ISRCTN ISRCTN97507474
DOI https://doi.org/10.1186/ISRCTN97507474
Secondary identifying numbers NTR610
Submission date
04/04/2006
Registration date
04/04/2006
Last edited
26/08/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr P.G.A. Hompes
Scientific

VU University Medical Center
Department of Obstetrics and Gynaecology
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Phone +31 (0)20 4444444
Email p.hompes@vumc.nl

Study information

Study designProspective randomised double blind placebo controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleAdded 26/08/09: Low dose aspirin in IVF. A prospective, randomised, double blind placebo controlled trial.
Study objectivesBy 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(s)Received from local medical ethics committee
Health condition(s) or problem(s) studiedSubfertility
InterventionPatients undergo regular IVF/ICSI treatment combined with low dose aspirin or placebo.
Intervention typeOther
Primary outcome measureOngoing pregnancy rate
Secondary outcome measures1. Number of follicles
2. Number of oocytes retrieved
Overall study start date01/06/2002
Completion date01/08/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants150
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/06/2002
Date of final enrolment01/08/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

VU University Medical Center
Amsterdam
1007 MB
Netherlands

Sponsor information

VU University Medical Centre (VUMC) (Netherlands)
Hospital/treatment centre

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

ROR logo "ROR" https://ror.org/00q6h8f30

Funders

Funder type

Hospital/treatment centre

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2009 Yes No