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

NCT02150330 | Completed Phase 3 DMC

• 1 other identifier: VGHKS13-CT11-17
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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.

Outcome Measures

Primary Outcomes (1)

• 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).

  The 3 or 5 days after oocyte retrieval.

Secondary Outcomes (1)

• Pregnancy outcomes were compared with diminished ovarian reserve and normal control groups after DHEAS supplement.

  2 to 4 weeks after embryo transfer.

Study Arms (3)

DHEAS in DOR Group

ACTIVE COMPARATOR

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

Drug: Dehydroepiandrosterone (DHEAS)

Normal Control

ACTIVE COMPARATOR

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

Drug: Dehydroepiandrosterone (DHEAS)

Shame DOR Group

ACTIVE COMPARATOR

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

Drug: Dehydroepiandrosterone (DHEAS)

Interventions

Dehydroepiandrosterone (DHEAS) DRUG

Also known as: DHEAS

DHEAS in DOR Group; Normal Control; Shame DOR Group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• National YangMing University: collaborator

Study Sites (1)

Taipei Veteran General Hospital

Taipei, Taiwan, 11217, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 25951716 DERIVED

• 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.

  PMID: 25510701 DERIVED

MeSH Terms

Interventions

Dehydroepiandrosterone

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• KuanHao Tusi, M.D.

  Kaohsuing Veteran General Hospital

  PRINCIPAL INVESTIGATOR

• PengHui Wang, M.D.,Ph D

  Taipei Veteran General Hospital, National YangMing University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Peng-Hui Wang, M.D. Ph D., Department of Obstetrics and Gynecology, Taipei Veterans General Hospital, Taipei, Taiwan, ROC

Study Record Dates

• First Submitted: May 26, 2014
• First Posted: May 29, 2014
• Study Start: January 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: May 29, 2014

Record last verified: 2014-05

Locations

TW (1)