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ISRCTN
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ISRCTN97507474
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ClinicalTrials.gov identifier
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Public title
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Aspirin in in vitro fertilisation (IVF)
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Scientific title
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Added 26/08/09: Low dose aspirin in IVF. A prospective, randomised, double blind placebo controlled trial.
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Acronym
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N/A
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Serial number at source
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NTR610
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Received from local medical ethics committee
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Study design
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Prospective randomised double blind placebo controlled parallel group trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Subfertility
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/06/2002
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Anticipated end date
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01/08/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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150
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Interventions
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Patients undergo regular IVF/ICSI treatment combined with low dose aspirin or placebo.
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Primary outcome measure(s)
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Ongoing pregnancy rate
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Secondary outcome measure(s)
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1. Number of follicles
2. Number of oocytes retrieved
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Sources of funding
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VU University Medical Centre (VUMC) (Netherlands) - Department of Obstetrics and Gynaecology, Division of Reproductive Medicine
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Trial website
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Publications
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2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18973893
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Contact name
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Dr
P.G.A.
Hompes
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Address
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VU University Medical Center
Department of Obstetrics and Gynaecology
P.O. Box 7057
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City/town
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Amsterdam
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Zip/Postcode
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1007 MB
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Country
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Netherlands
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Tel
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+31 (0)20 4444444
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Email
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p.hompes@vumc.nl
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Sponsor
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VU University Medical Centre (VUMC) (Netherlands)
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Address
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Department of Obstetrics and Gynaecology,
Division of Reproductive Medicine
P.O. Box 7057
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City/town
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Amsterdam
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Zip/Postcode
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1007 MB
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Country
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Netherlands
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Date applied
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04/04/2006
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Last edited
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26/08/2009
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Date ISRCTN assigned
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04/04/2006
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