Dehydroepiandrosterone (DHEA) Treatment and Premature Ovarian Failure (POF) (DHEAFert2)

David H. Barad

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Premature Ovarian Failure

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Dehydroepiandrosterone

Study type: Interventional

Funder types: Other

Identifiers

NCT00948857

092508-01

Details and patient eligibility

About

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.

Full 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

Enrollment: 5 patients

Sex: Female

Ages: 21 to 39 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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5 participants in 2 patient groups, including a placebo group

DHEA active treatment

Experimental group

Description:

Dehydroepiandrosterone 25 mg tid po

Treatment:

Dietary Supplement: Dehydroepiandrosterone

DHEA Placebo

Placebo Comparator group

Description:

Blinded placebo

Treatment:

Dietary Supplement: Placebo