- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00650754
Study of Oral Dehydroepiandrosterone(DHEA) to Treat Previously Unexplained Infertility (DHEAFert)
A Randomized Double Blinded Trail of DHEA Supplementation for Treatment of Couples With Normal Hysterosalpingogram and Normal Semen Analysis and Evidence of Premature Ovarian Aging (POA).
Study Overview
Status
Intervention / Treatment
Detailed Description
Recruitment:
Eligible patients will be recruited by advertising on the web and in newspaper. We will screen women under 38 years old with regular menstrual cycles and more than one year of infertility.
Experimental plan:
- Informed consent
Baseline studies
- Antral follicle counts on Day 2 - 3 of cycle
- Day 3 Serum FSH, LH, E2, Prog, DHEA, DHEAS, testosterone, AMH, Fragile X
Randomization for pretreatment
- 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 pretreatment
- Compare antral follicle counts across pretreatment cycles between groups
- Compare possible androgen related effects
- Power considerations:
- Power assumptions: alpha 0.05; 80% power
- Pregnancy rate for unexplained infertility is 2% per cycle.
- Intervention will improve pregnancy rate to 5% per cycle.
- Patients will be treated for 8 cycles.
- Cumulative pregnancy rate for control patients - 13%
- Cumulative pregnancy rate for Treated patients - 30%
- Require 91 patients to complete treatment in each group.
- Allow for 20% dropout ( 91* 1.2) will need 109 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 8 months and possible natural continued loss of fertility
- Informed consent issues
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Center For Human Reproduction
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- >= 1 year of infertility
- < 38 years old
- Normal HSG
- Normal Semen analysis (Count >= 20 million/ motility > 50%/ Kruger morph > 14%.
- Regular menses
- Willingness to sign informed consent for study randomization
- Willingness to participate in 8 months of non-IVF will he him treatment.
Exclusion Criteria:
- Abnormal semen analysis
- Abnormal HSG
- Baseline FSH/E2 within normal age specific criteria
- 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 eight months of this trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DHEA
Dehydroepiandrosterone (DHEA) administered at a dose of 25 mg tid po.
DHEA is a weak androgen produced naturally by the adrenal in men and women.
DHEA production is diminished with increasing age.
Peak levels of DHEA occur in the late teenage years.
|
25 mg PO TID
Other Names:
|
Placebo Comparator: Placebo
Blinded placebo
|
Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Live Birth
Time Frame: 24 months
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical Pregnancy
Time Frame: 12 months
|
12 months
|
Endocrine effects
Time Frame: 12 months
|
12 months
|
Androgen side effects
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Norbert Gleicher, MD, Center For Human Reproduction
- Principal Investigator: David Barad, MD, MS, Center For Human Reproduction
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHR2008 1.0
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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