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临床试验/NCT02642601
NCT02642601Unknown2 期

Role of Indomethacin in Cases of Difficult Embryo Transfer in Intra Cytoplasmic Sperm Injection Cycles

Cairo University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
100
试验地点
2
主要终点
clinical pregnancy rate

研究概览

简要总结

the aim of the study is to assess the role of indomethacin in cases of difficult embryo transfer in intracytoplasmic sperm injection cycles.

详细描述

It is a prospective randomized study in which 200 women undergoing ICSI( intracytoplasmic sperm injection) and fulfilling the inclusion criteria(Difficult mock embryo transfer on day of ovum pick up ,Women's age 20-38 yaears,Early follicular FSH ≤10 IU/l ,Tubal, male infertility, unexplained factors of infertility.) will be recruited.

All patients will received long stimulation protocol ;down regulation will be achieved by administration of triptorelin0.1 mg(decapeptyl 0.1 mg, Ferring, Malmo, sweden) S.C daily from day 21 of the cycle preceding the stimulation cycle till the day of hCG administration.,down regulation will be checked day 2 of stimulation cycle by checking serum E2˂50 pg/ml, endometrial thickness ˂ 5mm and quiescent both ovaries.

When down regulation is achieved stimulation is commenced using hmG(Menogon, ferring pharmaceuticals, Germany) 225 IU daily intramuscular injection, Serial trans-vaginal ultrasound to assess follicular growth and serum E2 are done starting on day 6 of the cycle and onward, with adjustments of gonadotropin dose and monitoring frequency based on patient response.

Once 3 or more leading follicles reached≥18mm hCG 10000 IU (Pregnyl; NV Organon) will be administrated IM.

Ovum pick up will be done 34-36 hours following hCG administration with ultrasound guidance under general anesthesia.after that mock embryo transfer will be done using labotec embryo transfer catheter and women in which any degree of difficulty according to Tomas et al. 2002 criteria will be recruited in the study and divided randomly into two groups according to computer generated random cards ;group A (n=100): will receive indomethacin 100 mg rectal supp(KAHIRA PHARMA&CHEM,IND,CO.CAIRO-EGYPT) 1-2 hours before embryo transfer, group B (n=100) will not receive any medications before embryo transfer.

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
20 Years 至 38 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Infertile patients undergoing ICSI cycle with difficult mock transfer done on day of day of ovum pick up

排除标准

  • repeated ICSI failure
  • Easy mock embryo transfer on day of ovum pick up
  • Early follicular FSH >10 IU/l
  • Past history of allergy to NSAID.
  • Past history of asthma, peptic ulcer disease or inflammatory bowel disease. Endometrial pathology

研究组 & 干预措施

indomethacin

Experimental

one dose of indomethacin 100 mg rectal suppository;will be adminstrated1-2 hours before embryo transfer

干预措施: Indomethacin(KAHIRA PHARMA&CHEM,IND,CO.CAIRO-EGYPT) (Drug)

结局指标

主要结局

clinical pregnancy rate

时间窗: 2 weeks after +ve pregnancy test

+ve pregnancy test+ gestational sac with fetal pulsation by ultrasound

次要结局

  • Implantation rate(the number of total gestational sacs divided by the total number of embryos transferred.)

研究者

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

Mona M Shaban

Dr

Cairo University

研究点 (2)

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