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

Primary Purpose

Infertility

Status

Completed

Phase

Phase 3

Locations

Belgium

Study Type

Interventional

Intervention

aspirin

placebo

Sponsored by

University Hospital, Ghent

About this trial

This is an interventional treatment trial for Infertility focused on measuring IVF and ICSI

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

University Hospital Ghent

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

oral administration of aspirin 100 mg

oral administration of placebo

Outcomes

Primary Outcome Measures

Number of oocytes retrieved

Clinical pregnancy rate per embryo transfer

Secondary Outcome Measures

Live birth rate per cycle

Full Information

NCT ID

First Posted

March 20, 2008

Last Updated

March 26, 2008

Sponsor

University Hospital, Ghent

1. Study Identification

Unique Protocol Identification Number

NCT00644085

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2008

Overall Recruitment Status

Completed

Study Start Date

April 2000 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Ghent

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

Keywords

IVF and ICSI

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

201 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1

Arm Type

Experimental

Arm Description

oral administration of aspirin 100 mg

Arm Title

2

Arm Type

Placebo Comparator

Arm Description

oral administration of placebo

Intervention Type

Drug

Intervention Name(s)

aspirin

Intervention Description

oral administration of aspirin 100 mg

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

oral administration of placebo

Primary Outcome Measure Information:

Title

Number of oocytes retrieved

Title

Clinical pregnancy rate per embryo transfer

Secondary Outcome Measure Information:

Title

Live birth rate per cycle

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marc Dhont, MD, PhD

Organizational Affiliation

University Hospital, Ghent

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Ghent

City

Ghent

ZIP/Postal Code

9000

Country

Belgium

12. IPD Sharing Statement

Citations:

PubMed Identifier

19131401

Citation

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.

Results Reference

derived

Links:

URL

http://www.uzgent.be

Description

Related Info

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

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