PregnancyNCT00683202
Low-Dose Aspirin in in Vitro Fertilization (IVF) and Intracytoplasmic Sperm Injection (ICSI) Treatments
A study testing Acetylsalicylic acid in people with Pregnancy and Miscarriage Less Than 12 Gestational Weeks, run by University of Oulu at 1 site in Finland.
Trial summary
In this study we hypothesized that low-dose aspirin therapy (100 mg daily) improves ovarian responsiveness, uterine haemodynamics and clinical pregnancy rates in unselected subjects undergoing IVF/ICSI when the treatment is started concomitantly with controlled ovarian hyperstimulation. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Pregnancy, Miscarriage Less Than 12 Gestational Weeks, Extrauterine Pregnancy
- What is being tested?
- Acetylsalicylic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 374 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2001to Mar 2006
- 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 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- age < 40 years
- < 4 previous ovarian stimulations
Who cannot join
- allergy for acetylsalicylic acid
Trial locations and contacts
1 site in 1 country.
Finland1 site
University Hospital of Oulu, Department of Obstetrics and Gynecology
Oulu, 90220
About this study
Official title: The Significance of Low-Dose Aspirin on Ovarian Responsiveness, Uterine Hemodynamics and Pregnancy Outcome in in Vitro Fertilization and in Intracytoplasmic Sperm Injection: A Randomized, Placebo-Controlled Double-Blind Study
In this study we hypothesized that low-dose aspirin therapy (100 mg daily) improves ovarian responsiveness, uterine haemodynamics and clinical pregnancy rates in unselected subjects undergoing IVF/ICSI when the treatment is started concomitantly with controlled ovarian hyperstimulation.
Read the detailed description
Low-dose acetylsalicylic acid irreversibly inhibits the cyclo-oxygenase enzyme in platelets, thus preventing the synthesis of thromboxane, which causes vasoconstriction and platelet aggregation. By this mechanism low-dose aspirin may enhance ovarian and uterine blood flow and tissue perfusion and thus improve ovarian responsiveness for gonadotrophins and endometrial receptivity for implantation. Randomized controlled studies and meta-analyses on the low-dose aspirin therapy to improve IVF/ICSI outcome or uterine hemodynamics have revealed conflicting results.
- Conditions
- Pregnancy, Miscarriage Less Than 12 Gestational Weeks, Extrauterine Pregnancy, Preeclampsia, Intrauterine Fetal Growth Restriction
- Being tested
- Acetylsalicylic acid, Placebo
- Keywords
- Assisted reproduction, Ovarian response, Uteroplacental hemodynamics, Doppler ultrasonography, Implantation rate, Pregnancy rate, Live birth rate
- Medical subject headings
- Pregnancy, Ectopic, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylsalicylic acidDrug
Also called Low-dose aspirin
Acetylsalicylic acid 100 mg or placebo daily perorally started on the first day of ovarian gonadotrophin stimulation in in vitro fertilization or in intracytoplasmic sperm injection
PlaceboDrug
Acetylsalicylic acid 100 mg or placebo daily perorally started on the first day of ovarian gonadotrophin stimulation in in vitro fertilization or in intracytoplasmic sperm injection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Acetylsalicylic acid 100 mg daily perorally Receives: Drug: Acetylsalicylic acid |
| 2 | Placebo comparator | Placebo daily perorally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
Measured: Five weeks after embryo transfer
Secondary outcomes (1)
Uterine artery and spiral artery pulsatility index values
Measured: On the day of embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2008 (estimated)
- Study startMar 2001
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 374 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer, Kuopio University Hospital, Tampere University
- Investigators
- Mervi Haapsamo, MD, Principal investigator, University Hospital of Oulu, FinlandJuha Rasanen, MD, Study director, University Hospital of Oulu, Finland and Oregon Health Sciences University, Oregon USAHannu Martikainen, MD, Study director, University Hospital of Oulu, FinlandJuha S Tapanainen, Prof, Study director, University Hospital of Oulu, FinlandSeppo Heinonen, Prof, Study director, University Hospital of Kuopio, FinlandHelena Tinkanen, MD, Study director, Unversity Hospital of Tampere, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00683202
- Sponsor's protocol ID
- 56/2001
- Status last verified
- Mar 2001
- First submitted
- 21 May 2008
- Last updated
- 23 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Haapsamo M, Martikainen H, Tinkanen H, Heinonen S, Nuojua-Huttunen S, Rasanen J. Low-dose aspirin therapy and hypertensive pregnancy complications in unselected IVF and ICSI patients: a randomized, placebo-controlled, double-blind study. Hum Reprod. 2010 Dec;25(12):2972-7. doi: 10.1093/humrep/deq286. Epub 2010 Oct 13.
