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

This study has been completed.
Sponsor:
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
  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 April 17, 2014