Primary Ovarian Insufficiency Clinical Trial
— DHEAFertOfficial 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).
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).
Status | Terminated |
Enrollment | 35 |
Est. completion date | March 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 21 Years to 37 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Center for Human Reproduction | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Center for Human Reproduction |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Live Birth | 24 months | No | |
Secondary | Endocrine effects | 12 months | No | |
Secondary | Androgen side effects | 12 months | Yes | |
Secondary | Clinical Pregnancy | 12 months | No |
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