Randomised controlled trial of bed rest versus no bed rest after intra-uterine insemination: impact on pregnancy rates
| ISRCTN | ISRCTN53294431 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53294431 |
| Protocol serial number | NTR426 |
| Sponsor | Academic Medical Centre (AMC) (Netherlands) |
| Funder | Academic Medical Centre (AMC) (Netherlands) |
- Submission date
- 27/06/2007
- Registration date
- 27/06/2007
- Last edited
- 02/11/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr I. Custers
Scientific
Scientific
Academic Medical Centre (AMC)
Department of Obstetrics and Gynecology
Centre for Reproductive Medicine
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 566 4355 |
|---|---|
| i.m.custers@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled parallel group multicentre trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Does a short time of immobilisation (i.e., 15 minutes) after Intra-Uterine Insemination (IUI) have a potential advantage on pregnancy rates, compared to immediate mobilisation and does it outweigh the disadvantage of the extra time and working space it consumes? |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Subfertility |
| Intervention | Intra uterine insemination will be performed in spontaneous cycles as well in cycles with Controlled Ovarian Hyper-stimulation (IUI-COH). IUI will be performed in lithotomy position with Trendelenburg tilt. After the insemination has been performed, the patient will, according to their allocation, immediately stand up and go home, or will return to normal supine position, and remain so for 15 minutes. |
| Intervention type | Other |
| Primary outcome measure(s) |
Ongoing pregnancy |
| Key secondary outcome measure(s) |
Biochemical, clinical, ectopic pregnancy. |
| Completion date | 01/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 280 |
| Key inclusion criteria | All patients, receiving IUI with fresh or cryo-preserved donor- or husbands sperm IUI with or without Controlled Ovarian Hyper-stimulation (IUI-COH), as a treatment for their subfertility will be eligible for the trial. |
| Key exclusion criteria | 1. Tubal pathology of both fallopian tubes 2. Patients younger than 18 years or older than 43 years of age |
| Date of first enrolment | 01/09/2005 |
| Date of final enrolment | 01/09/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre (AMC)
Amsterdam
1100 DD
Netherlands
1100 DD
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 | 29/10/2009 | Yes | No |
