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

A Randomized Double Blinded Trail of DHEA Supplementation for Treatment of Couples With Premature Ovarian Failure (POF).

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.

Study Overview

• Status: Terminated
• Conditions: Premature Ovarian Failure
• Intervention / Treatment: Dietary supplement: Dehydroepiandrosterone; Dietary supplement: Placebo

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

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Center for Human Reproduction

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DHEA active treatment; Dehydroepiandrosterone 25 mg tid po	Dietary supplement: Dehydroepiandrosterone; 25 mg PO TID; Other Names: DHEA
Placebo Comparator: DHEA Placebo; Blinded placebo	Dietary supplement: Placebo; Blinded placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Live Birth		24 months
Live Birth	Live Birth outcome compared between DHEA active treatment and Placebo	9 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Endocrine Effects	12 months
Androgen Side Effects	12 months
Clinical Pregnancy	12 months

Collaborators and Investigators

• Sponsor: David H. Barad
• Investigators: Study Chair: Norbert Gleicher, MD, Center for Human Reproduction; Principal Investigator: David Barad, MD, MS, Center for Human Reproduction

Publications and helpful links

Helpful Links

• Center for Human Reproduction

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: July 28, 2009
• First Submitted That Met QC Criteria: July 28, 2009
• First Posted (Estimate): July 29, 2009

Study Record Updates

• Last Update Posted (Estimate): September 10, 2012
• Last Update Submitted That Met QC Criteria: September 4, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Pregnancy; DHEA; Ovarian Failure; POF; Otherwise Unexplained infertility; Ovarian aging
• Additional Relevant MeSH Terms: Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Primary Ovarian Insufficiency; Menopause, Premature; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Dehydroepiandrosterone
• Other Study ID Numbers: 092508-01