Dehydroepiandrosterone (DHEA) Treatment and Premature Ovarian Failure (POF)

Phase 2

Terminated

Conditions: Premature Ovarian Failure

Interventions: Dietary Supplement: Dehydroepiandrosterone
Dietary Supplement: Placebo

Registration Number: NCT00948857

Lead Sponsor: David H. Barad

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:

1. Informed consent

2. Baseline studies

* Antral follicle counts

* Serum FSH, LH, E2, Prog, DHEA, DHEAS, testosterone, AMH, Fragile X

3. Randomization

* Group A: DHEA (25 mg three times per day)

* Group B: Placebo

4. 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

5. 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

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 5

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