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
  Purpose
  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.

Condition Intervention Phase
Polycystic Ovary Syndrome
Drug: Metformin
Drug: Placebo
Drug: Metformin + Clomiphene
Drug: Clomiphene
Phase 4

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

Resource links provided by NLM:


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
Experimental: BMI > 32
Women with BMI > 32
Drug: Metformin
500mg tds for 6 months
Drug: Placebo
One tablet tds for 6 months
Experimental: BMI </= 32
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Neil P Johnson, FRANZCOG University of Auckland, fertility Plus & Repromed Auckland
  More Information

No publications provided by University of Auckland, New Zealand

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Associate Professor Neil Johnson, University of Auckland, Fertility Plus and Repromed Auckland
ClinicalTrials.gov Identifier: NCT00795808     History of Changes
Other Study ID Numbers: UAuckland
Study First Received: November 20, 2008
Last Updated: November 20, 2008
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)

Additional relevant MeSH terms:
Infertility
Polycystic Ovary Syndrome
Genital Diseases, Male
Genital Diseases, Female
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Clomiphene
Enclomiphene
Zuclomiphene
Metformin
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators
Hypoglycemic Agents

ClinicalTrials.gov processed this record on August 20, 2014