Dehydroepiandrosterone (DHEA) Treatment and Premature Ovarian Failure (POF)
NCT ID: NCT00948857
Last Updated: 2012-09-10
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2/PHASE3
5 participants
INTERVENTIONAL
2009-06-30
2011-10-31
Brief Summary
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Detailed Description
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* New patients presenting for Donor egg cycles
* Possible print, magazine or Radio advertisement
Experimental plan:
1. Informed consent
2. Baseline studies
* Antral follicle counts
* Serum FSH, LH, E2, Prog, DHEA, DHEAS, testosterone, AMH, Fragile X
3. Randomization
* Group A: DHEA (25 mg three times per day)
* Group B: Placebo
4. Monitoring during treatment
* All participants will have:
* USG for follicle measurement
* Repeat serum, FSH, E2, DHEA, DHEAS, testosterone, AMH monthly during treatment.
* Physical examination
* Completion of study questionnaire regarding possible androgen effects of treatment
5. Analysis plan:
* Primary Outcome
* Pregnancy
* Pregnancy rates will be compared using logistic regression with age and pre-treatment AMH as covariates.
* Secondary Outcomes
* Endocrine Factors
* Androgen side effects
* Primary analysis. We will perform a factorial ANOVA for the two pretreatment factors DHEA and Placebo. Baseline AMH and age as main covariates
* Secondary analysis.
* Examine rate of change of estradiol and other endocrine response over the four cycles of treatment
* Compare antral follicle counts across cycles between groups
* Compare possible androgen related effects
* Power considerations:
* Power assumptions: alpha 0.05; 80% power
Spontaneous Pregnancy rate for POF is less than 1% per 3 months Intervention will improve pregnancy rate to 10% per 3 months. Patients will be treated for 3 cycles. Require 100 patients to complete treatment in each group. Allow for 20% dropout will need 120 patients randomized to each group
* Randomization:
Randomization will be by permuted blocks in order to maintain an even distribution among the groups (because of the small numbers of participants)
* Human subjects issues
* Potential risks associated with DHEA use
* Potential risk of delay of treatment for 3 months and possible natural continued loss of fertility
* Informed consent issues
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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DHEA active treatment
Dehydroepiandrosterone 25 mg tid po
Dehydroepiandrosterone
25 mg PO TID
DHEA Placebo
Blinded placebo
Placebo
Blinded placebo
Interventions
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Dehydroepiandrosterone
25 mg PO TID
Placebo
Blinded placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* \>21 and \<40 years old
* Normal HSG
* Normal Semen analysis (Count \>= 20 million/ motility \> 50%/ Kruger morph \> 14%.
* Absent menses
* Willingness to sign informed consent for study randomization
* Willingness to participate in 3 months of treatment.
Exclusion Criteria
* Abnormal HSG
* Medical condition that would contraindicate pregnancy, ovulation induction or general anesthesia
* Family history of significant genetic disease, or factor V leiden thrombophilia
* Inability to present for monitoring visits
* Inability to follow medication instruction
* Desire to undergo other fertility treatments before completing three months of this trial
21 Years
39 Years
FEMALE
Yes
Sponsors
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David H. Barad
OTHER
Responsible Party
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David H. Barad
Director of Clinical Research
Principal Investigators
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David Barad, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Center for Human Reproduction
Norbert Gleicher, MD
Role: STUDY_CHAIR
Center for Human Reproduction
Locations
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Center for Human Reproduction
New York, New York, United States
Countries
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Related Links
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Center for Human Reproduction
Other Identifiers
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092508-01
Identifier Type: -
Identifier Source: org_study_id