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Trial record 12 of 235 for:    PRASTERONE

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

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ClinicalTrials.gov Identifier: NCT02150330
Recruitment Status : Completed
First Posted : May 29, 2014
Last Update Posted : May 29, 2014
Sponsor:
Collaborator:
National YangMing University
Information provided by (Responsible Party):
vghtpe user, Taipei Veterans General Hospital, Taiwan

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.

Condition or disease Intervention/treatment Phase
Dehydroepiandrosterone DHEAS Gene Expression of Cumulus Cells. Ovarian Hyper-stimulation Protocol. Artificial Reproduction Technology. Drug: Dehydroepiandrosterone (DHEAS) Phase 3

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Dehydroepiandrosterone Supplementation on Cumulus Cells Gene Expression Under Controlled Ovarian Hyper-stimulation in Patients With Diminished Ovarian Reserve
Study Start Date : January 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Prasterone

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 Name: DHEAS

Active Comparator: Normal Control
Patients under ovarian hyper-stimulation protocol. No DHEAS supplement.
Drug: Dehydroepiandrosterone (DHEAS)
Other Name: DHEAS

Active Comparator: Shame DOR Group
Patients with DOR under ovarian hyper-stimulation protocol. No DHEAS supplement.
Drug: Dehydroepiandrosterone (DHEAS)
Other Name: DHEAS




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02150330


Locations
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Taiwan
Taipei Veteran General Hospital
Taipei, Taiwan, 11217
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
National YangMing University
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: 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
ClinicalTrials.gov Identifier: NCT02150330     History of Changes
Other Study ID Numbers: VGHKS13-CT11-17
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: May 29, 2014
Last Verified: May 2014
Keywords provided by vghtpe user, Taipei Veterans General Hospital, Taiwan:
Dehydroepiandrosterone
DHEAS
Gene expression of cumulus cells.
Folliculogenesis.
Oocyte maturation.
Ovarian hyper-stimulation protocol.
Artificial reproduction technology.
Additional relevant MeSH terms:
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Ovarian Hyperstimulation Syndrome
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs