Effectiveness of intrauterine insemination with ovarian hyperstimulation in couples with an unexplained moderately reduced fertility
| ISRCTN | ISRCTN72675518 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72675518 |
| Secondary identifying numbers | 1 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- 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)20 566 3857 |
|---|---|
| ofoproject@amc.uva.nl |
Study information
| Study design | Multicentre, randomised, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | There is no additional benefit of Intrauterine Insemination (IUI) with Controlled Ovarian Hyperstimulation (COH) over expectant management for 6 months in couples with unexplained subfertility and a chance of a spontaneous pregnancy between 30% and 40%. Categorisation of unexplained subfertile couples by their prognosis can identify those couples who benefit from IUI with COH and those who do not. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Unexplained Subfertility |
| Intervention | After informed consent had been given, couples were randomly allocated between IUI with COH and expectant management for six months. Couples allocated to IUI with COH started treatment in the next cycle. Controlled ovarian hyper stimulation as well as semen preparation and insemination regimens were performed according to hospital-specific protocols. Couples allocated to expectant management were followed until an ongoing pregnancy occurred within six months, these pregnancies were finally followed until birth. 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 | 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. |
| Secondary outcome measures | Secondary endpoints were total number of clinical pregnancies, miscarriages and multiple pregnancies. |
| Overall study start date | 01/06/2002 |
| Completion date | 01/07/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 250 |
| Key inclusion criteria | All subfertile couples in whom no reason is found during the basic fertility work-up for their subfertility and in whom their spontaneous pregnancy chance in the next year, calculated by the results of the basic fertility work-up, is between 30% and 40%. |
| Key exclusion criteria | All couples in whom a reason is found for their subfertility or who are having another prognosis calculated |
| 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
Sponsor information
Academic Medical Centre (AMC) (Netherlands)
University/education
University/education
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Website | http://www.amc.uva.nl/ |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 15/07/2006 | Yes | No |
