跳至主要内容
临床试验/NCT02681536
NCT02681536Unknown不适用

Miniflare Versus Long Protocol in Poor Responders

Woman's Health University Hospital, Egypt1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年2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
200
试验地点
1
主要终点
Number of oocytes retrieved

研究概览

简要总结

The study is performed to compare the outcomes of two stimulation protocols, the minidose long protocol versus the microdose flare protocol in poor responders undergoing IVF/ICSI.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • poor responder women who fulfilled the criteria defined by the ESHRE consensus in 2011[4]; Poor responder females are those who possess two out of these three criteria: i) Female age ≥40 years; ii) Females who have at least one previous cancelled IVF cycle; iii) POR according to AFC ≤5 or low AMH value.

排除标准

  • females with FSH more than 20 IU/L
  • females with previous ovarian surgery
  • females suffering from causes of infertility other than poor ovarian response, cases with polycystic ovaries syndrome
  • females refusing to be enrolled in the study, females with any endocrine disorder such as: diabetes, thyroid
  • patients with male factor of infertility.

研究组 & 干预措施

Minidose long protocol

Experimental

Down-regulation started on day 20 of the previous cycle by GnRH agonist triptorelin (0.5 µg Decapeptyl; Ferring). On the second day of menstruation, when down regulation was confirmed (as evidenced by endometrial thickness <5 mm and/or E2 levels <50 pg/mL) using transvaginal sonography (TVS) by Voluson 730 Pro (GE, Fairfield, CT) apparatus, gonadotropin (Merional; IBSA) was commenced at an initial dose of 300-450 IU/day for the first 5 days followed by individual adjustment in Gn dose according to ovarian response and the dose of Decapeptyl 50µg/day was continued until day of HCG administration.

干预措施: Triptorelin (Drug)

Minidose long protocol

Experimental

Down-regulation started on day 20 of the previous cycle by GnRH agonist triptorelin (0.5 µg Decapeptyl; Ferring). On the second day of menstruation, when down regulation was confirmed (as evidenced by endometrial thickness <5 mm and/or E2 levels <50 pg/mL) using transvaginal sonography (TVS) by Voluson 730 Pro (GE, Fairfield, CT) apparatus, gonadotropin (Merional; IBSA) was commenced at an initial dose of 300-450 IU/day for the first 5 days followed by individual adjustment in Gn dose according to ovarian response and the dose of Decapeptyl 50µg/day was continued until day of HCG administration.

干预措施: HMG (Drug)

microdose flare protocol

Experimental

OCPs drospirenone /ethinyl estradiol (Yasmin, BAYER) for not less than 21 days before starting ovarian stimulation, this was followed by 2 days free. Triptorelin (Decapeptyl Ferring Pharmaceuticals, Germany) 0.05 mg/day S.C. was then started daily followed by HMG IM daily (Merional, 75 IU, IBSA) 3 days later. Then the same cycle adjustment was done as the minidose long protocol.

干预措施: Triptorelin (Drug)

microdose flare protocol

Experimental

OCPs drospirenone /ethinyl estradiol (Yasmin, BAYER) for not less than 21 days before starting ovarian stimulation, this was followed by 2 days free. Triptorelin (Decapeptyl Ferring Pharmaceuticals, Germany) 0.05 mg/day S.C. was then started daily followed by HMG IM daily (Merional, 75 IU, IBSA) 3 days later. Then the same cycle adjustment was done as the minidose long protocol.

干预措施: Combined oral contraceptive pills (Drug)

microdose flare protocol

Experimental

OCPs drospirenone /ethinyl estradiol (Yasmin, BAYER) for not less than 21 days before starting ovarian stimulation, this was followed by 2 days free. Triptorelin (Decapeptyl Ferring Pharmaceuticals, Germany) 0.05 mg/day S.C. was then started daily followed by HMG IM daily (Merional, 75 IU, IBSA) 3 days later. Then the same cycle adjustment was done as the minidose long protocol.

干预措施: HMG (Drug)

结局指标

主要结局

Number of oocytes retrieved

时间窗: 6 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)

Loading locations...

相似试验