PCOSMIC Trial - PolyCystic Ovary Syndrome, Metformin for Infertility With Clomiphene

This study has been completed.
Sponsor:
Collaborators:
Auckland Medical Research Foundation
Mercia Barnes Research Trust of the Royal Australian & new Zealand College of obstetricians and Gynaecologists
Information provided by:
University of Auckland, New Zealand
ClinicalTrials.gov Identifier:
NCT00795808
First received: November 20, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted

November 20, 2008
November 20, 2008
August 2003
October 2008   (final data collection date for primary outcome measure)
Clinical pregnancy [ Time Frame: within 6 calendar months of randomisation ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Live birth [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
PCOSMIC Trial - PolyCystic Ovary Syndrome, Metformin for Infertility With Clomiphene
Multi-Centre Randomised Controlled Trial of the Effectiveness of Metformin and Clomiphene Citrate for Treating Anovulatory Infertility in Women With Polycystic Ovary Syndrome
  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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Polycystic Ovary Syndrome
  • Drug: Metformin
    500mg tds for 6 months
  • Drug: Placebo
    One tablet tds for 6 months
  • Drug: Metformin + Clomiphene
    500mg tds + Ovulatory dose for 6 months
  • Drug: Clomiphene
    Ovulatory dose for 6 months
  • Experimental: BMI > 32
    Women with BMI > 32
    Interventions:
    • Drug: Metformin
    • Drug: Placebo
  • Experimental: BMI </= 32
    Women with BMI </= 32
    Interventions:
    • Drug: Metformin + Clomiphene
    • Drug: Metformin
    • Drug: Clomiphene
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
171
October 2008
October 2008   (final data collection date for primary outcome measure)

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.
Female
18 Years to 39 Years
Yes
Contact information is only displayed when the study is recruiting subjects
New Zealand
 
NCT00795808
UAuckland
Yes
Associate Professor Neil Johnson, University of Auckland, Fertility Plus and Repromed Auckland
University of Auckland, New Zealand
  • Auckland Medical Research Foundation
  • Mercia Barnes Research Trust of the Royal Australian & new Zealand College of obstetricians and Gynaecologists
Principal Investigator: Neil P Johnson, FRANZCOG University of Auckland, fertility Plus & Repromed Auckland
University of Auckland, New Zealand
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP