The effectiveness of intrauterine insemination (IUI) in subfertile couples with an isolated cervical factor: a randomised controlled trial
| ISRCTN | ISRCTN63217062 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63217062 |
| Protocol serial number | 2 |
| Sponsor | Academic Medical Center Amsterdam (The Netherlands) |
| Funder | The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) |
- Submission date
- 08/02/2006
- Registration date
- 08/02/2006
- Last edited
- 19/10/2007
- 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
Mrs P Steures
Scientific
Scientific
Academic Medical Center
Center of Reproductive Medicine
OFO-project
H4-213
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 5663857 |
|---|---|
| ofoproject@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre, randomised, active controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 1. We hypothesised a beneficial effect of IUI in couples with an isolated cervical factor 2. Furthermore we hypothesised that the post-coital test can identify those couples who would benefit from IUI without ovarian hyperstimulation |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Subfertility |
| Intervention | Couples were randomly allocated to IUI for six months or expectant management for six months. In the first three IUI cycles no controlled ovarian hyperstimulation (COH) was given. If these attempts failed subsequent IUI cycles were performed with COH. Couples allocated to expectant management were followed until an ongoing pregnancy occurred within six months. If no pregnancy occurred, follow-up ended after this period. If a pregnancy miscarried, follow-up continued until the next pregnancy or the end of the six months period. |
| Intervention type | Other |
| Primary outcome measure(s) |
The primary endpoint was ongoing pregnancy within six months. Ongoing pregnancy was defined as the presence of foetal cardiac activity at transvaginal sonography at a gestational age of at least 12 weeks. |
| Key secondary outcome measure(s) |
Secondary endpoints were total number of clinical pregnancies, miscarriages and multiple pregnancies. |
| Completion date | 01/07/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 100 |
| Key inclusion criteria | Couples with a cervical factor and otherwise no factors that reduced their fertility i.e. a prognosis for a treatment independent ongoing pregnancy in the next year higher than 30%. A cervical factor was diagnosed by a well-timed, non-progressive post-coital test (PCT) with normal semen parameters. |
| Key exclusion criteria | All other subfertile couples |
| Date of first enrolment | 01/06/2002 |
| Date of final enrolment | 01/07/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center
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 | 01/12/2007 | Yes | No |
