Premature Ovarian FailurePhase 2/3DHEAFert2NCT00948857
Dehydroepiandrosterone (DHEA) Treatment and Premature Ovarian Failure (POF)
A Phase 2/3 study testing Dehydroepiandrosterone in people with Premature Ovarian Failure, run by David H. Barad at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Ovarian Failure
- What is being tested?
- Dehydroepiandrosterone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Oct 2011
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- >= 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Human Reproduction
New York, New York, 10021
About this study
Official title: A Randomized Double Blinded Trail of DHEA Supplementation for Treatment of Couples With Premature Ovarian Failure (POF).
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.
Read the detailed description
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
- Conditions
- Premature Ovarian Failure
- Being tested
- Dehydroepiandrosterone, Placebo
- Keywords
- DHEA, POF, Pregnancy, Ovarian Failure, Otherwise Unexplained infertility, Ovarian aging
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DehydroepiandrosteroneDietary supplement
Also called DHEA
25 mg PO TID
PlaceboDietary supplement
Blinded placebo
| Study group | Role | What they receive |
|---|---|---|
| DHEA active treatment | Experimental | Dehydroepiandrosterone 25 mg tid po Receives: Dietary Supplement: Dehydroepiandrosterone |
| DHEA Placebo | Placebo comparator | Blinded placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live Birth
Measured: 24 months
Live Birth
Live Birth outcome compared between DHEA active treatment and Placebo
Measured: 9 months
Secondary outcomes (3)
Endocrine Effects
Measured: 12 months
Androgen Side Effects
Measured: 12 months
Clinical Pregnancy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionOct 2011
- Study completionOct 2011
Why it stopped: Lack of recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Premature Ovarian FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- David H. Barad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David H. Barad, Center for Human Reproduction
- Investigators
- David Barad, MD, MS, Principal investigator, Center for Human ReproductionNorbert Gleicher, MD, Study chair, Center for Human Reproduction
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00948857
- Sponsor's protocol ID
- 092508-01
- Acronym
- DHEAFert2
- Status last verified
- Sep 2012
- First submitted
- 28 Jul 2009
- Last updated
- 10 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double Blinded Trail of DHEA Supplementation for Treatment of Couples With Premature Ovarian Failure (POF).
- ClinicalTrials.gov ID
- NCT00948857
- Acronym / sponsor ID
- DHEAFert2 / 092508-01
- Conditions
- Premature Ovarian Failure
- Keywords
- DHEA, POF, Pregnancy, Ovarian Failure, Otherwise Unexplained infertility, Ovarian aging
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- David H. BaradUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 29 Jul 2009 (estimated)
- Results
- Posted 5 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DHEA active treatment | Experimental | Dietary Supplement: DehydroepiandrosteroneDehydroepiandrosterone 25 mg tid po |
| DHEA Placebo | Placebo comparator | Dietary Supplement: PlaceboBlinded placebo |
Who may qualify
- Ages
- 21 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- >= 1 year of infertility
- >21 and <40 years old
- Normal HSG
- Normal Semen analysis (Count >= 20 million/ motility > 50%/ Kruger morph > 14%.
- Absent menses
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DehydroepiandrosteroneAlso: DHEA25 mg PO TID | Dietary supplement | DHEA active treatment |
| PlaceboBlinded placebo | Dietary supplement | DHEA Placebo |
Primary outcome
Live Birth
Time frame: 24 months
Live Birth
Time frame: 9 months
Live Birth outcome compared between DHEA active treatment and Placebo
3 secondary outcomes
Endocrine Effects
Time frame: 12 months
Androgen Side Effects
Time frame: 12 months
Clinical Pregnancy
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Premature Ovarian Failure
RecruitingPhase 2
Autologous Hair Follicle-Derived Secretome and Platelet-Rich Plasma for Premature Ovarian Insufficiency
Premature Ovarian Insufficiency, POI
RecruitingObservational study
Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
Turner Syndrome, Post-menarcheal Adolescents
Not yet recruitingPhase 1
Oral GDC-0077 in Premature Ovarian Insufficiency
Primary Ovarian Insufficiency
RecruitingPhase 3
Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency
Premature Ovarian Insufficiency
RecruitingObservational study
Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires
Systemic Lupus Erythematosus (Sle), Primary Ovarian Insufficiency (Poi)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Barad, MD, MS principal investigator
Center for Human Reproduction
Norbert Gleicher, MD study chair
Center for Human Reproduction
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dehydroepiandrosterone in people with Premature Ovarian Failure, run by David H. Barad at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live Birth (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2012.