Study of Oral Dehydroepiandrosterone(DHEA) to Treat Previously Unexplained Infertility (DHEAFert)
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).
Premature Ovarian Aging
Dietary Supplement: Dehydroepiandrosterone
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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).|
- Live Birth [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Endocrine effects [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Androgen side effects [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Clinical Pregnancy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2008|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
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.
Dietary Supplement: Dehydroepiandrosterone
25 mg PO TID
Other Name: DHEA
Placebo Comparator: Placebo
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.
- Informed consent
- 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
- Primary Outcome
- 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 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
|Contact: David Barad, MD, MS||212 994-4400||dbarad@theCHR.com|
|Contact: Jolanta Tapper||212 994-4400||jtapper@theCHR.com|
|United States, New York|
|Center for Human Reproduction||Recruiting|
|New York, New York, United States, 10021|
|Contact: Jolanta Tapper 212-994-4400 jtapper@theCHR.com|
|Contact: Susan 212 994-4400 jgu@theCHR.com|
|Principal Investigator: David Barad, MD, MS|
|Sub-Investigator: Norbert Gleicher, MD|
|Principal Investigator:||David Barad, MD, MS||Center for Human Reproduction|
|Study Chair:||Norbert Gleicher, MD||Center for Human Reproduction|