Low-Dose Aspirin in in Vitro Fertilization (IVF) and Intracytoplasmic Sperm Injection (ICSI) Treatments
This study has been completed.
Sponsor:
University of Oulu
Collaborators:
Bayer
Kuopio University Hospital
University of Tampere
Information provided by:
University of Oulu
ClinicalTrials.gov Identifier:
NCT00683202
First received: May 21, 2008
Last updated: May 22, 2008
Last verified: March 2001
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pregnancy Miscarriage Less Than 12 Gestational Weeks Extrauterine Pregnancy Preeclampsia Intrauterine Fetal Growth Restriction |
Drug: Acetylsalicylic acid Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| 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 |
Resource links provided by NLM:
Further study details as provided by University of Oulu:
Primary Outcome Measures:
- Pregnancy rate [ Time Frame: Five weeks after embryo transfer ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Uterine artery and spiral artery pulsatility index values [ Time Frame: On the day of embryo transfer ] [ Designated as safety issue: No ]
| Enrollment: | 374 |
| Study Start Date: | March 2001 |
| Study Completion Date: | March 2006 |
| Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Acetylsalicylic acid 100 mg daily perorally
|
Drug: Acetylsalicylic acid
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
Other Name: Low-dose aspirin
|
|
Placebo Comparator: 2
Placebo daily perorally
|
Drug: Placebo
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 39 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- age < 40 years
- < 4 previous ovarian stimulations
Exclusion Criteria:
- allergy for acetylsalicylic acid
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00683202
Locations
| Finland | |
| University Hospital of Oulu, Department of Obstetrics and Gynecology | |
| Oulu, Finland, 90220 | |
Sponsors and Collaborators
University of Oulu
Bayer
Kuopio University Hospital
University of Tampere
Investigators
| Principal Investigator: | Mervi Haapsamo, MD | University Hospital of Oulu, Finland |
| Study Director: | Juha Rasanen, MD | University Hospital of Oulu, Finland and Oregon Health Sciences University, Oregon USA |
| Study Director: | Hannu Martikainen, MD | University Hospital of Oulu, Finland |
| Study Director: | Juha S Tapanainen, Prof | University Hospital of Oulu, Finland |
| Study Director: | Seppo Heinonen, Prof | University Hospital of Kuopio, Finland |
| Study Director: | Helena Tinkanen, MD | Unversity Hospital of Tampere, Finland |
More Information
No publications provided by University of Oulu
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Mervi Haapsamo/MD, University Hospital of Oulu |
| ClinicalTrials.gov Identifier: | NCT00683202 History of Changes |
| Other Study ID Numbers: | 56/2001 |
| Study First Received: | May 21, 2008 |
| Last Updated: | May 22, 2008 |
| Health Authority: | Finland: Finnish Medicines Agency |
Keywords provided by University of Oulu:
|
Assisted reproduction Ovarian response Uteroplacental hemodynamics Doppler ultrasonography |
Implantation rate Pregnancy rate Live birth rate |
Additional relevant MeSH terms:
|
Abortion, Spontaneous Fetal Growth Retardation Pre-Eclampsia Pregnancy, Ectopic Pregnancy Complications Fetal Diseases Growth Disorders Pathologic Processes Hypertension, Pregnancy-Induced Aspirin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 17, 2013