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

Primary Purpose

Primary Ovarian Insufficiency, Unexplained Infertility

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dehydroepiandrosterone
Placebo
Sponsored by
Center for Human Reproduction
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Ovarian Insufficiency focused on measuring DHEA, Pregnancy

Eligibility Criteria

21 Years - 37 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Center for Human Reproduction

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DHEA

Placebo

Arm Description

Dehydroepiandrosterone (DHEA) administered at a dose of 25 mg tid po. DHEA is a weak androgen produced naturally by the adrenal in men and women. DHEA production is diminished with increasing age. Peak levels of DHEA occur in the late teenage years.

Blinded placebo

Outcomes

Primary Outcome Measures

Live Birth

Secondary Outcome Measures

Endocrine effects
Androgen side effects
Clinical Pregnancy

Full Information

First Posted
March 31, 2008
Last Updated
September 28, 2015
Sponsor
Center for Human Reproduction
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1. Study Identification

Unique Protocol Identification Number
NCT00650754
Brief Title
Study of Oral Dehydroepiandrosterone(DHEA) to Treat Previously Unexplained Infertility
Acronym
DHEAFert
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).
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
Failure to recruit designed nuimebrt of subjects
Study Start Date
March 2008 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center for Human Reproduction

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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: Informed consent Baseline studies Antral follicle counts on Day 2 - 3 of cycle Day 3 Serum FSH, LH, E2, Prog, DHEA, DHEAS, testosterone, AMH, Fragile X Randomization for pretreatment Group A: DHEA (25 mg three times per day) Group B: Placebo 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Ovarian Insufficiency, Unexplained Infertility
Keywords
DHEA, Pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DHEA
Arm Type
Experimental
Arm Description
Dehydroepiandrosterone (DHEA) administered at a dose of 25 mg tid po. DHEA is a weak androgen produced naturally by the adrenal in men and women. DHEA production is diminished with increasing age. Peak levels of DHEA occur in the late teenage years.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Blinded placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Dehydroepiandrosterone
Other Intervention Name(s)
DHEA
Intervention Description
25 mg PO TID
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Live Birth
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Endocrine effects
Time Frame
12 months
Title
Androgen side effects
Time Frame
12 months
Title
Clinical Pregnancy
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Barad, MD, MS
Organizational Affiliation
Center for Human Reproduction
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Norbert Gleicher, MD
Organizational Affiliation
Center for Human Reproduction
Official's Role
Study Chair
Facility Information:
Facility Name
Center for Human Reproduction
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.centerforhumanreprod.com/
Description
Center for Human Reproduction

Learn more about this trial

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

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