A comparison of metformin with placebo in inducing ovulation in patients with anovulatory polycystic ovary syndrome (PCOS)
| ISRCTN | ISRCTN13946714 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13946714 |
| Secondary identifying numbers | N0436043817 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 23/09/2009
- 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
Not provided at time of registration
Contact information
Mr AH Balen
Scientific
Scientific
IVF Unit
C Floor, Clarendon Wing
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
| Phone | +44 (0)113 392 2728 |
|---|---|
| adam.balen@leedsth.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study hypothesis | To compare the efficacy of metformin in the management of anovulatory women with PCOS. |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Anovulatory polycystic ovary syndrome (PCOS) |
| Intervention | Randomised controlled trial. Random allocation to: 1. Metformin 2. Placebo |
| Intervention type | Other |
| Primary outcome measure | Pregnancy/ovulation |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/04/1999 |
| Overall study end date | 01/04/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Not provided at time of registration |
| Participant inclusion criteria | Overweight women with PCOS. |
| Participant exclusion criteria | Does not match inclusion criteria |
| Recruitment start date | 01/04/1999 |
| Recruitment end date | 01/04/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
IVF Unit
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 |
|---|
Funders
Funder type
Hospital/treatment centre
Leeds Teaching Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2006 | Yes | No |
