.

研究组 & 干预措施

Microflare and growth hormone

Experimental

the patients in this group were given oral contraceptive pills (OCPs) for 28 days, this was followed by 2 days free. Triptorelin (Decapeptyl Ferring Pharmaceuticals, Germany) 0.05 mg/day S.C. was then started daily followed by human menopausal gonadotropin IM daily (HMG 75 IU, Merional, IBSA) 3 days later. Growth hormone (Norditropin, Novo nordisk) was administrated on day 6 of HMG stimulation daily in a dose of 2.5 mg S.C. till the day of hCG administration.

干预措施: Growth hormone (Norditropin, Novo nordisk) (Drug)

结局指标

主要结局

Clinical pregnancy rates

时间窗: 15 months

次要结局

未报告次要终点

研究者

发起方
Woman's Health University Hospital, Egypt
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dina Mohamed Refaat Dakhly

Lecturer of obstetrics and gynecology

Woman's Health University Hospital, Egypt

研究点 (1)

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