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临床试验/NCT02061228
NCT02061228终止不适用

Endometrial Receptivity Enhancement Through Induced Injury and Repair During Ovarian Stimulation in an Antagonist Down-regulated Cycle

Universitair Ziekenhuis Brussel1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2014年3月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
200
试验地点
1
主要终点
Clinical pregnancy rate

研究概览

简要总结

A randomised controlled open-label clinical trial to assess the effect of artificially induced endometrial injury and repair during ovarian stimulation on the clinical pregnancy rate of an antagonist downregulated in-vitro fertilisation cycle

详细描述

Ovarian stimulation, ultrasound and hormonal monitoring, ovulation induction, oocyte retrieval, embryology procedure, IVF and luteal support will be according to how they are normally performed in our centre.

All women included will undergo artificial ovarian stimulation with gonadotropin-releasing hormone (GnRH) antagonist downregulation with daily injections of either ganirelix or cetrorelix. Treating physicians will opt on which exogenous gonadotropins should be used according to the patient's profile and preference and can include either recombinant follicle stimulating hormone (FSH) or highly purified urinary human menopausal gonadotropin (HP-HMG). Ovarian stimulation will commence after it is confirmed that the patient is not pregnant and has basal levels of oestradiol, progesterone, FSH and luteinizing hormone (LH). The stimulation will be monitored simultaneously by pelvic ultrasound and hormonal analysis (oestradiol, progesterone), starting on day 6 of stimulation and then every 1 to 3 days, according to the individual endocrine profile and follicular development.

Final oocyte maturation will be triggered with either 5000/10000 IU of human menopausal human chorionic gonadotropin (hCG) or 150 IU of recombinant hCG when more than 2 follicles of ≥17 mm are present. Oocyte retrieval will be performed 36 hours after hCG administration under either local anaesthesia with analgesic premedication or general anaesthesia, according to patient preference.

IVF or IVF/intracytoplasmatic sperm injection (ICSI) will be performed, using the specimen of sperm made available by the male progenitor on the day of oocyte retrieval. According to embryo quality, embryo transfer to the uterine cavity will be performed on either the 3rd or 5th day of development under ultrasound guidance whenever possible. Following embryo transfer, luteal support will be provided with vaginally administered progesterone 200 mg tid.

For clarity, cycle cancelation is defined as any interruption of the ART process that occurs before fresh embryo transfer. Cycle cancelation will occur a) upon patient request, b) if inadequate follicular development occurs, c) if no embryo is available for transfer.

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
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Fresh IVF/ICSI cycle
  • Antagonist down-regulation
  • Signed informed consent

排除标准

  • Other known reasons for impaired implantation (i.e. hydrosalpinx, fibroid distorting the endometrial cavity, Asherman's syndrome, thrombophilia or endometrial tuberculosis)
  • Oocyte donation acceptors
  • Frozen egg transfers
  • Embryos planned to undergo preimplantation genetic diagnosis (PGD)
  • BMI >35 or <18
  • Women already recruited for another trial on medically assisted procreation during the same cycle
  • Women who have previously enrolled in the trial
  • Those unable to comprehend the investigational nature of the proposed study

结局指标

主要结局

Clinical pregnancy rate

时间窗: 12 weeks

Sample size calculation was based on the adequate sample which would simultaneously 1) allow two safety-check interim analyses (at one-third and two-thirds of recruitment) and 2) have an 80% power to detect an increase of 15% in clinical pregnancy rate (from 32% to 47%) in the intervention group \[using a two-side Fisher-exact test with a significance level (alfa) of 0.05\]. Using a 1:1 randomisation ratio, each group would require approximately 180 patients, adding up to a total of 360 patients required for the trial.

次要结局

  • Live-birth rate(42 weeks)
  • Complication rate(42 weeks)
  • Effect on the endometrial histology and expression(2 weeks)

研究者

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

Samuel Santos-Ribeiro

MD

Universitair Ziekenhuis Brussel

研究点 (1)

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