Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
19/02/2014
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 Ramasamy Chandra

ORCID ID

Contact details

Epsom and St. Helier NHS Trust
Women's Health
St Helier Hospital
Wrythe Lane
Carshalton
SM5 1AA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0112128478

Study information

Scientific title

Acronym

Study hypothesis

Clomid plus metamorformin is a better treatment option than Clomid alone for subfertility associated with polycystic ovarian syndrome.

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

Not Specified

Patient information sheet

Condition

Nutritional, Metabolic, Endocrine: PolyCystic Ovarian Syndrome (PCOS)

Intervention

Women will be randomised in blocks of six into two groups. One group will receive Clomid plus Metformin and the second group will receive Clomid alone.

Intervention type

Drug

Phase

Not Specified

Drug names

clomid versus clomid plus metformin

Primary outcome measures

Pregnancy.

Secondary outcome measures

1. Ovulation
2. Level of luteinising hormone
3. Level of testosterone
4. Body Mass Index.

Overall trial start date

01/11/2003

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Subfertile women attending St Helier hospital fertility clinic with problem of anovulation associated with polycystic ovarian syndrome.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/11/2003

Recruitment end date

31/12/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Epsom and St. Helier NHS Trust
Carshalton
SM5 1AA
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Epsom and St Helier University Hospitals NHS Trust (UK)

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

Publication citations

Additional files

Editorial Notes