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临床试验/NCT02150330
NCT02150330已完成3 期

Effects of Dehydroepiandrosterone Supplementation on Cumulus Cells Gene Expression Under Controlled Ovarian Hyper-stimulation in Patients With Diminished Ovarian Reserve

Taipei Veterans General Hospital, Taiwan1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
40
试验地点
1
主要终点
Gene expressions of culumuls cells under ovarian hyper-stimulation protocol.

研究概览

简要总结

Diminished ovarian reserve (DOR) is one the challenge in the field of artificial reproductive technology (ART) while there is still no effective resolution of this disorder. In patents with DOR, the pregnancy rate is about only 2-4%. Eventually, patients with DOR turn to adapt children instead. In recent studies, dehydroepiandrosterone (DHEAS) supplement might play a role in reverse diminished ovarian reserve and improve the prognosis of ART. Cumulus cells, formed cumulus-oocyte complex (COC) with oocyte, play a important role in folliculogenesis, oocyte maturation, oocyte meiosis and ovulation. Growing evidences disclose there are crosstalks between oocyte and cumulus cells as paracrine regulations. Aberration the crosswalks between oocytes and cumulus cells would be associated with poor prognosis of folliculogenesis and further pregnancy outcomes. In patients under ovarian hyper-stimulation protocol, the assessment of cumulus cells might be reliable indicators of folliculogenesis, embryo development, pregnancy rate and pregnancy outcomes. These genes (indicators), such as Hyaluronan synthase(HAS2), Versican (VCAN), Thrombospondin 1 (THBS1), Runt-related transcription factor 2 (RUNX2), Chromobox homolog 3 (CBX3),Tripartite motif-containing 28 (TRIM28), B-cell lymphoma 2 (BCL2),BCL2-associated X protein (BAX). This study was assess the gene expressions of cumulus cells after the DHEAS supplement in patients with DOR under ovarian hyper stimulation protocol.

详细描述

This study was designed as a prospective case-control study to assess the gene expression of cumulus cells after DHEAS supplement. Patients with diminished ovarian reserve under ovarian hyper-stimulation protocol were evaluated at Kaoshiung Veteran General Hospital from January 1, 2013 through October 31, 2013. Approval for the study was obtained from the hospital's ethic committee, and informed consent was obtained from all patients (VGHKS13-CT11-17)

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

入选标准

  • DOR: antral follicle count (AFC) less than 5, AntiMullerian hormone (AMH) less than 1.0 ng/ml, and previous total retrieved oocyte less than
  • Normal Control: antral follicle count (AFC) equal to or more than 5, AntiMullerian hormone (AMH) equal to or more than 1.0 ng/ml, and previous total retrieved oocyte equal to or more than
  • Patient provided signed informed consent.

排除标准

  • Patient who has the allergic history or contraindication to DHEAS usage.

研究组 & 干预措施

DHEAS in DOR Group

Active Comparator

Additional usage of DHEAS supplement in patients with DOR under ovarian hyper-stimulation protocol.

干预措施: Dehydroepiandrosterone (DHEAS) (Drug)

Normal Control

Active Comparator

Patients under ovarian hyper-stimulation protocol. No DHEAS supplement.

干预措施: Dehydroepiandrosterone (DHEAS) (Drug)

Shame DOR Group

Active Comparator

Patients with DOR under ovarian hyper-stimulation protocol. No DHEAS supplement.

干预措施: Dehydroepiandrosterone (DHEAS) (Drug)

结局指标

主要结局

Gene expressions of culumuls cells under ovarian hyper-stimulation protocol.

时间窗: The 3 or 5 days after oocyte retrieval.

Assessment of gene expressions of cumulus cells, including Hyaluronan synthase (HAS2), Versican (VCAN), Thrombospondin 1(THBS1), Runt-related transcription factor 2 (RUNX2), Chromobox homolog 3 (CBX3), Tripartite motif-containing 28 (TRIM28), B-cell lymphoma 2 (BCL2), BCL2-associated X protein (BAX).

次要结局

  • Pregnancy outcomes were compared with diminished ovarian reserve and normal control groups after DHEAS supplement.(2 to 4 weeks after embryo transfer.)

研究者

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

vghtpe user

Peng-Hui Wang, M.D. Ph D., Department of Obstetrics and Gynecology, Taipei Veterans General Hospital, Taipei, Taiwan, ROC

Taipei Veterans General Hospital, Taiwan

研究点 (1)

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