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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00650754
Other study ID # CHR2008 1.0
Secondary ID
Status Terminated
Phase Phase 2/Phase 3
First received March 31, 2008
Last updated September 28, 2015
Start date March 2008
Est. completion date March 2014

Study information

Verified date September 2015
Source Center for Human Reproduction
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial 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).


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:

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


Recruitment information / eligibility

Status Terminated
Enrollment 35
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 21 Years to 37 Years
Eligibility 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 Design

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


Intervention

Dietary Supplement:
Dehydroepiandrosterone
25 mg PO TID
Other:
Placebo
Placebo

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Center for Human Reproduction

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Live Birth 24 months No
Secondary Endocrine effects 12 months No
Secondary Androgen side effects 12 months Yes
Secondary Clinical Pregnancy 12 months No
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