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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-10-31

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Dehydroepiandrosterone DHEAS Gene Expression of Cumulus Cells. Ovarian Hyper-stimulation Protocol. Artificial Reproduction Technology.

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DHEAS in DOR Group

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

Group Type ACTIVE_COMPARATOR

Dehydroepiandrosterone (DHEAS)

Intervention Type DRUG

Normal Control

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

Group Type ACTIVE_COMPARATOR

Dehydroepiandrosterone (DHEAS)

Intervention Type DRUG

Shame DOR Group

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

Group Type ACTIVE_COMPARATOR

Dehydroepiandrosterone (DHEAS)

Intervention Type DRUG

Interventions

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Dehydroepiandrosterone (DHEAS)

Intervention Type DRUG

Other Intervention Names

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DHEAS

Eligibility Criteria

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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.