The use of metformin in patients with polycystic ovarian syndrome requiring treatment with in vitro fertilisation (IVF)
| ISRCTN | ISRCTN47219228 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47219228 |
| Secondary identifying numbers | N0024120995 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 07/09/2015
- 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
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Mr Richard Howell
Scientific
Scientific
Fertility Unit
Homerton University Hospital NHS Trust
Homerton Row
London
E9 6SR
United Kingdom
| Phone | +44 (0)20 8510 7660 |
|---|---|
| abc@email.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The use of metformin in patients with polycystic ovarian syndrome requiring treatment with in vitro fertilisation (IVF) |
| 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(s) | Not provided at time of registration |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Metformin |
| Primary outcome measure | 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 study start date | 01/01/2003 |
| Overall study end date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 100 |
| Participant inclusion criteria | Patients with PCOS |
| Participant exclusion criteria | Does not meet inclusion criteria |
| Recruitment start date | 01/01/2003 |
| Recruitment end date | 31/12/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Homerton University Hospital NHS Trust
London
E9 6SR
United Kingdom
E9 6SR
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
Government
Homerton University Hospital NHS Trust
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 |
