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

May 26, 2014 updated by: vghtpe user, Taipei Veterans General Hospital, Taiwan
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 11217
        • Taipei Veteran General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: DHEAS in DOR Group
Additional usage of DHEAS supplement in patients with DOR under ovarian hyper-stimulation protocol.
Drug: Dehydroepiandrosterone (DHEAS)
Other Names:
  • DHEAS
Active Comparator: Normal Control
Patients under ovarian hyper-stimulation protocol. No DHEAS supplement.
Drug: Dehydroepiandrosterone (DHEAS)
Other Names:
  • DHEAS
Active Comparator: Shame DOR Group
Patients with DOR under ovarian hyper-stimulation protocol. No DHEAS supplement.
Drug: Dehydroepiandrosterone (DHEAS)
Other Names:
  • DHEAS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
The 3 or 5 days after oocyte retrieval.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 to 4 weeks after embryo transfer.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Collaborators

National YangMing University

Investigators

  • Principal Investigator: KuanHao Tusi, M.D., Kaohsuing Veteran General Hospital
  • Study Chair: PengHui Wang, M.D.,Ph D, Taipei Veteran General Hospital, National YangMing University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

May 26, 2014

First Submitted That Met QC Criteria

May 26, 2014

First Posted (Estimate)

May 29, 2014

Study Record Updates

Last Update Posted (Estimate)

May 29, 2014

Last Update Submitted That Met QC Criteria

May 26, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGHKS13-CT11-17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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