Management of anovulation associated with polycystic ovarian syndrome: a randomised trial of clomid versus clomid plus metformin.
| ISRCTN | ISRCTN77388772 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77388772 |
| Secondary identifying numbers | N0112128478 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 19/02/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ramasamy Chandra
Scientific
Scientific
Epsom and St. Helier NHS Trust
Women's Health
St Helier Hospital
Wrythe Lane
Carshalton
SM5 1AA
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | Clomid plus metamorformin is a better treatment option than Clomid alone for subfertility associated with polycystic ovarian syndrome. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nutritional, Metabolic, Endocrine: PolyCystic Ovarian Syndrome (PCOS) |
| Intervention | Women will be randomised in blocks of six into two groups. One group will receive Clomid plus Metformin and the second group will receive Clomid alone. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | clomid versus clomid plus metformin |
| Primary outcome measure | Pregnancy. |
| Secondary outcome measures | 1. Ovulation 2. Level of luteinising hormone 3. Level of testosterone 4. Body Mass Index. |
| Overall study start date | 01/11/2003 |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Subfertile women attending St Helier hospital fertility clinic with problem of anovulation associated with polycystic ovarian syndrome. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/11/2003 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Epsom and St. Helier NHS Trust
Carshalton
SM5 1AA
United Kingdom
SM5 1AA
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Epsom and St Helier University 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 |
