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临床试验/NCT05478616
NCT05478616终止不适用

To Investigate the Expression of Endometrium During Window of Implantation Between Natural Cycles and Artificial Cycles

Kaohsiung Veterans General Hospital.1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
3
试验地点
1
主要终点
Expression of endometrium

研究概览

简要总结

The aim of this study was to investigate the expression of endometrium during window of implantation between natural cycles and artificial cycles.

详细描述

Due to progress of embryo vitrification in recent years, frozen embryo transfer (FET) of in vitro fertilization (IVF) has already been a world trend. The most used two protocols of FET are natural cycles (NCs) and artificial cycles (ACs). Recent studies showed that IVF outcomes of NCs were superior to ACs. We hypothesized that the result may be because of better endometrial receptivity of NCs compared to ACs. In NCs, no hormonal agents were administrated. Thus, endometrial receptivity was not disturbed by hormone and became better. However, there were few studies to explore the issue. Therefore, the aim of this study was to investigate the expression of endometrium during window of implantation (WOI) between NCs and ACs.

The study will be performed from July 1st, 2022 to December 31th, 2023 in our reproductive center. We plan to enroll 60 infertile women who have underwent IVF cycles and would like to receive endometrial receptivity assay. We divide the participants into two groups, NCs and ACs. In NCs, no hormonal agents will be used. We identify ovulation day via serial hormone data and sample endometrium during WOI (LH surge + 7 days). In ACs, first, estrogen will be given for 10~14 days and then transvaginal sonography will be conducted. When endometrial thickness reaches 8 mm at least, progesterone will be prescribed. Endometrium is sampled during WOI (P4 + 5 days). We will record basic characteristics, infertility history, hormone data, ovarian reserve and endometrial thickness of infertile women in both groups. Endometrial samples will be assessed miRNA, implantation factors, uterine NK cells and T cells in both groups.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
30 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age: 30-44 years
  • BMI: 18~30 kg/m2
  • Implantation failure at least two times

排除标准

  • Primary ovarian insufficiency
  • Congenital uterine anomaly
  • Severe intrauterine adhesion
  • Malignancy
  • Donor cycle

结局指标

主要结局

Expression of endometrium

时间窗: through study completion, an average of 1.5 year

miRNA

次要结局

  • Implantation factors of endometrium(through study completion, an average of 1.5 year)
  • Immune cells of endometrium(through study completion, an average of 1.5 year)

研究者

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

Li-Te Lin

Attending doctor, Department of Obstetrics and Gynecology, Principal Investigator, Assistant professor

Kaohsiung Veterans General Hospital.

研究点 (1)

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