The use of metformin in in vitro fertilisation (IVF) treatment of patients with polycystic ovary syndrome (PCOS)
ISRCTN | ISRCTN37449406 |
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DOI | https://doi.org/10.1186/ISRCTN37449406 |
Secondary identifying numbers | N0436118094 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 29/04/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr AH Balen
Scientific
Scientific
Obstetrics & Gynaecology
C Floor
Clarendon Wing
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom
Phone | +44 (0)113 392 2728 |
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adam.balen@leedsth.nhs.uk |
Study information
Study design | Prospective randomised double-blinded placebo-controlled study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study objectives | 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(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | 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 study start date | 01/10/2001 |
Completion date | 01/04/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | 100 |
Key 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. |
Key exclusion criteria | Not provided at time of registration |
Date of first enrolment | 01/10/2001 |
Date of final enrolment | 01/04/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Obstetrics & Gynaecology
Leeds
LS1 3EX
United Kingdom
LS1 3EX
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Website | http://www.doh.gov.uk |
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Funders
Funder type
Government
Leeds Teaching Hospitals NHS Trust (UK)
No information available
Results and Publications
Intention to publish date | |
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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? |
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Results article | results | 01/06/2006 | Yes | No |