Dehydroepiandrosterone Clinical Trial
Official title:
Effects of Dehydroepiandrosterone Supplementation on Cumulus Cells Gene Expression Under Controlled Ovarian Hyper-stimulation in Patients With Diminished Ovarian Reserve
Verified date | May 2014 |
Source | Taipei Veterans General Hospital, Taiwan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | October 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 40 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Taipei Veteran General Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Taipei Veterans General Hospital, Taiwan | National YangMing University |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | 2 to 4 weeks after embryo transfer. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03438812 -
Dehydroepiandrosterone Maintain Mitochondrial Quality of Cumulus Cells in Poor Ovarian Responders
|
N/A | |
Completed |
NCT04535973 -
Hormonal Status and Quality of Life in Female Postmenopausal Patients With Burning Mouth Syndrome
|
||
Recruiting |
NCT04514731 -
Magnesium Sulfate and Neuroendocrine Hormone
|
Phase 4 |