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Low-Dose Aspirin in in Vitro Fertilization (IVF) and Intracytoplasmic Sperm Injection (ICSI) Treatments

This study has been completed.
Kuopio University Hospital
University of Tampere
Information provided by:
University of Oulu Identifier:
First received: May 21, 2008
Last updated: May 22, 2008
Last verified: March 2001
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
Miscarriage Less Than 12 Gestational Weeks
Extrauterine Pregnancy
Intrauterine Fetal Growth Restriction
Drug: Acetylsalicylic acid
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Uterine artery and spiral artery pulsatility index values [ Time Frame: On the day of embryo transfer ]

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.

Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age < 40 years
  • < 4 previous ovarian stimulations

Exclusion Criteria:

  • allergy for acetylsalicylic acid
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Please refer to this study by its identifier: NCT00683202

University Hospital of Oulu, Department of Obstetrics and Gynecology
Oulu, Finland, 90220
Sponsors and Collaborators
University of Oulu
Kuopio University Hospital
University of Tampere
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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Mervi Haapsamo/MD, University Hospital of Oulu Identifier: NCT00683202     History of Changes
Other Study ID Numbers: 56/2001
Study First Received: May 21, 2008
Last Updated: May 22, 2008

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:
Pregnancy, Ectopic
Hypertension, Pregnancy-Induced
Pregnancy Complications
Abortion, Spontaneous
Fetal Growth Retardation
Fetal Diseases
Growth Disorders
Pathologic Processes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics processed this record on May 25, 2017