Primary Ovarian InsufficiencyPhase 2/3DHEAFertNCT00650754
Study of Oral Dehydroepiandrosterone(DHEA) to Treat Previously Unexplained Infertility
A Phase 2/3 study testing Dehydroepiandrosterone in people with Primary Ovarian Insufficiency and Unexplained Infertility, run by Center for Human Reproduction 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 otherwise unexplained infertility and evidence of premature ovarian aging (POA). Read more about this study
- Who is it for?
- Ages 21 to 37 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Ovarian Insufficiency, Unexplained Infertility
- What is being tested?
- Dehydroepiandrosterone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Mar 2014
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 37 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- >= 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.
Who cannot join
- 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
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 Normal Hysterosalpingogram and Normal Semen Analysis and Evidence of Premature Ovarian Aging (POA).
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).
Read the detailed 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:
- Informed consent
- Baseline studies
- Antral follicle counts on Day 2 - 3 of cycle
- Day 3 Serum FSH, LH, E2, Prog, DHEA, DHEAS, testosterone, AMH, Fragile X
- Randomization for pretreatment
- 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 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
- Being tested
- Dehydroepiandrosterone, Placebo
- Keywords
- DHEA, Pregnancy
- 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
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| DHEA | Experimental | Dehydroepiandrosterone (DHEA) administered at a dose of 25 mg tid po. DHEA is a weak androgen produced naturally by the adrenal in men and women. DHEA production is diminished with increasing age. Peak levels of DHEA occur in the late teenage years. Receives: Dietary Supplement: Dehydroepiandrosterone |
| Placebo | Placebo comparator | Blinded placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live Birth
Measured: 24 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 posted2 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: Failure to recruit designed nuimebrt of subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Ovarian InsufficiencyStudies 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Human Reproduction
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- 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
- NCT00650754
- Sponsor's protocol ID
- CHR2008 1.0
- Acronym
- DHEAFert
- Status last verified
- Sep 2015
- First submitted
- 31 Mar 2008
- Last updated
- 30 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2015. 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 Normal Hysterosalpingogram and Normal Semen Analysis and Evidence of Premature Ovarian Aging (POA).
- ClinicalTrials.gov ID
- NCT00650754
- Acronym / sponsor ID
- DHEAFert / CHR2008 1.0
- Keywords
- DHEA, Pregnancy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failure to recruit designed nuimebrt of subjects
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Center for Human ReproductionUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 2 Apr 2008 (estimated)
- Results
- Not posted in the source record
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 otherwise unexplained infertility and evidence of premature ovarian aging (POA).
Detailed 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:
- Informed consent
- Baseline studies
- Antral follicle counts on Day 2 - 3 of cycle
- Day 3 Serum FSH, LH, E2, Prog, DHEA, DHEAS, testosterone, AMH, Fragile X
- Randomization for pretreatment
- 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 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
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 | Experimental | Dietary Supplement: DehydroepiandrosteroneDehydroepiandrosterone (DHEA) administered at a dose of 25 mg tid po. DHEA is a weak androgen produced naturally by the adrenal in men and women. DHEA production is diminished with increasing age. Peak levels of DHEA occur in the late teenage years. |
| Placebo | Placebo comparator | Other: PlaceboBlinded placebo |
Who may qualify
- Ages
- 21 to 37 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- >= 1 year of infertility
- < 38 years old
- Normal HSG
- Normal Semen analysis (Count >= 20 million/ motility > 50%/ Kruger morph > 14%.
- Regular menses
Key exclusion criteria (8 listed)
- 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
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 |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Live Birth
Time frame: 24 months
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
The study was stopped early (reason given: Failure to recruit designed nuimebrt of subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2015.
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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 Primary Ovarian Insufficiency and Unexplained Infertility, run by Center for Human Reproduction 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 8 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 30 Sep 2015. 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?
The study was stopped early (reason given: Failure to recruit designed nuimebrt of subjects). Results are not available in the source record.
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). 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 30 Sep 2015.