premature ovarian failure, premature menopause, early menopausepremature ovarian failure, premature menopause, early menopause

premature ovarian failure, premature menopause, early menopause

 

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

premature ovarian failure, premature menopause, early menopause

 

This study is currently recruiting participants.

Purpose: 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.

Verified by: the Center for Human Reproduction
Sponsored by: Center for Human Reproduction
Clinicaltrials.gov identifier: NCT00948857

 

Condition Intervention Phase
Premature Ovarian Failure

 Dietary Supplement: Dehydroepiandrosterone
Dietary Supplement: Placebo

 Phase II
Phase III

 

Interested Volunteer Participants
Individuals who wish to participate in this study should fill out a POF application. Please note, all applicants will be reviewed by the committee to ensure that all approved participants meet the specified study criteria and guidelines.


 

STUDY DETAILS


Study Type: Interventional
Study Design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Official Title: A Randomized Double Blinded Trail of DHEA Supplementation for Treatment of Couples With Premature Ovarian Failure (POF).

Further study details as provided by Center for Human Reproduction:

Primary Outcome Measures
  • Live Birth [ Time Frame: 24 months ] [ Designated as safety issue: No ]


Secondary Outcome Measures
  • Endocrine effects [ Time Frame: 12 months ] [ Designated as safety issue: No ]

  • Androgen side effects [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

  • Clinical Pregnancy [ Time Frame: 12 months ] [ Designated as safety issue: No ]


Estimated Enrollment:240
Study Start Date: June 2009
Estimated Study Completion Date:March 2013
Estimated Primary Completion Date: March 2012
(Final data collection date for primary outcome measure)

Arms Assigned Interventions
A: Experimental
Dehydroepiandrosterone 25 mg tid po
Dietary Supplement: Dehydroepiandrosterone
25 mg PO TID
B: Placebo Comparator
Blinded placebo
Dietary Supplement: Placebo
Blinded 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 pretreatment
    • Compare antral follicle counts across pretreatment 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.
    • Allowing 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
Ages Eligible for Study: 21 Years to 45 Years
Genders Eligible for Study:Female

Accepts Healthy Volunteers:Yes

 

Criteria


Inclusion criteria:

  • >= 1 year of infertility
  • < 45 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

 

Location

United States, New York
Center for Human Reproduction  
New York, New York, United States, 10021
Principal Investigator: David Barad, MD, MS            
Sub-Investigator: Norbert Gleicher, MD            
           
Sponsors and Collaborators
Center for Human Reproduction
Principal Investigator: David Barad, MD, MS Center for Human Reproduction
Study Chair: Norbert Gleicher, MD Center for Human Reproduction


Responsible Party:Center for Human Reproduction ( Dr. David H. Barad )
Study ID Numbers:092508-01
First Received:July 28, 2009
Last Updated:July 28, 2009

ClinicalTrials.gov Identifier:NCT00948857

Health Authority:United States: Institutional Review Board

Keywords provided by Center for Human Reproduction:
DHEA
POF
Pregnancy


Additional relevant MeSH terms:

Genital Diseases, Female
Immunologic Factors
Gonadal Disorders
Physiological Effects of Drugs
Adjuvants, Immunologic
Dehydroepiandrosterone


Interested Volunteer Participants
Individuals who wish to participate in this study should fill out and submit an application. Please note, all applicants will be reviewed by the committee to ensure that all approved participants meet the specified study criteria and guidelines.