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

March 26, 2008 updated by: University Hospital, Ghent

Does Low-Dose Aspirin Improve Outcome in IVF/ICSI? A Prospective, Randomized, Double Blind Placebo Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

201

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • University Hospital Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Number of oocytes retrieved
Clinical pregnancy rate per embryo transfer

Secondary Outcome Measures

Outcome Measure
Live birth rate per cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Marc Dhont, MD, PhD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2000

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

March 20, 2008

First Submitted That Met QC Criteria

March 25, 2008

First Posted (Estimate)

March 26, 2008

Study Record Updates

Last Update Posted (Estimate)

March 28, 2008

Last Update Submitted That Met QC Criteria

March 26, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 99/191

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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