ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00795808
Recruitment Status : Completed
First Posted : November 21, 2008
Last Update Posted : November 21, 2008
Sponsor:
Collaborators:
Auckland Medical Research Foundation
Mercia Barnes Trust of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists
Information provided by:
University of Auckland, New Zealand

Brief Summary:
  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 or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Metformin Drug: Placebo Drug: Metformin + Clomiphene Drug: Clomiphene Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 171 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : August 2003
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Clinical pregnancy [ Time Frame: within 6 calendar months of randomisation ]

Secondary Outcome Measures :
  1. Live birth
  2. Adverse events


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00795808


Locations
New Zealand
University of Auckland
Auckland, New Zealand
Sponsors and Collaborators
University of Auckland, New Zealand
Auckland Medical Research Foundation
Mercia Barnes Trust of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists
Investigators
Principal Investigator: Neil P Johnson, FRANZCOG University of Auckland, fertility Plus & Repromed Auckland

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
First Posted: November 21, 2008    Key Record Dates
Last Update Posted: November 21, 2008
Last Verified: November 2008

Keywords provided by University of Auckland, New Zealand:
Polycystic ovary syndrome
PCOS
Anovulation
Infertility
Anovulatory polycystic ovary syndrome (PCOS)

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