InfertilityPhase 3NCT00644085
Does Low-Dose Aspirin Improve Outcome in In Vitro Fertilisation/Intra Cytoplasmatic Sperm Injection (IVF/ICSI)?
A Phase 3 study testing aspirin in people with Infertility, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
To investigate the effect of daily administration of low-dose aspirin, compared to placebo, on IVF and ICSI outcome. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Infertility
- What is being tested?
- aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2000to Dec 2007
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Dutch-speaking women
- Starting a first or second IVF/ICSI cycle
Who cannot join
- Women suffering from
- platelet dysfunction
- thrombopenia
- gastro-intestinal ulcers
- recurrent gastritis
- aspirin hypersensitivity
- Women on treatment with anticoagulants or aspirin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Low-Dose Aspirin Improve Outcome in IVF/ICSI? A Prospective, Randomized, Double Blind Placebo Controlled Trial
To investigate the effect of daily administration of low-dose aspirin, compared to placebo, on IVF and ICSI outcome.
- Conditions
- Infertility
- Being tested
- aspirin, placebo
- Keywords
- IVF and ICSI
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspirinDrug
oral administration of aspirin 100 mg
placeboDrug
oral administration of placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | oral administration of aspirin 100 mg Receives: Drug: aspirin |
| 2 | Placebo comparator | oral administration of placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of oocytes retrieved
Clinical pregnancy rate per embryo transfer
Secondary outcomes (1)
Live birth rate per cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startApr 2000
- Study completionDec 2007
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.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Investigators
- Marc Dhont, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644085
- Sponsor's protocol ID
- 99/191
- Status last verified
- Mar 2008
- First submitted
- 20 Mar 2008
- Last updated
- 28 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Dirckx K, Cabri P, Merien A, Galajdova L, Gerris J, Dhont M, De Sutter P. Does low-dose aspirin improve pregnancy rate in IVF/ICSI? A randomized double-blind placebo controlled trial. Hum Reprod. 2009 Apr;24(4):856-60. doi: 10.1093/humrep/den476. Epub 2009 Jan 8.
PubMed 19131401
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Low-Dose Aspirin Improve Outcome in IVF/ICSI? A Prospective, Randomized, Double Blind Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT00644085
- Acronym / sponsor ID
- 99/191
- Conditions
- Infertility
- Keywords
- IVF and ICSI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Apr 2000
- Study completion
- Dec 2007 (actual)
- First posted
- 26 Mar 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.
To investigate the effect of daily administration of low-dose aspirin, compared to placebo, on IVF and ICSI outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: aspirinoral administration of aspirin 100 mg |
| 2 | Placebo comparator | Drug: placebooral administration of placebo |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Dutch-speaking women
- Starting a first or second IVF/ICSI cycle
Key exclusion criteria (7 listed)
- Women suffering from
- Women on treatment with anticoagulants or aspirin
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 |
|---|---|---|
| aspirinoral administration of aspirin 100 mg | Drug | 1 |
| placebooral administration of placebo | Drug | 2 |
Primary outcome
Number of oocytes retrieved
Clinical pregnancy rate per embryo transfer
1 secondary outcome
Live birth rate per cycle
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 28 Mar 2008.
- Derived from this study: PubMed 19131401Dirckx K, Cabri P, Merien A, Galajdova L, Gerris J, Dhont M, De Sutter P. Does low-dose aspirin improve pregnancy rate in IVF/ICSI? A randomized double-blind placebo controlled trial. Hum Reprod. 2009 Apr;24(4):856-60. doi: 10.1093/humrep/den476. Epub 2009 Jan 8.
- Related InfoLink provided by the sponsor.
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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.
Marc Dhont, MD, PhD principal investigator
University Hospital, Ghent
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 aspirin in people with Infertility, run by University Hospital, Ghent at 1 site in Belgium.
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 2 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: finished, as of the sponsor's last update on 28 Mar 2008. 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 Belgium. 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. 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 NCT00644085, 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 28 Mar 2008.