Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2025-12-29 @ 6:42 PM
Study NCT ID:
NCT00948857
Status:
TERMINATED
Last Update Posted:
2012-09-10
First Post:
2009-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dehydroepiandrosterone (DHEA) Treatment and Premature Ovarian Failure (POF)
Sponsor:
David H. Barad
Organization:
Study Overview
Official Title:
A Randomized Double Blinded Trail of DHEA Supplementation for Treatment of Couples With Premature Ovarian Failure (POF).
Status:
TERMINATED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of recruitment.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DHEAFert2
Brief Summary:
The experimental focus of this project is on the interaction of DHEA treatment on pregnancy in women with open tubes, fertile male partners and evidence of premature ovarian failure.
Detailed Description:
Recruitment:
* 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
* 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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: