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

Study Overview
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Brief Summary
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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.

Detailed Description
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Recruitment: New patients presenting for Donor egg cycles Possible print, magazine or Radio advertisement Experimental plan: Informed consent Baseline studies Antral follicle counts Serum FSH, LH, E2, Prog, DHEA, DHEAS, testosterone, AMH, Fragile X Randomization 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 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

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

Conditions
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Premature Ovarian Failure

Intervention / Treatment
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* Dietary Supplement: Dehydroepiandrosterone
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DHEA active treatment<br>Dehydroepiandrosterone 25 mg tid po | Dietary Supplement: Dehydroepiandrosterone<br>* 25 mg PO TID<br>* Other names: DHEA;|
| Placebo Comparator: DHEA Placebo<br>Blinded placebo | Dietary Supplement: Placebo<br>* Blinded placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live Birth |  | 24 months | 
| Live Birth | Live Birth outcome compared between DHEA active treatment and Placebo | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endocrine Effects |  | 12 months | 
| Androgen Side Effects |  | 12 months | 
| Clinical Pregnancy |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DHEA, POF, Pregnancy, Ovarian Failure, Otherwise Unexplained infertility, Ovarian aging