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Completed

NCT Number: NCT00795808

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

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Anovulation Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Infertility Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Auckland

Auckland, New Zealand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

metformin

Drug

500mg tds for 6 months

Placebo

Drug

One tablet tds for 6 months

Metformin + Clomiphene

Drug

500mg tds + Ovulatory dose for 6 months

Clomiphene

Drug

Ovulatory dose for 6 months

Primary outcomes

  1. Clinical pregnancy

    Time frame: within 6 calendar months of randomisation

Secondary outcomes

  1. Live birth

  2. Adverse events

Sponsors and collaborators

Lead sponsor

University of Auckland, New Zealand

Other

Collaborators

  • Auckland Medical Research Foundation
  • Mercia Barnes Trust of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists

Registry information

Official study title

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

Acronym: PCOSMIC

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Nov 21, 2008
Registry last updated
Nov 21, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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