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

NCT ID: NCT00644085

Last Updated: 2008-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-04-30

Study Completion Date

2007-12-31

Brief Summary

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

Detailed Description

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Conditions

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Infertility

Keywords

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IVF and ICSI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

oral administration of aspirin 100 mg

Group Type EXPERIMENTAL

aspirin

Intervention Type DRUG

oral administration of aspirin 100 mg

2

oral administration of placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

oral administration of placebo

Interventions

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aspirin

oral administration of aspirin 100 mg

Intervention Type DRUG

placebo

oral administration of placebo

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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University Hospital Ghent

Principal Investigators

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Marc Dhont, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

References

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Dirckx K, Cabri P, Merien A, Galajdova L, Gerris J, Dhont M, De Sutter P. Does low-dose aspirin improve pregnancy rate in IVF/ICSI? A randomized double-blind placebo controlled trial. Hum Reprod. 2009 Apr;24(4):856-60. doi: 10.1093/humrep/den476. Epub 2009 Jan 8.

Reference Type DERIVED
PMID: 19131401 (View on PubMed)

Related Links

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Other Identifiers

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99/191

Identifier Type: -

Identifier Source: org_study_id