Ovulation induction in women with newly diagnosed polycystic ovary syndrome: a randomised double blind clinical trial comparing clomiphene citrate plus metformin with clomiphene citrate plus placebo
| ISRCTN | ISRCTN55906981 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55906981 |
| Protocol serial number | NTR485 |
| Sponsor | Academic Medical Center (AMC) (The Netherlands) |
| Funder | Merck B.V. (The Netherlands) |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 04/04/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Etelka Moll
Scientific
Scientific
Academic Medical Center
Department of Obstetrics & Gynecology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| E.Moll@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | The Metformin trial |
| Study objectives | To compare the effectiveness of clomiphene citrate with metformin versus clomiphene citrate only in women with newly diagnosed polycystic ovary syndrome with respect to ovulation, pregnancy and spontaneous abortions. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Polycystic Ovary Syndrome (PCOS) |
| Intervention | 1. Metformin 4 dd 500 mg plus clomiphene citrate 50 - 150 mg 2. Control: placebo 4 dd plus clomiphene citrate 50 - 150 mg Patients used the medication as long as they were participating in the study. They stopped taking medication when they were clomiphene citrate resistant, pregnant or dropped out for a different reason. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Clomiphene citrate, metformin |
| Primary outcome measure(s) |
Ovulation. |
| Key secondary outcome measure(s) |
1. Ongoing pregnancy |
| Completion date | 01/06/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 228 |
| Key inclusion criteria | All patients with chronic anovulation World Health Organization (WHO) type II, polycystic ovaries diagnosed by transvaginal ultrasonography and child wish. |
| Key exclusion criteria | 1. Other causes of anovulation 2. Age over 40 years and liver, kidney or heart disease/failure (i.e. abnormal results on liver function tests 3. Serum creatinine concentration greater than 95 umol/l or a history of heart disease/failure) 4. Sperm quality indicating male factor subfertility (total motile count less than 10 x 10^6) |
| Date of first enrolment | 01/06/2001 |
| Date of final enrolment | 01/06/2004 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 24/06/2006 | Yes | No | |
| Results article | results | 01/11/2012 | Yes | No |
