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

Phase 3

Completed

• Conditions: Dehydroepiandrosterone; DHEAS; Gene Expression of Cumulus Cells.; Ovarian Hyper-stimulation Protocol.; Artificial Reproduction Technology.
• Interventions: Drug: Dehydroepiandrosterone (DHEAS)

• Registration Number: NCT02150330
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-01
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-05
• Study First Submitted: 2014-05-26
• Study First Submitted QC: 2014-05-26
• Last Update Submitted: 2014-05-26
• Study First Posted: 2014-05-29
• Last Update Posted: 2014-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DHEAS in DOR Group	Dehydroepiandrosterone (DHEAS)	Additional usage of DHEAS supplement in patients with DOR under ovarian hyper-stimulation protocol.
Normal Control	Dehydroepiandrosterone (DHEAS)	Patients under ovarian hyper-stimulation protocol. No DHEAS supplement.
Shame DOR Group	Dehydroepiandrosterone (DHEAS)	Patients with DOR under ovarian hyper-stimulation protocol. No DHEAS supplement.

Primary Outcome Measures

Name	Time	Method
Gene expressions of culumuls cells under ovarian hyper-stimulation protocol.	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

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

Trial Locations

Locations (1)

Taipei Veteran General Hospital; 🇨🇳 Taipei, Taiwan