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

Primary Purpose

Dehydroepiandrosterone, DHEAS, Gene Expression of Cumulus Cells.

Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Dehydroepiandrosterone (DHEAS)
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dehydroepiandrosterone focused on measuring Dehydroepiandrosterone, DHEAS, Gene expression of cumulus cells., Folliculogenesis., Oocyte maturation., Ovarian hyper-stimulation protocol., Artificial reproduction technology.

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Taipei Veteran General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

DHEAS in DOR Group

Normal Control

Shame DOR Group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Pregnancy outcomes were compared with diminished ovarian reserve and normal control groups after DHEAS supplement.
The successful pregnancy outcome is defined as intrauterine gestational sac with positive fetal heart activity on the sonogram.

Full Information

First Posted
May 26, 2014
Last Updated
May 26, 2014
Sponsor
Taipei Veterans General Hospital, Taiwan
Collaborators
National YangMing University
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1. Study Identification

Unique Protocol Identification Number
NCT02150330
Brief Title
Effects of Dehydroepiandrosterone Supplementation on Cumulus Cells Gene Expression Under Controlled Ovarian Hyper-stimulation in Patients With Diminished Ovarian Reserve
Official Title
Effects of Dehydroepiandrosterone Supplementation on Cumulus Cells Gene Expression Under Controlled Ovarian Hyper-stimulation in Patients With Diminished Ovarian Reserve
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
Collaborators
National YangMing University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehydroepiandrosterone, DHEAS, Gene Expression of Cumulus Cells., Ovarian Hyper-stimulation Protocol., Artificial Reproduction Technology.
Keywords
Dehydroepiandrosterone, DHEAS, Gene expression of cumulus cells., Folliculogenesis., Oocyte maturation., Ovarian hyper-stimulation protocol., Artificial reproduction technology.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DHEAS in DOR Group
Arm Type
Active Comparator
Arm Description
Additional usage of DHEAS supplement in patients with DOR under ovarian hyper-stimulation protocol.
Arm Title
Normal Control
Arm Type
Active Comparator
Arm Description
Patients under ovarian hyper-stimulation protocol. No DHEAS supplement.
Arm Title
Shame DOR Group
Arm Type
Active Comparator
Arm Description
Patients with DOR under ovarian hyper-stimulation protocol. No DHEAS supplement.
Intervention Type
Drug
Intervention Name(s)
Dehydroepiandrosterone (DHEAS)
Other Intervention Name(s)
DHEAS
Primary Outcome Measure Information:
Title
Gene expressions of culumuls cells under ovarian hyper-stimulation protocol.
Description
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).
Time Frame
The 3 or 5 days after oocyte retrieval.
Secondary Outcome Measure Information:
Title
Pregnancy outcomes were compared with diminished ovarian reserve and normal control groups after DHEAS supplement.
Description
The successful pregnancy outcome is defined as intrauterine gestational sac with positive fetal heart activity on the sonogram.
Time Frame
2 to 4 weeks after embryo transfer.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KuanHao Tusi, M.D.
Organizational Affiliation
Kaohsuing Veteran General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
PengHui Wang, M.D.,Ph D
Organizational Affiliation
Taipei Veteran General Hospital, National YangMing University
Official's Role
Study Chair
Facility Information:
Facility Name
Taipei Veteran General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25951716
Citation
Tsui KH, Lin LT, Chang R, Huang BS, Cheng JT, Wang PH. Effects of dehydroepiandrosterone supplementation on women with poor ovarian response: A preliminary report and review. Taiwan J Obstet Gynecol. 2015 Apr;54(2):131-6. doi: 10.1016/j.tjog.2014.07.007.
Results Reference
derived
PubMed Identifier
25510701
Citation
Tsui KH, Lin LT, Horng HC, Chang R, Huang BS, Cheng JT, Wang PH. Gene expression of cumulus cells in women with poor ovarian response after dehydroepiandrosterone supplementation. Taiwan J Obstet Gynecol. 2014 Dec;53(4):559-65. doi: 10.1016/j.tjog.2014.09.003.
Results Reference
derived

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

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