Condition category
Urological and Genital Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
07/09/2015
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

Mr Richard Howell

ORCID ID

Contact details

Fertility Unit
Homerton University Hospital NHS Trust
Homerton Row
London
E9 6SR
United Kingdom
+44 (0)20 8510 7660
abc@email.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0024120995

Study information

Scientific title

The use of metformin in patients with polycystic ovarian syndrome requiring treatment with in vitro fertilisation (IVF)

Acronym

Study hypothesis

Metformin has been shown to be useful in patients with polycystic ovarian syndrome (PCOS) undergoing IVF. The aim of this study is to investigate whether metformin therapy in patients with polycystic ovaries can improve the fertilisation rates and significantly improve pregnancy rates.

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

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Urological and Genital Diseases: Polycystic ovarian syndrome (PCOS)

Intervention

Group A will be given 500 mg metformin TDS for 1 month prior to their treatment. Group B will not be treated with metformin. Both groups will undergo standard IVF treatment.

Intervention type

Drug

Phase

Not Applicable

Drug names

Metformin

Primary outcome measures

1. Total number of folicles reaching 18 mm
2. Number of eggs obtained, number and quality of mature eggs, fertilisation rates
3. Total number of embryos, number and quality of embryos replaced and number of embryos frozen
4. Biochemical pregnancies, clinical pregnancies
5. Number of cycles abandoned for poor response and over response
6. Number of cases of ovarian hyperstimulation in each group

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2003

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with PCOS

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

100

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/01/2003

Recruitment end date

31/12/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Homerton University Hospital NHS Trust
London
E9 6SR
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Homerton University Hospital NHS Trust

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