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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00795808




Registration number
NCT00795808
Ethics application status
Date submitted
20/11/2008
Date registered
21/11/2008
Date last updated
21/11/2008

Titles & IDs
Public title
PCOSMIC Trial - PolyCystic Ovary Syndrome, Metformin for Infertility With Clomiphene
Scientific title
Multi-Centre Randomised Controlled Trial of the Effectiveness of Metformin and Clomiphene Citrate for Treating Anovulatory Infertility in Women With Polycystic Ovary Syndrome
Secondary ID [1] 0 0
UAuckland
Universal Trial Number (UTN)
Trial acronym
PCOSMIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polycystic Ovary Syndrome 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Metformin
Treatment: Drugs - Placebo
Treatment: Drugs - Metformin + Clomiphene
Treatment: Drugs - Metformin
Treatment: Drugs - Clomiphene

Experimental: BMI > 32 - Women with BMI > 32

Experimental: BMI </= 32 - Women with BMI </= 32


Treatment: Drugs: Metformin
500mg tds for 6 months

Treatment: Drugs: Placebo
One tablet tds for 6 months

Treatment: Drugs: Metformin + Clomiphene
500mg tds + Ovulatory dose for 6 months

Treatment: Drugs: Metformin
500mg tds for 6 months

Treatment: Drugs: Clomiphene
Ovulatory dose for 6 months
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical pregnancy
Timepoint [1] 0 0
within 6 calendar months of randomisation
Secondary outcome [1] 0 0
Live birth
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Adverse events
Timepoint [2] 0 0

Eligibility
Key inclusion criteria
- Women between the age of 18 and 39 years inclusive.

- Anovulatory infertility of duration at least 12 months.

- Polycystic ovary syndrome, based on Rotterdam consensus criteria.

- Normal serum prolactin, thyroid function and 17-hydroxyprogesterone.

- Normal serum prolactin, thyroid function and 17-hydroxyprogesterone;
Minimum age
18 Years
Maximum age
39 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Presence of any other significant infertility factor including male factor, known
tubal disease or history of an ectopic pregnancy, known endometriosis affecting the
fallopian tubes or ovaries.

- Already taking oral hypoglycaemics.

- Diabetics receiving treatment.

- Renal impairment

- Chronic hepatic disease

- Cardiac Disease

- Alcohol dependency

- Pre-disposition to lactic acidosis

- Previous ovarian drilling procedure, gonadotrophin injection therapy, IUI
(intrauterine insemination) or IVF ( in vitro fertilisation).

- For those women who have had previous fertility treatment, the following would be
excluded:

- Women who have had > 5 cycles of clomiphene citrate

- Women who have had > 5 months metformin treatment previously

- Women who have proven to be resistant to 100mg or more of clomiphene citrate.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2008
Sample size
Target
Accrual to date
Final
171
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Auckland Medical Research Foundation
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Mercia Barnes Trust of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
1. Metformin increases the pregnancy rate when added to the standard treatment of
anovulatory polycystic ovary syndrome (PCOS).

2. Metformin in combination with clomiphene, is more effective than clomiphene alone or
metformin alone improves fertility outcomes in women with PCOS of reasonably healthy
body weight (BMI </= 32).

3. Metformin improves fertility outcomes in women with BMI > 32 with PCOS.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00795808
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Neil P Johnson, FRANZCOG
Address 0 0
University of Auckland, fertility Plus & Repromed Auckland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries