Condition category
Pregnancy and Childbirth
Date applied
16/03/2005
Date assigned
01/09/2005
Last edited
30/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Siladitya Bhattacharya

ORCID ID

Contact details

Dept. of Obstetrics & Gynaecology
Aberdeen Maternity Hospital
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
+44 (0)1224 553267
s.bhattacharya@abdn.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CZH/4/17

Study information

Scientific title

Acronym

SUIT

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Infertility

Intervention

Clomifene citrate versus intrauterine insemination versus expectant management.

Intervention type

Drug

Phase

Not Specified

Drug names

Clomifene citrate

Primary outcome measures

To compare the three treatments in terms of efficacy, patient acceptability and costs.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2001

Overall trial end date

31/08/2006

Reason abandoned

Eligibility

Participant inclusion criteria

570 couples with unexplained infertility. Those with infertility of less than 2 years or females aged above 38 years will be excluded.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

570

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/09/2001

Recruitment end date

31/08/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Individual Sponsor (UK)

Sponsor details

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

Sponsor type

Not defined

Website

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18687718
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21127355

Publication citations

  1. Results

    Bhattacharya S, Harrild K, Mollison J, Wordsworth S, Tay C, Harrold A, McQueen D, Lyall H, Johnston L, Burrage J, Grossett S, Walton H, Lynch J, Johnstone A, Kini S, Raja A, Templeton A, Clomifene citrate or unstimulated intrauterine insemination compared with expectant management for unexplained infertility: pragmatic randomised controlled trial., BMJ, 2008, 337, a716.

  2. Results

    Wordsworth S, Buchanan J, Mollison J, Harrild K, Robertson L, Tay C, Harrold A, McQueen D, Lyall H, Johnston L, Burrage J, Grossett S, Walton H, Lynch J, Johnstone A, Kini S, Raja A, Templeton A, Bhattacharya S, Clomifene citrate and intrauterine insemination as first-line treatments for unexplained infertility: are they cost-effective?, Hum. Reprod., 2011, 26, 2, 369-375, doi: 10.1093/humrep/deq315.

Additional files

Editorial Notes