Dehydroepiandrosterone (DHEA) Treatment and Premature Ovarian Failure (POF) — DHEAFert2  

Premature Ovarian Failure Clinical Trial

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

Status Terminated

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.

Clinical Trial 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 ;

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

• NCT number: NCT00948857
• Study type: Interventional
• Source: Center for Human Reproduction
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: June 2009
• Completion date: October 2011