Scottish Unexplained Infertility Trial: a randomised trial of clomiphene versus intrauterine insemination for unexplained infertility

ISRCTN	ISRCTN71762042
DOI	https://doi.org/10.1186/ISRCTN71762042
Secondary identifying numbers	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

Dept. of Obstetrics & Gynaecology
Aberdeen Maternity Hospital
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom

Phone	+44 (0)1224 553267
Email	s.bhattacharya@abdn.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Clomifene citrate
Primary outcome measure	To compare the three treatments in terms of efficacy, patient acceptability and costs.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/09/2001
Completion date	31/08/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	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

Scotland
United Kingdom

Study participating centre

Dept. of Obstetrics & Gynaecology

Aberdeen
AB25 2ZD
United Kingdom

Sponsor information

Individual Sponsor (UK)
Not defined

Mr. Fred Stevenson-Robb
Director, Research & Innovation
University of Aberdeen
University Office
King's College
Regent Walk
Old Aberdeen
Aberdeen
AB24 3FX
United Kingdom

Funders

Funder type

Government

Chief Scientist Office of the Scottish Executive Health Department (UK) (ref: CZH/4/17)

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	07/08/2008		Yes	No
Results article	results	01/02/2011		Yes	No