Condition category
Urological and Genital Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
29/04/2010
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 AH Balen

ORCID ID

Contact details

Obstetrics & Gynaecology
C Floor
Clarendon Wing
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom
+44 (0)113 392 2728
adam.balen@leedsth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436118094

Study information

Scientific title

Acronym

Study hypothesis

A prospective, randomised, double-blinded, placebo-controlled study using a short course of metformin treatment in patients with polycystic ovary syndrome or polycystic ovaries undergoing standard IVF treatment.

Ethics approval

Not provided at time of registration

Study design

Prospective randomised double-blinded placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Urological and Genital Diseases: Polycystic ovarian syndrome (PCOS)

Intervention

Laboratory study; Case-note review; Database analysis; Randomised controlled trial, Random allocation to:
A. Metformin alone
B. Metformin + low dose follicle-stimulating hormone (FSH)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Change in average oocyte retrieval rate, oocyte maturity, fertilisation rates, embryo cleavage rates, embryo quality and pregnancy rates. Change in ovarian hyperstimulation syndrome (OHSS) rates.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/2001

Overall trial end date

01/04/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Our unit performs about 1500 IVF cycles per year and 70% of the patients have only one cycle of treatment per year. Fifteen per cent of these patients have anovulatory infertility and almost 80% of this group of women will have PCOS. Therefore, about 125 subjects will be suitable for the trial. Assuming 75% of the subjects will participate in the trial, we should be able to recruit 100 patients per year.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

100

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/10/2001

Recruitment end date

01/04/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Obstetrics & Gynaecology
Leeds
LS1 3EX
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

Leeds Teaching 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

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16501038

Publication citations

  1. Results

    Tang T, Glanville J, Orsi N, Barth JH, Balen AH, The use of metformin for women with PCOS undergoing IVF treatment., Hum. Reprod., 2006, 21, 6, 1416-1425, doi: 10.1093/humrep/del025.

Additional files

Editorial Notes