Condition category
Urological and Genital Diseases
Date applied
04/04/2006
Date assigned
04/04/2006
Last edited
26/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr P.G.A. Hompes

ORCID ID

Contact details

VU University Medical Center
Department of Obstetrics and Gynaecology
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
+31 (0)20 4444444
p.hompes@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR610

Study information

Scientific title

Added 26/08/09: Low dose aspirin in IVF. A prospective, randomised, double blind placebo controlled trial.

Acronym

Study hypothesis

By its pharmacological action it is likely that aspirin improves ovarian perfusion, uterine perfusion and reduces endometrial restraint on the implanting embryo. Therefore the hypothesis of this study is that the use of low dose aspirin in IVF improves pregnancy rates.

Ethics approval

Received from local medical ethics committee

Study design

Prospective randomised double blind placebo controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Subfertility

Intervention

Patients undergo regular IVF/ICSI treatment combined with low dose aspirin or placebo.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Ongoing pregnancy rate

Secondary outcome measures

1. Number of follicles
2. Number of oocytes retrieved

Overall trial start date

01/06/2002

Overall trial end date

01/08/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients undergoing IVF or intracytoplasmic sperm injection (ICSI) treatment
2. Age <39 years
3. Cycle day 3 follicle stimulating hormone (FSH) <10 IU/l
4. No contra-indications against the use of low-dose aspirin

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

150

Participant exclusion criteria

1. Systemic diseases
2. Hypertension
3. Previous allergic reaction to study medication
4. Previous ovarian hyperstimulation syndrome (OHSS)
5. Untreated endocrinopathies
6. Smoking >5 cigarettes/day
7. Body mass index (BMI) >28

Recruitment start date

01/06/2002

Recruitment end date

01/08/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

VU University Medical Center
Amsterdam
1007 MB
Netherlands

Sponsor information

Organisation

VU University Medical Centre (VUMC) (Netherlands)

Sponsor details

Department of Obstetrics and Gynaecology
Division of Reproductive Medicine
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

VU University Medical Centre (VUMC) (Netherlands) - Department of Obstetrics and Gynaecology, Division of Reproductive Medicine

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18973893

Publication citations

  1. Results

    Lambers MJ, Hoozemans DA, Schats R, Homburg R, Lambalk CB, Hompes PG, Low-dose aspirin in non-tubal IVF patients with previous failed conception: a prospective randomized double-blind placebo-controlled trial., Fertil. Steril., 2009, 92, 3, 923-929, doi: 10.1016/j.fertnstert.2008.07.1759.

Additional files

Editorial Notes