infertility trialsinfertility

infertility

 

Study of Oral Dehydroepiandrosterone(DHEA) to Treat Previously Unexplained Infertility

 

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 otherwise unexplained infertility and evidence of premature ovarian aging (POA).

Verified by: the Center for Human Reproduction
Sponsored by: Center for Human Reproduction
Clinicaltrials.gov identifier: NCT00650754

 

Condition Intervention Phase
Ovarian Aging
Premature Ovarian Aging
Unexplained Infertility
 Dietary Supplement: Dehydroepiandrosterone
 Phase II
Phase III

 

Interested Volunteer Participants
Individuals who wish to participate in this study should fill out a DHEA 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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Safety/Efficacy Study
Official Title: A Randomized Double Blinded Trail of DHEA Supplementation for Treatment of Couples With Normal Hysterosalpingogram and Normal Semen Analysis and Evidence of Premature Ovarian Aging (POA).

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:220
Study Start Date: March 2008
Estimated Study Completion Date:March 2010
Estimated Primary Completion Date: March 2009
(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: Dehydroepiandrosterone
25 mg PO TID

Detailed Description

Recruitment:Eligible patients will be recruited by advertising on the web and in newspaper. We will screen women under 38 years old with regular menstrual cycles and more than one year of infertility.

Experimental plan

  1. Informed consent
  2. Baseline studies
    • Antral follicle counts on Day 2 - 3 of cycle
    • Day 3 Serum FSH, LH, E2, Prog, DHEA, DHEAS, testosterone, AMH, Fragile X
  3. Randomization for pretreatment
    • 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
    • Pregnancy rate for unexplained infertility is 2% per cycle.
    • Intervention will improve pregnancy rate to 5% per cycle.
    • Patients will be treated for 8 cycles.
    • Cumulative pregnancy rate for control patients - 13%
    • Cumulative pregnancy rate for Treated patients - 30%
    • Require 91 patients to complete treatment in each group.
    • Allow for 20% dropout ( 91* 1.2) will need 109 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 8 months and possible natural continued loss of fertility
  • Informed consent issues

    •  

Eligibility
Ages Eligible for Study: 21 Years to 37 Years
Genders Eligible for Study:Female

Accepts Healthy Volunteers:Yes

 

Criteria


Inclusion criteria:

  • >= 1 year of infertility
  • < 38 years old
  • Normal HSG
  • Normal Semen analysis (Count >= 20 million/ motility > 50%/ Kruger morph > 14%.
  • Regular menses
  • Willingness to sign informed consent for study randomization
  • Willingness to participate in 8 months of non-IVF will he him treatment.

Exclusion criteria:

  • Abnormal semen analysis
  • Abnormal HSG
  • Baseline FSH/E2 within normal age specific criteria
  • 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 eight 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            
Sub-Investigator: Kutluk Oktay, 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:CHR2008 1.0
First Received:March 31, 2008
Last Updated:October 15, 2008

ClinicalTrials.gov Identifier:NCT00650754

Health Authority:United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Center for Human Reproduction:
DHEA
Pregnancy

Study placed in the following topic categories:
Genital Diseases, Female
Infertility
Dehydroepiandrosterone
Genital Diseases, Male

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Pharmacologic Actions


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.