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

Premature Ovarian Failure Clinical Trial

— DHEAFert2  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00948857
• Other study ID #: 092508-01
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: July 28, 2009
• Last updated: September 4, 2012
• Start date: June 2009
• Est. completion date: October 2011

Study information

• Verified date: September 2012
• Source: Center for Human Reproduction
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 39 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Menopause, Premature
• Premature Birth
• Premature Ovarian Failure
• Primary Ovarian Insufficiency

Intervention

Dietary Supplement:
• Dehydroepiandrosterone
25 mg PO TID
• Placebo
Blinded placebo

Locations

Country	Name	City	State
United States	Center for Human Reproduction	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
David H. Barad

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live Birth		24 months	No
Primary	Live Birth	Live Birth outcome compared between DHEA active treatment and Placebo	9 months	No
Secondary	Endocrine Effects		12 months	No
Secondary	Androgen Side Effects		12 months	Yes
Secondary	Clinical Pregnancy		12 months	No

External Links

•   Center for Human Reproduction