The Effect of DHEA on Markers of Ovarian Reserve in Women With Diminished Ovarian Reserve
This study is currently recruiting participants.
Verified February 2013 by Virginia Center for Reproductive Medicine
Sponsor:
Virginia Center for Reproductive Medicine
Information provided by (Responsible Party):
Fady I. Sharara, M.D, Virginia Center for Reproductive Medicine
ClinicalTrials.gov Identifier:
NCT01129830
First received: May 19, 2010
Last updated: February 10, 2013
Last verified: February 2013
| Tracking Information | |||||
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| First Received Date ICMJE | May 19, 2010 | ||||
| Last Updated Date | February 10, 2013 | ||||
| Start Date ICMJE | January 2010 | ||||
| Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
live birth rate [ Time Frame: 3 years ] [ Designated as safety issue: No ] Live birth rate will be monitored for women who took DHEA supplementation |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01129830 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
number of oocytes [ Time Frame: 3 years ] [ Designated as safety issue: No ] Number of retrieved oocytes for patients undergoing IVF will be monitored along with ovarian response |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Effect of DHEA on Markers of Ovarian Reserve in Women With Diminished Ovarian Reserve | ||||
| Official Title ICMJE | The Effect of DHEA on Markers of Ovarian Reserve in Women With Diminished Ovarian Reserve | ||||
| Brief Summary | This prospective study evaluates the effect of DHEA supplementation on markers of ovarian reserve in women with diminished ovarian reserve. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 0 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Infertility | ||||
| Intervention ICMJE | Dietary Supplement: dehydroepiandrosterone
DHEA supplementation 25 mg tid for 3 months |
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| Study Arm (s) | Dehydroepiandrosterone
infertile women with low anti mullerian hormone levels
Intervention: Dietary Supplement: dehydroepiandrosterone |
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| 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. Epub 2007 Dec 11. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | January 2014 | ||||
| Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 21 Years to 44 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01129830 | ||||
| Other Study ID Numbers ICMJE | VCRM 3 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Fady I. Sharara, M.D, Virginia Center for Reproductive Medicine | ||||
| Study Sponsor ICMJE | Virginia Center for Reproductive Medicine | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Virginia Center for Reproductive Medicine | ||||
| Verification Date | February 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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