Ovarian StimulationNCT01145144
Dehydroepiandrosterone Supplementation for Poor Responder Patients During in Vitro Fertilization Treatment
A study testing dehydroepiandrosterone crystalline fine powder in people with Ovarian Stimulation, run by Meir Medical Center at 2 sites in Israel.
Trial summary
The aim of this study was to evaluate the effect of dehydroepiandrosterone supplementation on in vitro fertilization performance and outcome among poor-responder patient. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Ovarian Stimulation
- What is being tested?
- dehydroepiandrosterone crystalline fine powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 2 sitesIsrael
- Study dates
- Jan 2008to Jul 2009
- Phase
- Interventional
- 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 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- previous poor response to ovarian stimulation in IVF.
Who cannot join
- patients over the age of 42
- patients who received DHEA at any time.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Meir Medical center IVF unit
Kfar Saba, Kfar Saba
Meir Medical Center
Kfar Saba, Kfar Sava
About this study
The aim of this study was to evaluate the effect of dehydroepiandrosterone supplementation on in vitro fertilization performance and outcome among poor-responder patient.
- Conditions
- Ovarian Stimulation
- Being tested
- dehydroepiandrosterone crystalline fine powder
- Keywords
- Dehydroepiandrosterone, DHEA, IVF outcome, long protocol IVF, poor-responder, recombinant LH, embryo quality, pregnancy rate, live birth rate, poor response to ovarian stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dehydroepiandrosterone crystalline fine powderDrug
| Study group | Role | What they receive |
|---|---|---|
| DHEA supplementation | Experimental | DHEA was added to induction of ovulation by recombinant FSH and recombinant LH, in IVF long protocol Receives: Drug: dehydroepiandrosterone crystalline fine powder |
| only induction of ovulation by same long protocol without DHEA | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak estradiol level.
number of retrieved oocytes.
Embryos that were graded as a top quality (according to the number of cells and percent of fragmentation)
number of embryos reserved for transfer.
Secondary outcomes (2)
pregnancy rate.
live birth rate.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2010 (estimated)
- Study startJan 2008
- Primary completionJul 2009
- Study completionJul 2009
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 Ovarian StimulationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01145144
- Sponsor's protocol ID
- mmc07204-2006ctil
- Status last verified
- Jun 2010
- First submitted
- 3 May 2010
- Last updated
- 16 Jun 2010
- Results posted
- No
Publications
Wiser A, Gonen O, Ghetler Y, Shavit T, Berkovitz A, Shulman A. Addition of dehydroepiandrosterone (DHEA) for poor-responder patients before and during IVF treatment improves the pregnancy rate: a randomized prospective study. Hum Reprod. 2010 Oct;25(10):2496-500. doi: 10.1093/humrep/deq220. Epub 2010 Aug 21.
PubMed 20729538
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dehydroepiandrosterone Supplementation for Poor Responder Patients During in Vitro Fertilization Treatment
- ClinicalTrials.gov ID
- NCT01145144
- Acronym / sponsor ID
- mmc07204-2006ctil
- Conditions
- Ovarian Stimulation
- Keywords
- Dehydroepiandrosterone, DHEA, IVF outcome, long protocol IVF, poor-responder, recombinant LH, embryo quality, pregnancy rate
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 16 Jun 2010 (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 aim of this study was to evaluate the effect of dehydroepiandrosterone supplementation on in vitro fertilization performance and outcome among poor-responder patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DHEA supplementation | Experimental | Drug: dehydroepiandrosterone crystalline fine powderDHEA was added to induction of ovulation by recombinant FSH and recombinant LH, in IVF long protocol |
| only induction of ovulation by same long protocol without DHEA | No intervention | – |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- previous poor response to ovarian stimulation in IVF.
Key exclusion criteria (2 listed)
- patients over the age of 42
- patients who received DHEA at any time.
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 |
|---|---|---|
| dehydroepiandrosterone crystalline fine powder | Drug | DHEA supplementation |
Primary outcome
peak estradiol level.
number of retrieved oocytes.
Embryos that were graded as a top quality (according to the number of cells and percent of fragmentation)
number of embryos reserved for transfer.
2 secondary outcomes
pregnancy rate.
live birth rate.
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 16 Jun 2010.
- Derived from this study: PubMed 20729538Wiser A, Gonen O, Ghetler Y, Shavit T, Berkovitz A, Shulman A. Addition of dehydroepiandrosterone (DHEA) for poor-responder patients before and during IVF treatment improves the pregnancy rate: a randomized prospective study. Hum Reprod. 2010 Oct;25(10):2496-500. doi: 10.1093/humrep/deq220. Epub 2010 Aug 21.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dehydroepiandrosterone crystalline fine powder in people with Ovarian Stimulation, run by Meir Medical Center at 2 sites in Israel.
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 1 inclusion and 2 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 16 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
peak estradiol level.. The study lists 4 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 NCT01145144, 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 16 Jun 2010.