Dehydroepiandrosterone (DHEA) Treatment and Premature Ovarian Failure (POF) (DHEAFert2)
Primary Purpose
Premature Ovarian Failure
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dehydroepiandrosterone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Premature Ovarian Failure focused on measuring DHEA, POF, Pregnancy, Ovarian Failure, Otherwise Unexplained infertility, Ovarian aging
Eligibility Criteria
Inclusion Criteria:
- >= 1 year of infertility
- >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 semen analysis
- 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
Sites / Locations
- Center for Human Reproduction
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
DHEA active treatment
DHEA Placebo
Arm Description
Dehydroepiandrosterone 25 mg tid po
Blinded placebo
Outcomes
Primary Outcome Measures
Live Birth
Live Birth
Live Birth outcome compared between DHEA active treatment and Placebo
Secondary Outcome Measures
Endocrine Effects
Androgen Side Effects
Clinical Pregnancy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00948857
Brief Title
Dehydroepiandrosterone (DHEA) Treatment and Premature Ovarian Failure (POF)
Acronym
DHEAFert2
Official Title
A Randomized Double Blinded Trail of DHEA Supplementation for Treatment of Couples With Premature Ovarian Failure (POF).
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Terminated
Why Stopped
Lack of recruitment.
Study Start Date
June 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David H. Barad
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
Informed consent
Baseline studies
Antral follicle counts
Serum FSH, LH, E2, Prog, DHEA, DHEAS, testosterone, AMH, Fragile X
Randomization
Group A: DHEA (25 mg three times per day)
Group B: Placebo
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ovarian Failure
Keywords
DHEA, POF, Pregnancy, Ovarian Failure, Otherwise Unexplained infertility, Ovarian aging
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DHEA active treatment
Arm Type
Experimental
Arm Description
Dehydroepiandrosterone 25 mg tid po
Arm Title
DHEA Placebo
Arm Type
Placebo Comparator
Arm Description
Blinded placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Dehydroepiandrosterone
Other Intervention Name(s)
DHEA
Intervention Description
25 mg PO TID
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Blinded placebo
Primary Outcome Measure Information:
Title
Live Birth
Time Frame
24 months
Title
Live Birth
Description
Live Birth outcome compared between DHEA active treatment and Placebo
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Endocrine Effects
Time Frame
12 months
Title
Androgen Side Effects
Time Frame
12 months
Title
Clinical Pregnancy
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
>= 1 year of infertility
>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 semen analysis
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Barad, MD, MS
Organizational Affiliation
Center for Human Reproduction
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Norbert Gleicher, MD
Organizational Affiliation
Center for Human Reproduction
Official's Role
Study Chair
Facility Information:
Facility Name
Center for Human Reproduction
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.centerforhumanreprod.com/
Description
Center for Human Reproduction
Learn more about this trial
Dehydroepiandrosterone (DHEA) Treatment and Premature Ovarian Failure (POF)
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