PubMed 20943705Haapsamo M, Martikainen H, Rasanen J. Low-dose aspirin and uterine haemodynamics on the day of embryo transfer in women undergoing IVF/ICSI: a randomized, placebo-controlled, double-blind study. Hum Reprod. 2009 Apr;24(4):861-6. doi: 10.1093/humrep/den489. Epub 2009 Jan 18.
PubMed 19153091
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Significance of Low-Dose Aspirin on Ovarian Responsiveness, Uterine Hemodynamics and Pregnancy Outcome in in Vitro Fertilization and in Intracytoplasmic Sperm Injection: A Randomized, Placebo-Controlled Double-Blind Study
- ClinicalTrials.gov ID
- NCT00683202
- Acronym / sponsor ID
- 56/2001
- Conditions
- Pregnancy, Miscarriage Less Than 12 Gestational Weeks, Extrauterine Pregnancy, Preeclampsia, Intrauterine Fetal Growth Restriction
- Keywords
- Assisted reproduction, Ovarian response, Uteroplacental hemodynamics, Doppler ultrasonography, Implantation rate, Pregnancy rate, Live birth rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 374 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Bayer, Kuopio University Hospital, Tampere University
- Study start
- Mar 2001
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 23 May 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.
In this study we hypothesized that low-dose aspirin therapy (100 mg daily) improves ovarian responsiveness, uterine haemodynamics and clinical pregnancy rates in unselected subjects undergoing IVF/ICSI when the treatment is started concomitantly with controlled ovarian hyperstimulation.
Detailed description
Low-dose acetylsalicylic acid irreversibly inhibits the cyclo-oxygenase enzyme in platelets, thus preventing the synthesis of thromboxane, which causes vasoconstriction and platelet aggregation. By this mechanism low-dose aspirin may enhance ovarian and uterine blood flow and tissue perfusion and thus improve ovarian responsiveness for gonadotrophins and endometrial receptivity for implantation. Randomized controlled studies and meta-analyses on the low-dose aspirin therapy to improve IVF/ICSI outcome or uterine hemodynamics have revealed conflicting results.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Acetylsalicylic acidAcetylsalicylic acid 100 mg daily perorally |
| 2 | Placebo comparator | Drug: PlaceboPlacebo daily perorally |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age < 40 years
- < 4 previous ovarian stimulations
Key exclusion criteria (1 listed)
- allergy for acetylsalicylic acid
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 |
|---|---|---|
| Acetylsalicylic acidAlso: Low-dose aspirinAcetylsalicylic acid 100 mg or placebo daily perorally started on the first day of ovarian gonadotrophin stimulation in in vitro fertilization or in intracytoplasmic sperm injection | Drug | 1 |
| PlaceboAcetylsalicylic acid 100 mg or placebo daily perorally started on the first day of ovarian gonadotrophin stimulation in in vitro fertilization or in intracytoplasmic sperm injection | Drug | 2 |
Primary outcome
Pregnancy rate
Time frame: Five weeks after embryo transfer
1 secondary outcome
Uterine artery and spiral artery pulsatility index values
Time frame: On the day of embryo transfer
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 23 May 2008.
- Derived from this study: PubMed 20943705Haapsamo M, Martikainen H, Tinkanen H, Heinonen S, Nuojua-Huttunen S, Rasanen J. Low-dose aspirin therapy and hypertensive pregnancy complications in unselected IVF and ICSI patients: a randomized, placebo-controlled, double-blind study. Hum Reprod. 2010 Dec;25(12):2972-7. doi: 10.1093/humrep/deq286. Epub 2010 Oct 13.
- Derived from this study: PubMed 19153091Haapsamo M, Martikainen H, Rasanen J. Low-dose aspirin and uterine haemodynamics on the day of embryo transfer in women undergoing IVF/ICSI: a randomized, placebo-controlled, double-blind study. Hum Reprod. 2009 Apr;24(4):861-6. doi: 10.1093/humrep/den489. Epub 2009 Jan 18.
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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.
Mervi Haapsamo, MD principal investigator
University Hospital of Oulu, Finland
Juha Rasanen, MD study director
University Hospital of Oulu, Finland and Oregon Health Sciences University, Oregon USA
Hannu Martikainen, MD study director
University Hospital of Oulu, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetylsalicylic acid in people with Pregnancy and Miscarriage Less Than 12 Gestational Weeks, run by University of Oulu at 1 site in Finland.
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 1 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 23 May 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 Finland. 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.
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?
Pregnancy rate (time frame: Five weeks after embryo transfer). 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 NCT00683202, which also lists 2 linked publications.
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 May 2008.