Back to resultsPCOSMIC Trial - PolyCystic Ovary Syndrome, Metformin for Infertility With Clomiphene (PCOSMIC)
Primary Purpose
Polycystic Ovary Syndrome
Status
Completed
Phase
Phase 4
Locations
New Zealand
Study Type
Interventional
Intervention
Metformin
Placebo
Metformin + Clomiphene
Metformin
Clomiphene
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic ovary syndrome, PCOS, Anovulation, Infertility, Anovulatory polycystic ovary syndrome (PCOS)
Eligibility Criteria
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;
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.
Sites / Locations
- University of Auckland
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
BMI > 32
BMI </= 32
Arm Description
Women with BMI > 32
Women with BMI </= 32
Outcomes
Primary Outcome Measures
Clinical pregnancy
Secondary Outcome Measures
Live birth
Adverse events
Full Information
NCT ID
NCT00795808
First Posted
November 20, 2008
Last Updated
November 20, 2008
Sponsor
University of Auckland, New Zealand
Collaborators
Auckland Medical Research Foundation, Mercia Barnes Trust of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists
1. Study Identification
Unique Protocol Identification Number
NCT00795808
Brief Title
PCOSMIC Trial - PolyCystic Ovary Syndrome, Metformin for Infertility With Clomiphene
Acronym
PCOSMIC
Official Title
Multi-Centre Randomised Controlled Trial of the Effectiveness of Metformin and Clomiphene Citrate for Treating Anovulatory Infertility in Women With Polycystic Ovary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Auckland, New Zealand
Collaborators
Auckland Medical Research Foundation, Mercia Barnes Trust of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Metformin increases the pregnancy rate when added to the standard treatment of anovulatory polycystic ovary syndrome (PCOS).
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).
Metformin improves fertility outcomes in women with BMI > 32 with PCOS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Polycystic ovary syndrome, PCOS, Anovulation, Infertility, Anovulatory polycystic ovary syndrome (PCOS)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
171 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BMI > 32
Arm Type
Experimental
Arm Description
Women with BMI > 32
Arm Title
BMI </= 32
Arm Type
Experimental
Arm Description
Women with BMI </= 32
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
500mg tds for 6 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One tablet tds for 6 months
Intervention Type
Drug
Intervention Name(s)
Metformin + Clomiphene
Intervention Description
500mg tds + Ovulatory dose for 6 months
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
500mg tds for 6 months
Intervention Type
Drug
Intervention Name(s)
Clomiphene
Intervention Description
Ovulatory dose for 6 months
Primary Outcome Measure Information:
Title
Clinical pregnancy
Time Frame
within 6 calendar months of randomisation
Secondary Outcome Measure Information:
Title
Live birth
Title
Adverse events
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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;
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil P Johnson, FRANZCOG
Organizational Affiliation
University of Auckland, fertility Plus & Repromed Auckland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Auckland
City
Auckland
Country
New Zealand
12. IPD Sharing Statement
Citations:
PubMed Identifier
20435692
Citation
Johnson NP, Stewart AW, Falkiner J, Farquhar CM, Milsom S, Singh VP, Okonkwo QL, Buckingham KL; REACT-NZ (REproduction And Collaborative Trials in New Zealand), a multi-centre fertility trials group. PCOSMIC: a multi-centre randomized trial in women with PolyCystic Ovary Syndrome evaluating Metformin for Infertility with Clomiphene. Hum Reprod. 2010 Jul;25(7):1675-83. doi: 10.1093/humrep/deq100. Epub 2010 Apr 30.
Results Reference
derived
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PCOSMIC Trial - PolyCystic Ovary Syndrome, Metformin for Infertility With Clomiphene
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