Aspirin in in vitro fertilisation (IVF)
| ISRCTN | ISRCTN97507474 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97507474 |
| Protocol serial number | NTR610 |
| Sponsor | VU University Medical Centre (VUMC) (Netherlands) |
| Funder | VU University Medical Centre (VUMC) (Netherlands) - Department of Obstetrics and Gynaecology, Division of Reproductive Medicine |
- 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
Scientific
VU University Medical Center
Department of Obstetrics and Gynaecology
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
| Phone | +31 (0)20 4444444 |
|---|---|
| p.hompes@vumc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised double blind placebo controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Added 26/08/09: Low dose aspirin in IVF. A prospective, randomised, double blind placebo controlled trial. |
| Study objectives | 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(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Subfertility |
| Intervention | Patients undergo regular IVF/ICSI treatment combined with low dose aspirin or placebo. |
| Intervention type | Other |
| Primary outcome measure(s) |
Ongoing pregnancy rate |
| Key secondary outcome measure(s) |
1. Number of follicles |
| Completion date | 01/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 150 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2002 |
| Date of final enrolment | 01/08/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
VU University Medical Center
Amsterdam
1007 MB
Netherlands
1007 MB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
