InfertilityEarly Phase 1NCT01129830
The Effect of DHEA on Markers of Ovarian Reserve in Women With Diminished Ovarian Reserve
A Early Phase 1 study testing dehydroepiandrosterone in people with Infertility, run by Virginia Center for Reproductive Medicine at 1 site in United States.
Trial summary
This prospective study evaluates the effect of DHEA supplementation on markers of ovarian reserve in women with diminished ovarian reserve. Read more about this study
- Who is it for?
- Ages 21 to 44 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- dehydroepiandrosterone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Sep 2014
- Phase
- Early Phase 1
- 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 21 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- infertile women with diminished ovarian reserve
Who cannot join
- women > 45
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Center for Reproductive Medicine
Reston, Virginia, 20190
About this study
This prospective study evaluates the effect of DHEA supplementation on markers of ovarian reserve in women with diminished ovarian reserve.
Read the detailed description
Ovarian reserve markers, such as FSH, estradiol, AMH, ovarian volume and antral follicle counts will be monitored on DHEA supplementation in a prospective fashion.
- Conditions
- Infertility
- Being tested
- dehydroepiandrosterone
- Keywords
- ovarian reserve, FSH, anti-mullerian hormone, estradiol, oocyte, IVF, embryo transfer
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dehydroepiandrosteroneDietary supplement
DHEA supplementation 25 mg tid for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Dehydroepiandrosterone | Other | infertile women with low anti mullerian hormone levels Receives: Dietary Supplement: dehydroepiandrosterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
live birth rate
Live birth rate will be monitored for women who took DHEA supplementation
Measured: 3 years
Secondary outcomes (1)
number of oocytes
Number of retrieved oocytes for patients undergoing IVF will be monitored along with ovarian response
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2014
- Study completionSep 2014
Why it stopped: Suboptimal recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Center for Reproductive Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fady I. Sharara, M.D, Virginia Center for Reproductive Medicine
- Investigators
- Fady I Sharara, M.D, Principal investigator, Virginia Center for Reproductive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129830
- Sponsor's protocol ID
- VCRM 3
- Status last verified
- Sep 2014
- First submitted
- 19 May 2010
- Last updated
- 22 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Barad D, Brill H, Gleicher N. Update on the use of dehydroepiandrosterone supplementation among women with diminished ovarian function. J Assist Reprod Genet. 2007 Dec;24(12):629-34. doi: 10.1007/s10815-007-9178-x. Epub 2007 Dec 11.
PubMed 18071895
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of DHEA on Markers of Ovarian Reserve in Women With Diminished Ovarian Reserve
- ClinicalTrials.gov ID
- NCT01129830
- Acronym / sponsor ID
- VCRM 3
- Conditions
- Infertility
- Keywords
- ovarian reserve, FSH, anti-mullerian hormone, estradiol, oocyte, IVF, embryo transfer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Suboptimal recruitment
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Virginia Center for Reproductive MedicineUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 25 May 2010 (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.
This prospective study evaluates the effect of DHEA supplementation on markers of ovarian reserve in women with diminished ovarian reserve.
Detailed description
Ovarian reserve markers, such as FSH, estradiol, AMH, ovarian volume and antral follicle counts will be monitored on DHEA supplementation in a prospective fashion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dehydroepiandrosterone | Other | Dietary Supplement: dehydroepiandrosteroneinfertile women with low anti mullerian hormone levels |
Who may qualify
- Ages
- 21 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- infertile women with diminished ovarian reserve
Key exclusion criteria (1 listed)
- women > 45
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 |
|---|---|---|
| dehydroepiandrosteroneDHEA supplementation 25 mg tid for 3 months | Dietary supplement | Dehydroepiandrosterone |
Primary outcome
live birth rate
Time frame: 3 years
Live birth rate will be monitored for women who took DHEA supplementation
1 secondary outcome
number of oocytes
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Suboptimal recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2014.
- Background: PubMed 18071895Barad D, Brill H, Gleicher N. Update on the use of dehydroepiandrosterone supplementation among women with diminished ovarian function. J Assist Reprod Genet. 2007 Dec;24(12):629-34. doi: 10.1007/s10815-007-9178-x. Epub 2007 Dec 11.
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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.
Fady I Sharara, M.D principal investigator
Virginia Center for Reproductive Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing dehydroepiandrosterone in people with Infertility, run by Virginia Center for Reproductive Medicine at 1 site in United States.
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 1 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: stopped early, as of the sponsor's last update on 22 Sep 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 United States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was stopped early (reason given: Suboptimal recruitment). Results are not available in the source record.
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?
live birth rate (time frame: 3 years). 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 NCT01129830, which also lists 1 linked publication.
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 22 Sep 2014.