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

Tracking Information

First Received Date ^ICMJE

November 20, 2008

Last Updated Date

November 20, 2008

Start Date ^ICMJE

August 2003

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Clinical pregnancy [ Time Frame: within 6 calendar months of randomisation ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Live birth [ Designated as safety issue: No ]
Adverse events [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Multi-Centre Randomised Controlled Trial of the Effectiveness of Metformin and Clomiphene Citrate for Treating Anovulatory Infertility in Women With Polycystic Ovary Syndrome

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Polycystic Ovary Syndrome

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

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. Epub 2010 Apr 30.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

171

Completion Date

October 2008

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years to 39 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

New Zealand

Administrative Information

NCT Number ^ICMJE

NCT00795808

Other Study ID Numbers ^ICMJE

UAuckland

Has Data Monitoring Committee

Yes

Responsible Party

Associate Professor Neil Johnson, University of Auckland, Fertility Plus and Repromed Auckland

Study Sponsor ^ICMJE

University of Auckland, New Zealand

Collaborators ^ICMJE

Auckland Medical Research Foundation
Mercia Barnes Research Trust of the Royal Australian & new Zealand College of obstetricians and Gynaecologists

Investigators ^ICMJE

Principal Investigator:

Neil P Johnson, FRANZCOG

University of Auckland, fertility Plus & Repromed Auckland

Information Provided By

University of Auckland, New Zealand

Verification Date

November 2008

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

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