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临床试验/NCT03402620
NCT03402620已完成不适用

Starting Dose of Gonadotropin for Poor Responders in IVF Cycles

Cairo University1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2018年1月11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
入组人数
102
试验地点
1
主要终点
number of retrieved oocytes

研究概览

简要总结

infertile , poor responders patients who underwent ICSI. The participants were divided into 2 groups according to the starting dose of Gn stimulation. Group I started with 4 ampoules while group II started with 6 ampoules

详细描述

Participants will be randomized to start induction with 4 or 6 ampoules of gonadotropins from day 2 till the day of human chorionic gonadotropin (HCG), dose adjusted according to ovarian response monitored by serum E2 and ultrasound evaluation. All patients were followed up by TVUS scan daily or on alternate days according to the ovarian response to treatment starting on treatment cycle day 6 for folliculometry and endometrial thickness and pattern. Cetrotide (MerckSerono, Germany) 0.25 subcutaneously will be added when the leading follicle (DF) reaches >12 mm and HCG 10 000 IU intramuscularly (Pregnyl, Merck Sharp, United Kingdom)will be given only if we have at least 3 mature follicles >14 mm and the leading one >17 mm; then, ovum pickup (OPU) was done after 36 hours of HCG and metaphase II ocytes were analyzed. The intracytoplasmic sperm injection (ICSI) procedure will be performed in all cases to avoid low fertilization rate by conventional IVF. Fertilization was assessed 16 to 18 hours after ICSI, and embryo quality will be evaluated 2 and 3 days after ICSI according to the number of blastomeres and the degree of fragmentation and multinucleation. Oocytes were collected and embryos will be cultured in ISM1 culture medium (Origiomedicult media, Denmark). Transfer of cleaving embryos will be done on day 3 after oocyte retrieval (using Labotect semirigid catheter; labotect GmbH, Germany), when the woman has at least 1 embryo (GI) otherwise canceled embryo transfer (ET). The ET was done by 1 person in each center. Both of the transferring consultants have more than 5 years experience in IVF unit. . All patients will receive luteal support in the form of daily progesterone cyclogest (Actavis, United Kingdom) 800 mg daily starting from day of ovum retrieval till day of hCG testing. Serum b hCG level was assessed on day 14 after ET and considered positive if >5 mIU/ml. The TVUS was performed 28 days after ET to confirm ongoing pregnancy by visualization of intrauterine sac.

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 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Poor responders according to "Bologna consensus" with at least 2 of the following 3 points should be present:
  • Age >40 years or other cause of poor function.
  • AFC<2-5 in both ovaries or AMH < 0.5-1.1 ng/dl 2)
  • History of poor response with conventional stimulation protocol

排除标准

  • Uterine factor.
  • Severe male factor.
  • Endometriosis.

研究组 & 干预措施

four ampoules group

Active Comparator

gonadotropin starting dose is 4 ampoules daily

干预措施: Gonadotropins (Drug)

six ampoules group

Active Comparator

gonadotropin starting dose is 6 ampoules daily

干预措施: Gonadotropins (Drug)

结局指标

主要结局

number of retrieved oocytes

时间窗: 34 hours after HCG triggering

The number of oocyte retrived at ovum pickup

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Maged

professor

Cairo University

研究点 (1)

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