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

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ClinicalTrials.gov Identifier: NCT00644085
Recruitment Status : Completed
First Posted : March 26, 2008
Last Update Posted : March 28, 2008
Sponsor:
Information provided by:
University Hospital, Ghent

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

Condition or disease Intervention/treatment Phase
Infertility Drug: aspirin Drug: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Does Low-Dose Aspirin Improve Outcome in IVF/ICSI? A Prospective, Randomized, Double Blind Placebo Controlled Trial
Study Start Date : April 2000
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Number of oocytes retrieved
  2. Clinical pregnancy rate per embryo transfer

Secondary Outcome Measures :
  1. Live birth rate per cycle


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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
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
First Posted: March 26, 2008    Key Record Dates
Last Update Posted: March 28, 2008
Last Verified: March 2008

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
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics