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Does Low-Dose Aspirin Improve Outcome in In Vitro Fertilisation/Intra Cytoplasmatic Sperm Injection (IVF/ICSI)?

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00644085
First received: March 20, 2008
Last updated: March 26, 2008
Last verified: March 2008
History of Changes
  Purpose

To investigate the effect of daily administration of low-dose aspirin, compared to placebo, on IVF and ICSI outcome.


Condition Intervention Phase
Infertility
 Drug: aspirin
Drug: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Does Low-Dose Aspirin Improve Outcome in IVF/ICSI? A Prospective, Randomized, Double Blind Placebo Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Infertility
Drug Information available for: Aspirin
U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Number of oocytes retrieved [ Designated as safety issue: No ]
  • Clinical pregnancy rate per embryo transfer [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Live birth rate per cycle [ Designated as safety issue: No ]

Enrollment: 201
Study Start Date: April 2000
Study Completion Date: December 2007
Arms Assigned Interventions
Experimental: 1
oral administration of aspirin 100 mg
 Drug: aspirin
oral administration of aspirin 100 mg
Placebo Comparator: 2
oral administration of placebo
 Drug: placebo
oral administration of placebo

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Dutch-speaking women
  • Starting a first or second IVF/ICSI cycle

Exclusion Criteria:

  • Women suffering from

    • platelet dysfunction
    • thrombopenia
    • gastro-intestinal ulcers
    • recurrent gastritis
    • aspirin hypersensitivity
  • Women on treatment with anticoagulants or aspirin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00644085

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Marc Dhont, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided by University Hospital, Ghent

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kaatje Dirckx, MD, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00644085     History of Changes
Other Study ID Numbers: 99/191
Study First Received: March 20, 2008
Last Updated: March 26, 2008
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital, Ghent:
IVF and ICSI

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
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 May 22, 2013