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

This study has been completed.

Sponsors and Collaborators:	University of Auckland, New Zealand Auckland Medical Research Foundation Mercia Barnes Research Trust of the Royal Australian & new Zealand College of obstetricians and Gynaecologists University of Auckland Research Committee
Information provided by:	University of Auckland, New Zealand
ClinicalTrials.gov Identifier:	NCT00795808

Purpose

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.

Condition	Intervention	Phase
Polycystic Ovary Syndrome	Drug: Metformin Drug: Placebo Drug: Metformin + Clomiphene Drug: Clomiphene	Phase IV

MedlinePlus related topics: Infertility

Drug Information available for: Metformin Metformin hydrochloride Citric acid Sodium Citrate Clomiphene citrate Clomiphene Enclomiphene Zuclomiphene

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by University of Auckland, New Zealand:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	171
Study Start Date:	August 2003
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
BMI > 32: Experimental Women with BMI > 32	Drug: Metformin 500mg tds for 6 months Drug: Placebo One tablet tds for 6 months
BMI </= 32: Experimental Women with BMI </= 32	Drug: Metformin + Clomiphene 500mg tds + Ovulatory dose for 6 months Drug: Metformin 500mg tds for 6 months Drug: Clomiphene Ovulatory dose for 6 months

Eligibility

Ages Eligible for Study:	18 Years to 39 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00795808

Locations

New Zealand
University of Auckland
Auckland, New Zealand

Sponsors and Collaborators

University of Auckland, New Zealand

Auckland Medical Research Foundation

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

University of Auckland Research Committee

Investigators

Principal Investigator:

Neil P Johnson, FRANZCOG

University of Auckland, fertility Plus & Repromed Auckland

More Information

Responsible Party:	University of Auckland, Fertility Plus and Repromed Auckland ( Associate Professor Neil Johnson )
Study ID Numbers:	UAuckland
Study First Received:	November 20, 2008
Last Updated:	November 20, 2008
ClinicalTrials.gov Identifier:	NCT00795808
Health Authority:	New Zealand: Health Research Council

Keywords provided by University of Auckland, New Zealand:

Polycystic ovary syndrome
PCOS
Anovulation
Infertility
Anovulatory polycystic ovary syndrome (PCOS)

Study placed in the following topic categories:

Infertility
Gonadal Disorders
Citric Acid
Metformin
Endocrine System Diseases
Clomiphene
Ovarian Diseases

Genital Diseases, Male
Cysts
Genital Diseases, Female
Polycystic Ovary Syndrome
Endocrinopathy
Anovulation
Ovarian Cysts

Additional relevant MeSH terms:

Estrogen Antagonists
Disease
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Pharmacologic Actions
Adnexal Diseases

Estrogen Receptor Modulators
Neoplasms
Hypoglycemic Agents
Pathologic Processes
Therapeutic Uses
Syndrome
Fertility Agents, Female
Fertility Agents

ClinicalTrials.gov processed this record on January 14, 2009