Expired Study
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New York, New York 10021


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).


Study summary:

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


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


Study is Available At:


Original ID:

CHR2008 1.0


NCT ID:

NCT00650754


Secondary ID:


Study Acronym:

DHEAFert


Brief Title:

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


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).


Overall Status:

Terminated


Study Phase:

Phase 2/Phase 3


Genders:

Female


Minimum Age:

21 Years


Maximum Age:

37 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Center for Human Reproduction


Oversight Authority:

  • United States: Institutional Review Board
  • United States: Food and Drug Administration


Reasons Why Stopped:

Failure to recruit designed nuimebrt of subj


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

35


Enrollment Type:

Actual


Overall Contact Information

Official Name:David Barad, MD, MS
Principal Investigator
Center for Human Reproduction

Study Dates

Start Date:March 2008
Completion Date:March 2014
Completion Type:Actual
Primary Completion Date:March 2014
Primary Completion Type:Actual
Verification Date:September 2015
Last Changed Date:September 28, 2015
First Received Date:March 31, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Clinical Pregnancy
Time Frame:12 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Androgen side effects
Time Frame:12 months
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Endocrine effects
Time Frame:12 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Live Birth
Time Frame:24 months
Safety Issues:False

Study Interventions

Intervention Type:Dietary Supplement
Name:Dehydroepiandrosterone
Description:25 mg PO TID
Arm Name:DHEA
Other Name:DHEA
Intervention Type:Other
Name:Placebo
Description:Placebo
Arm Name:Placebo
Other Name:Placebo

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:Blinded placebo
Study Arm Type:Experimental
Arm Name:DHEA
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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Center for Human Reproduction

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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