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临床试验/NCT03238833
NCT03238833已完成不适用

Department of Obstetrics and Gynecology, Kaohsiung Veterans General Hospital

Kaohsiung Veterans General Hospital.1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2017年5月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
96
试验地点
1
主要终点
oocytes and embryos

研究概览

简要总结

The investigators attempted to compare the clinical outcomes and cumulus genes expression in poor ovarian responders undergoing luteal ovarian stimulation or follicular ovarian stimulation in in vitro fertilization cycles.

详细描述

Multiple follicular wave theory proposed by Baerwald et al. implied that follicle recruitment may occur in the luteal phase of menstrual cycle. Therefore, luteal phase ovarian stimulation (LPOS) was considered as a potential feasible stimulation method during in vitro fertilization (IVF) cycle. In the beginning, in order to avoid delaying cancer treatment, LPOS was applied for fertility preservation of cancer patients, showing no difference in numbers of oocyte retrieved, mature oocytes and fertilization rate between luteal or follicular phase stimulation. In the recent, LPOS was used for infertility women, suggesting that LPOS owned quite good IVF outcomes. In previous studies, premature luteinizing hormone (LH) surge, a major reason worsening ovarian quality in poor ovarian responders (PORs), was seldom found in LPOS. High progesterone in luteal phase may aid in suppressing premature LH surge. An updated research claimed that numbers of oocyte retrieved, mature oocytes and fertilized oocytes in LPOS significantly increased when compared to follicular ovarian stimulation. Therefore, the investigators presumed that LPOS was a more effective method than follicular stimulation in PORs.

研究设计

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

入排标准

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

入选标准

  • •Poor ovarian responders (PORs) met the Bologna criteria, having at least two of the three following features:
  • •advanced maternal age (≥ 40 years) or any other risk factor for POR,
  • •a previous POR (≤ 3 oocytes with a conventional stimulation protocol), and
  • •an abnormal ovarian reserve test. An abnormal ovarian reserve test was defined as antral follicle count (AFC) < 5 or anti-Müllerian hormone (AMH) < 1 ng/mL in this study.
  • •Moreover, two episodes of a previous POR after maximal stimulation alone would be sufficient to define a patient as a POR.

排除标准

  • •oophorectomy
  • •exposure to cytotoxic or pelvic irradiation for malignancy
  • •taking herbal drugs or other hormonal agents

研究组 & 干预措施

luteal ovarian stimulation

Experimental

The controlled ovarian stimulation in in vitro fertilization cycle was started since luteal phase.

干预措施: luteal ovarian stimulation (Other)

follicular ovarian stimulation

Active Comparator

The controlled ovarian stimulation in in vitro fertilization cycle was started since early follicular phase phase.

干预措施: follicular ovarian stimulation (Other)

结局指标

主要结局

oocytes and embryos

时间窗: through study completion, an average of 1 year

retrieved oocytes in number, matured oocytes in number, fertilized oocytes in number, day 3 embryos in number, top-quality day 3 embryos in number

次要结局

  • pregnancy rate(Pregnancy will be confirmed 4 weeks after embryo transfer.)
  • genes expression(through study completion, an average of 1 year)

研究者

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

Li-Te Lin

Department of Obstetrics and Gynecology

Kaohsiung Veterans General Hospital.

研究点 (1)

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