Scottish Unexplained Infertility Trial: a randomised trial of clomiphene versus intrauterine insemination for unexplained infertility
| ISRCTN | ISRCTN71762042 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71762042 |
| Protocol serial number | CZH/4/17 |
| Sponsor | Individual Sponsor (UK) |
| Funder | Chief Scientist Office of the Scottish Executive Health Department (UK) (ref: CZH/4/17) |
- Submission date
- 16/03/2005
- Registration date
- 01/09/2005
- Last edited
- 30/10/2012
- 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 Siladitya Bhattacharya
Scientific
Scientific
Dept. of Obstetrics & Gynaecology
Aberdeen Maternity Hospital
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
| Phone | +44 (0)1224 553267 |
|---|---|
| s.bhattacharya@abdn.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | SUIT |
| Study objectives | To assess the efficacy of clomiphene citrate versus intrauterine insemination (IUI) versus no treatment using the partner's semen sample in the treatment of unexplained infertility. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Infertility |
| Intervention | Clomifene citrate versus intrauterine insemination versus expectant management. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Clomifene citrate |
| Primary outcome measure(s) |
To compare the three treatments in terms of efficacy, patient acceptability and costs. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/08/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 570 |
| Key inclusion criteria | 570 couples with unexplained infertility. Those with infertility of less than 2 years or females aged above 38 years will be excluded. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/09/2001 |
| Date of final enrolment | 31/08/2006 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
Dept. of Obstetrics & Gynaecology
Aberdeen
AB25 2ZD
United Kingdom
AB25 2ZD
United Kingdom
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 | 07/08/2008 | Yes | No | |
| Results article | results | 01/02/2011 | Yes | No |
