NCT00795808

Brief Summary

  1. 1.Metformin increases the pregnancy rate when added to the standard treatment of anovulatory polycystic ovary syndrome (PCOS).
  2. 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. 3.Metformin improves fertility outcomes in women with BMI \> 32 with PCOS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2003

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2008

Completed
Last Updated

November 21, 2008

Status Verified

November 1, 2008

Enrollment Period

5.2 years

First QC Date

November 20, 2008

Last Update Submit

November 20, 2008

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic ovary syndromePCOSAnovulationInfertilityAnovulatory polycystic ovary syndrome (PCOS)

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy

    within 6 calendar months of randomisation

Secondary Outcomes (2)

  • Live birth

  • Adverse events

Study Arms (2)

BMI > 32

EXPERIMENTAL

Women with BMI \> 32

Drug: MetforminDrug: Placebo

BMI </= 32

EXPERIMENTAL

Women with BMI \</= 32

Drug: Metformin + ClomipheneDrug: MetforminDrug: Clomiphene

Interventions

MetforminDRUG

500mg tds for 6 months

BMI > 32
PlaceboDRUG

One tablet tds for 6 months

BMI > 32
Metformin + ClomipheneDRUG

500mg tds + Ovulatory dose for 6 months

BMI </= 32
ClomipheneDRUG

Ovulatory dose for 6 months

BMI </= 32

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Auckland

Auckland, New Zealand

Location

Related Publications (1)

  • 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.

    PMID: 20435692DERIVED

MeSH Terms

Conditions

Polycystic Ovary SyndromeAnovulationInfertility

Interventions

MetforminClomiphene

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Neil P Johnson, FRANZCOG

    University of Auckland, fertility Plus & Repromed Auckland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 20, 2008

First Posted

November 21, 2008

Study Start

August 1, 2003

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

November 21, 2008

Record last verified: 2008-11

Locations

NZ(1)