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
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
-
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.