Study of Oral Dehydroepiandrosterone(DHEA) to Treat Previously Unexplained Infertility (DHEAFert)
Primary Purpose
Primary Ovarian Insufficiency, Unexplained Infertility
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 Primary Ovarian Insufficiency focused on measuring DHEA, Pregnancy
Eligibility Criteria
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
Sites / Locations
- Center for Human Reproduction
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
DHEA
Placebo
Arm Description
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.
Blinded placebo
Outcomes
Primary Outcome Measures
Live Birth
Secondary Outcome Measures
Endocrine effects
Androgen side effects
Clinical Pregnancy
Full Information
NCT ID
NCT00650754
First Posted
March 31, 2008
Last Updated
September 28, 2015
Sponsor
Center for Human Reproduction
1. Study Identification
Unique Protocol Identification Number
NCT00650754
Brief Title
Study of Oral Dehydroepiandrosterone(DHEA) to Treat Previously Unexplained Infertility
Acronym
DHEAFert
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
Failure to recruit designed nuimebrt of subjects
Study Start Date
March 2008 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center for Human Reproduction
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 otherwise unexplained infertility and evidence of premature ovarian aging (POA).
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Ovarian Insufficiency, Unexplained Infertility
Keywords
DHEA, Pregnancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DHEA
Arm Type
Experimental
Arm Description
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.
Arm Title
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
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Live Birth
Time Frame
24 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
37 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
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
Study of Oral Dehydroepiandrosterone(DHEA) to Treat Previously Unexplained Infertility
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