InfertilityPhase 3DITTONCT01572025
Dehydroepiandrosterone (DHEA) Intervention To Treat Ovarian Aging
A Phase 3 study testing Dehydroepiandrosterone in people with Infertility and Ovarian Aging, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
To test the hypothesis that supplementation of DHEA for at least twelve weeks prior to and during ovarian stimulation increases oocyte quantity (number of oocytes retrieved) and oocyte quality (clinical pregnancy rates and molecular markers) following IVF and IVF/ICSI treatment. Read more about this study
- Who is it for?
- Ages 23 to 48 years, women only
- Conditions the study is for
- Infertility, Ovarian Aging, Diminished Ovarian Reserve (DOR)
- What is being tested?
- Dehydroepiandrosterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2012to Dec 2014
- Phase
- Phase 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 23 to 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged above 23 years with diminished ovarian reserve (predicted to be poor-responder), defined as antral follicle count <10 and/or Anti-Mullerian hormone <5pmol/L
- Women undergoing IVF and IVF/ICSI treatment
- Women must have a regular spontaneous menstrual cycle of 21 - 35 days
Who cannot join
- Women with BMI >35 Kg/M2
- Women with a single ovary
- Women with untreated hydrosalpinx/ submucous fibroid/ endometrial polyp at the start of treatment
- Women with any history of seizure disorders
- Women with previous participation in this trial in an earlier treatment cycle
- Women with any known endocrine disorders such as congenital adrenal hyperplasia, thyroid diseases, hyperprolactinemia
- Known allergy to DHEA
- Diabetic women on insulin as insulin lowers DHEA levels and might reduce the effectiveness of DHEA supplements.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham University Research and Treatment Unit in Reproduction (NURTURE)
Nottingham, Nottinghamshire, NG7 2UH
About this study
Official title: Efficacy of Dehydroepiandrosterone to Overcome the Effect of Ovarian Aging - A Pilot Double Blinded Randomised Controlled Trial
- To test the hypothesis that supplementation of DHEA for at least twelve weeks prior to and during ovarian stimulation increases oocyte quantity (number of oocytes retrieved) and oocyte quality (clinical pregnancy rates and molecular markers) following IVF and IVF/ICSI treatment.
- To evaluate the feasibility of conducting a large multicentre trial
Read the detailed description
The purpose of this study is to evaluate the role of DHEA in counteracting the effects of ovarian ageing in an in-vitro fertilization (IVF) model. The study will examine whether the use of DHEA could improve clinical pregnancy rates following IVF treatment in women predicted to have aged ovaries by increasing oocyte quantity (ovarian response to gonadotrophins) and/ or by improving oocyte quality. The oocyte quality will be assessed by morphological and molecular markers.
This study will provide a mechanistic framework for translational research on mechanisms of ovarian ageing and drug interventions to slow down the ovarian ageing process and subsequent adverse physical and psychological consequences. Further, the data that will be produced from this research will have the potential to influence clinical practice in fertility clinics worldwide.
- Being tested
- Dehydroepiandrosterone, Placebo
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DehydroepiandrosteroneDrug
Dehydroepiandrosterone (DHEA)(St Mary's Pharmaceutical Unit Cardiff and Vale) DHEA 75 mg capsule. 1 capsule taken once daily for at least 12 weeks prior commencing ovarian stimulation protocol
: Stimulation protocol standard long down-regulation protocol, using human menopausal gonadotropin (HMG)
PlaceboDrug
Matched Placebo containing no active ingredient. 1 capsule taken once daily for at least 12 weeks prior commencing ovarian stimulation protocol
: Stimulation protocol standard long down-regulation protocol, using human menopausal gonadotropin (HMG)
| Study group | Role | What they receive |
|---|---|---|
| DHEA supplementation | Experimental | Not described Receives: Drug: Dehydroepiandrosterone |
| Control | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of oocytes retrieved
Oocytes retrieved within 15 weeks after DHEA/placebo supplementations.
Measured: within 15 weeks after DHEA/Placebo supplementation
Feasibility to conduct a large multicentre randomised controlled trial
Feasibility is evaluated by assessing recruitment rates and compliance of the recruited participants with DHEA/ placebo intake and follow up rates
Measured: with in 20 weeks of the research period (per participant)
Secondary outcomes (2)
Oocyte quality (clinical and molecular markers)
Clinical pregnancy rates (Pregnancy rate determined at week 5 to 7 after embryo transfer).
Molecular markers of oocyte quality as assessed by expression of cumulus cell molecular markers of oocyte competence and also by assessing energy consumption (pyruvate, lactate and glucose utilization) from the media by the oocytes and embryos (nutritional finger printing)
Measured: The sample is collected at 14-16 weeks after recruitment and assessment is performed at one year.
