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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2013

Detailed Description

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)

Interventions

  • Drug: Dehydroepiandrosterone (DHEAS)

Arms, Groups and Cohorts

  • Active Comparator: DHEAS in DOR Group
    • Additional usage of DHEAS supplement in patients with DOR under ovarian hyper-stimulation protocol.
  • Active Comparator: Normal Control
    • Patients under ovarian hyper-stimulation protocol. No DHEAS supplement.
  • Active Comparator: Shame DOR Group
    • Patients with DOR under ovarian hyper-stimulation protocol. No DHEAS supplement.

Clinical Trial Outcome Measures

Primary Measures

  • Gene expressions of culumuls cells under ovarian hyper-stimulation protocol.
    • Time Frame: 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).

Secondary Measures

  • Pregnancy outcomes were compared with diminished ovarian reserve and normal control groups after DHEAS supplement.
    • Time Frame: 2 to 4 weeks after embryo transfer.
    • The successful pregnancy outcome is defined as intrauterine gestational sac with positive fetal heart activity on the sonogram.

Participating in This Clinical Trial

Inclusion Criteria

  • DOR: antral follicle count (AFC) less than 5, AntiMullerian hormone (AMH) less than 1.0 ng/ml, and previous total retrieved oocyte less than 5. – 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 5. Patient provided signed informed consent. Exclusion Criteria:

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

Gender Eligibility: Female

Minimum Age: 20 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Taipei Veterans General Hospital, Taiwan
  • Collaborator
    • National YangMing University
  • Provider of Information About this Clinical Study
    • Principal Investigator: 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
  • Overall Official(s)
    • KuanHao Tusi, M.D., Principal Investigator, Kaohsuing Veteran General Hospital
    • PengHui Wang, M.D.,Ph D, Study Chair, Taipei Veteran General Hospital, National YangMing University

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