DehydroepiandrosteronePhase 3NCT02150330
Effects of Dehydroepiandrosterone Supplementation on Cumulus Cells Gene Expression Under Controlled Ovarian Hyper-stimulation in Patients With Diminished Ovarian Reserve
A Phase 3 study testing Dehydroepiandrosterone (DHEAS) in people with Dehydroepiandrosterone and DHEAS, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dehydroepiandrosterone, DHEAS, Gene Expression of Cumulus Cells.
- What is being tested?
- Dehydroepiandrosterone (DHEAS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2013to Oct 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Patient who has the allergic history or contraindication to DHEAS usage.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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)
- Conditions
- Dehydroepiandrosterone, DHEAS, Gene Expression of Cumulus Cells., Ovarian Hyper-stimulation Protocol., Artificial Reproduction Technology.
- Being tested
- Dehydroepiandrosterone (DHEAS)
- Keywords
- Dehydroepiandrosterone, DHEAS, Gene expression of cumulus cells., Folliculogenesis., Oocyte maturation., Ovarian hyper-stimulation protocol., Artificial reproduction technology.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dehydroepiandrosterone (DHEAS)Drug
Also called DHEAS
| Study group | Role | What they receive |
|---|---|---|
| DHEAS in DOR Group | Active comparator | Additional usage of DHEAS supplement in patients with DOR under ovarian hyper-stimulation protocol. Receives: Drug: Dehydroepiandrosterone (DHEAS) |
| Normal Control | Active comparator | Patients under ovarian hyper-stimulation protocol. No DHEAS supplement. Receives: Drug: Dehydroepiandrosterone (DHEAS) |
| Shame DOR Group | Active comparator | Patients with DOR under ovarian hyper-stimulation protocol. No DHEAS supplement. Receives: Drug: Dehydroepiandrosterone (DHEAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
The successful pregnancy outcome is defined as intrauterine gestational sac with positive fetal heart activity on the sonogram.
Measured: 2 to 4 weeks after embryo transfer.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startJan 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DehydroepiandrosteroneStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Collaborators
- National YangMing University
- Responsible party
- Principal investigator, vghtpe user, Taipei Veterans General Hospital, Taiwan
- Investigators
- KuanHao Tusi, M.D., Principal investigator, Kaohsuing Veteran General HospitalPengHui Wang, M.D.,Ph D, Study chair, Taipei Veteran General Hospital, National YangMing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150330
- Sponsor's protocol ID
- VGHKS13-CT11-17
- Status last verified
- May 2014
- First submitted
- 26 May 2014
- Last updated
- 29 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25951716Tsui 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.
PubMed 25510701
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dehydroepiandrosterone Supplementation on Cumulus Cells Gene Expression Under Controlled Ovarian Hyper-stimulation in Patients With Diminished Ovarian Reserve
- ClinicalTrials.gov ID
- NCT02150330
- Acronym / sponsor ID
- VGHKS13-CT11-17
- 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.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Collaborators
- National YangMing University
- Study start
- Jan 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 29 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DHEAS in DOR Group | Active comparator | Drug: Dehydroepiandrosterone (DHEAS)Additional usage of DHEAS supplement in patients with DOR under ovarian hyper-stimulation protocol. |
| Normal Control | Active comparator | Drug: Dehydroepiandrosterone (DHEAS)Patients under ovarian hyper-stimulation protocol. No DHEAS supplement. |
| Shame DOR Group | Active comparator | Drug: Dehydroepiandrosterone (DHEAS)Patients with DOR under ovarian hyper-stimulation protocol. No DHEAS supplement. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Patient who has the allergic history or contraindication to DHEAS usage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dehydroepiandrosterone (DHEAS)Also: DHEAS | Drug | DHEAS in DOR Group, Normal Control, Shame DOR Group |
Primary outcome
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).
1 secondary outcome
Pregnancy outcomes were compared with diminished ovarian reserve and normal control groups after DHEAS supplement.
Time frame: 2 to 4 weeks after embryo transfer.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2014.
- Derived from this study: PubMed 25951716Tsui 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.
- Derived from this study: PubMed 25510701Tsui 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KuanHao Tusi, M.D. principal investigator
Kaohsuing Veteran General Hospital
PengHui Wang, M.D.,Ph D study chair
Taipei Veteran General Hospital, National YangMing University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dehydroepiandrosterone (DHEAS) in people with Dehydroepiandrosterone and DHEAS, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene expressions of culumuls cells under ovarian hyper-stimulation protocol. (time frame: The 3 or 5 days after oocyte retrieval.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02150330, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2014.