Aneuploidy rates in the immature oocytes and unfertilized oocytes using microarray technology
Measured: The sample is collected at 14-16 weeks after recruitment and assessment is performed at one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kannamannadiar Jayaprakasan, MRCOG,PhD., Principal investigator, Division of Obstetrics and Gynaecology, School of Clinical Sciences, University of NottinghamBruce Campbell, PhD, DSc, Study director, University of NottinghamNick Raine-Fenning, MRCOG, PhD, Study director, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01572025
- Sponsor's protocol ID
- 11054
- Other IDs
- 2011-002425-21
- Acronym
- DITTO
- Status last verified
- Dec 2015
- First submitted
- 19 Mar 2012
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jayaprakasan K, Narkwichean A, Maalouf WE, Campbell BK. Efficacy of dehydroepiandrosterone to overcome the effect of ovarian ageing (DITTO): a proof of principle randomised controlled trial protocol. BMJ Open. 2014 Oct 8;4(10):e005767. doi: 10.1136/bmjopen-2014-005767.
PubMed 25296654
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dehydroepiandrosterone to Overcome the Effect of Ovarian Aging - A Pilot Double Blinded Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01572025
- Acronym / sponsor ID
- DITTO / 11054
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 5 Apr 2012 (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.
- To test the hypothesis that supplementation of DHEA for at least twelve weeks prior to and during ovarian stimulation increases oocyte quantity (number of oocytes retrieved) and oocyte quality (clinical pregnancy rates and molecular markers) following IVF and IVF/ICSI treatment.
- To evaluate the feasibility of conducting a large multicentre trial
Detailed description
The purpose of this study is to evaluate the role of DHEA in counteracting the effects of ovarian ageing in an in-vitro fertilization (IVF) model. The study will examine whether the use of DHEA could improve clinical pregnancy rates following IVF treatment in women predicted to have aged ovaries by increasing oocyte quantity (ovarian response to gonadotrophins) and/ or by improving oocyte quality. The oocyte quality will be assessed by morphological and molecular markers.
This study will provide a mechanistic framework for translational research on mechanisms of ovarian ageing and drug interventions to slow down the ovarian ageing process and subsequent adverse physical and psychological consequences. Further, the data that will be produced from this research will have the potential to influence clinical practice in fertility clinics worldwide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DHEA supplementation | Experimental | Drug: Dehydroepiandrosterone |
| Control | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 23 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women aged above 23 years with diminished ovarian reserve (predicted to be poor-responder), defined as antral follicle count <10 and/or Anti-Mullerian hormone <5pmol/L
- Women undergoing IVF and IVF/ICSI treatment
- Women must have a regular spontaneous menstrual cycle of 21 - 35 days
Key exclusion criteria (8 listed)
- Women with BMI >35 Kg/M2
- Women with a single ovary
- Women with untreated hydrosalpinx/ submucous fibroid/ endometrial polyp at the start of treatment
- Women with any history of seizure disorders
- Women with previous participation in this trial in an earlier treatment cycle
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 |
|---|---|---|
| DehydroepiandrosteroneDehydroepiandrosterone (DHEA)(St Mary's Pharmaceutical Unit Cardiff and Vale) DHEA 75 mg capsule. 1 capsule taken once daily for at least 12 weeks prior commencing ovarian stimulation protocol : Stimulation protocol standard long down-regulation protocol, using human menopausal gonadotropin (HMG) | Drug | DHEA supplementation |
| PlaceboMatched Placebo containing no active ingredient. 1 capsule taken once daily for at least 12 weeks prior commencing ovarian stimulation protocol : Stimulation protocol standard long down-regulation protocol, using human menopausal gonadotropin (HMG) | Drug | Control |
Primary outcome
Number of oocytes retrieved
Time frame: within 15 weeks after DHEA/Placebo supplementation
Oocytes retrieved within 15 weeks after DHEA/placebo supplementations.
Feasibility to conduct a large multicentre randomised controlled trial
Time frame: with in 20 weeks of the research period (per participant)
Feasibility is evaluated by assessing recruitment rates and compliance of the recruited participants with DHEA/ placebo intake and follow up rates
2 secondary outcomes
Oocyte quality (clinical and molecular markers)
Time frame: The sample is collected at 14-16 weeks after recruitment and assessment is performed at one year.
Aneuploidy rates in the immature oocytes and unfertilized oocytes using microarray technology
Time frame: The sample is collected at 14-16 weeks after recruitment and assessment is performed at one year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
- Derived from this study: PubMed 25296654Jayaprakasan K, Narkwichean A, Maalouf WE, Campbell BK. Efficacy of dehydroepiandrosterone to overcome the effect of ovarian ageing (DITTO): a proof of principle randomised controlled trial protocol. BMJ Open. 2014 Oct 8;4(10):e005767. doi: 10.1136/bmjopen-2014-005767.
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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.
Kannamannadiar Jayaprakasan, MRCOG,PhD. principal investigator
Division of Obstetrics and Gynaecology, School of Clinical Sciences, University of Nottingham
Bruce Campbell, PhD, DSc study director
University of Nottingham
Nick Raine-Fenning, MRCOG, PhD study director
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dehydroepiandrosterone in people with Infertility and Ovarian Aging, run by University of Nottingham 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 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: finished, as of the sponsor's last update on 9 Dec 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 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 phase mean?
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of oocytes retrieved (time frame: within 15 weeks after DHEA/Placebo supplementation). 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?
On the ClinicalTrials.gov record for NCT01572025, which also lists 1 linked publication.
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 9 Dec 2015.