Infertility, FemalePhase 2/3DHEANCT04066478
Does DHEA IVF Outcomes in Poor Responders?
A Phase 2/3 study testing Dehydroepiandrosterone in people with Infertility, Female and Poor Response to Ovulation Induction, run by Homerton University Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study is a RCT to examine whether DHEA is capable of improving results for poor responders to ovarian stimulation during IVF treatment Read more about this study
- Who is it for?
- Ages 40 to 42 years, women only
- Conditions the study is for
- Infertility, Female, Poor Response to Ovulation Induction
- What is being tested?
- Dehydroepiandrosterone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Oct 2017to 31 Dec 2022
- 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 40 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age ≥ 40 years
- Markers for poor ovarian reserve (AMH <7 pmol/L(<1.1 ng/ml) and/or AFC< 7)
- Previous poor response to ovarian stimulation ( ≤3 oocytes with a conventional stimulation protocol)
Who cannot join
- Women > 42 years
- Women with premature ovarian failure / premature menopause (FSH>40 U/L). Women already taking DHEA.
- Patients with a known allergy to the trial drug or any of the active ingredients in the placebo.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Dehydroepiandrosterone (DHEA) Improve IVF Outcomes in Poor Responders? A Randomised, Double-blind, Placebo Controlled Trial
This study is a RCT to examine whether DHEA is capable of improving results for poor responders to ovarian stimulation during IVF treatment
Read the detailed description
Poor responders to ovarian stimulation for IVF may be either predicted or evidenced from previous treatment. The ESHRE criteria for poor responders will be used to select candidates for this trial. A power calculation determined that 200 subjects should be recruited to each arm to receive either DHEA or placebo.
- Being tested
- Dehydroepiandrosterone, Placebo
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DehydroepiandrosteroneDrug
75mg Dehydroepiandrosterone daily
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Teatment | Experimental | 75mg Dehydroepiandrosterone once daily for minimum ten weeks prior to starting ovarian stimulation Receives: Drug: Dehydroepiandrosterone |
| Comaprator | Placebo comparator | 75mg placebo once daily for minimum ten weeks prior to starting ovarian stimulation Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rates
ultrasound confirmation of a foetus with a heartbeat
Measured: at 6-8 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start8 Oct 2017
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Why it stopped: Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies 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
- Parallel groups
- Model description
- Randomised, double-blind, placebo controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Homerton University Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04066478
- Sponsor's protocol ID
- 2017DHEA
- Acronym
- DHEA
- Status last verified
- Jun 2022
- First submitted
- 22 Aug 2019
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Dehydroepiandrosterone (DHEA) Improve IVF Outcomes in Poor Responders? A Randomised, Double-blind, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT04066478
- Acronym / sponsor ID
- DHEA / 2017DHEA
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Sponsor
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Homerton University Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- 8 Oct 2017 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 26 Aug 2019 (actual)
- 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.
This study is a RCT to examine whether DHEA is capable of improving results for poor responders to ovarian stimulation during IVF treatment
Detailed description
Poor responders to ovarian stimulation for IVF may be either predicted or evidenced from previous treatment. The ESHRE criteria for poor responders will be used to select candidates for this trial. A power calculation determined that 200 subjects should be recruited to each arm to receive either DHEA or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomised, double-blind, placebo controlled study
| Arm | Type | Receives |
|---|---|---|
| Teatment | Experimental | Drug: Dehydroepiandrosterone75mg Dehydroepiandrosterone once daily for minimum ten weeks prior to starting ovarian stimulation |
| Comaprator | Placebo comparator | Drug: Placebo75mg placebo once daily for minimum ten weeks prior to starting ovarian stimulation |
Who may qualify
- Ages
- 40 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age ≥ 40 years
- Markers for poor ovarian reserve (AMH <7 pmol/L(<1.1 ng/ml) and/or AFC< 7)
- Previous poor response to ovarian stimulation ( ≤3 oocytes with a conventional stimulation protocol)
Key exclusion criteria (3 listed)
- Women > 42 years
- Women with premature ovarian failure / premature menopause (FSH>40 U/L). Women already taking DHEA.
- Patients with a known allergy to the trial drug or any of the active ingredients in the placebo.
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 |
|---|---|---|
| Dehydroepiandrosterone75mg Dehydroepiandrosterone daily | Drug | Teatment |
| PlaceboPlacebo | Drug | Comaprator |
Primary outcome
Clinical pregnancy rates
Time frame: at 6-8 weeks gestation
ultrasound confirmation of a foetus with a heartbeat
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Infertility, Female and Poor Response to Ovulation Induction, run by Homerton University Hospital NHS Foundation Trust at 1 site in United Kingdom.
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 3 inclusion and 3 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: paused, as of the sponsor's last update on 23 Jun 2022. 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 Kingdom. 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?
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?
Clinical pregnancy rates (time frame: at 6-8 weeks gestation). 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 23 Jun 2022.