Clinical trial NCT00948857: Dehydroepiandrosterone (DHEA) Treatment and Premature Ovarian Failure (POF)
Official title: A Randomized Double Blinded Trail of DHEA Supplementation for Treatment of Couples With Premature Ovarian Failure (POF).
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Premature Ovarian Failure
Keywords: DHEA
POF
Pregnancy
Ovarian Failure
Otherwise Unexplained infertility
Ovarian aging
Lead sponsor: Center for Human Reproduction
Sponsor class: OTHER
First posted: 2009-07-29
Enrollment: 5
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Live Birth
timeFrame: 24 months
measure: Live Birth
timeFrame: 9 months
Secondary outcomes:
measure: Endocrine Effects
timeFrame: 12 months
measure: Androgen Side Effects
timeFrame: 12 months
measure: Clinical Pregnancy
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Center for Human Reproduction
state: New York
Study officials:
affiliation: Center for Human Reproduction
name: David Barad, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Human Reproduction
name: Norbert Gleicher, MD
role: STUDY_CHAIR
References: