Trial | NCT00795808  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    sitagliptin clomifene ...

  • Study Participants

    171
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 Metformin improves fertility outcomes in women with BMI > 32 with PCOS.
Study Started
Aug 31
2003
Primary Completion
Oct 31
2008
Study Completion
Oct 31
2008
Last Update
Nov 21
2008
Estimate

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 Metformin

500mg tds for 6 months

Drug Clomiphene

Ovulatory dose for 6 months

BMI > 32 Experimental

Women with BMI > 32

BMI </= 32 Experimental

Women with BMI </= 32

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.
No Results Posted