NCT00644085

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2000

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2000

Completed
7.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2008

Completed
Last Updated

March 28, 2008

Status Verified

March 1, 2008

First QC Date

March 20, 2008

Last Update Submit

March 26, 2008

Conditions

Infertility

Keywords

IVF and ICSI

Outcome Measures

Primary Outcomes (2)

  • Number of oocytes retrieved

  • Clinical pregnancy rate per embryo transfer

Secondary Outcomes (1)

  • Live birth rate per cycle

Study Arms (2)

1

EXPERIMENTAL

oral administration of aspirin 100 mg

Drug: aspirin

2

PLACEBO COMPARATOR

oral administration of placebo

Drug: placebo

Interventions

aspirinDRUG

oral administration of aspirin 100 mg

1
placeboDRUG

oral administration of placebo

2

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Women suffering from
  • platelet dysfunction
  • thrombopenia
  • gastro-intestinal ulcers
  • recurrent gastritis
  • aspirin hypersensitivity
  • Women on treatment with anticoagulants or aspirin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 19131401DERIVED

Related Links

MeSH Terms

Conditions

Infertility

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Marc Dhont, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 20, 2008

First Posted

March 26, 2008

Study Start

April 1, 2000

Study Completion

December 1, 2007

Last Updated

March 28, 2008

Record last verified: 2008-03

Locations

BE(1)