The Effect of Metformin on Different Hormones in PCOS Patients
Condition: Polycystic Ovarian Syndrome
MeSH terms: Polycystic Ovary Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Forty eight PCOS patients were included . The diagnosis of PCOS was made based on the three
      criteria set by the Rotterdam Consensus meeting definition of PCOS (ESHRE, ASRM, 2004). The
      criteria were as follows:

        1. history of chronic anovulation defined as cycle length > 35 days, or less than 9 cycles
           per year or amenorrhoea (cycle length > 12wks),

        2. infertility with hirsutism or acne or elevation of one or more of serum androgen levels

        3. ultrasonographic findings of polycystic ovaries ( increased ovarian volume, more than
           eight follicles in an ovary ranging from 2-10mm).

      the studied subjects were to receive metformin 850 mg twice daily over a period of 6 months.
      Blood samples were collected at the start of the study, before receiving metformin, where
      baseline serum insulin (fasting and 2 hr postprandial), sex hormone binding globulin (SHBG) ,
      total and free testosterone, Dihydroepiandrostenedione sulphate (DHEAS) and Antimullerian
      Hormone (AMH) were obtained before starting metformin. Blood samples were collected at 3 and
      6 months respectively of metformin treatment , to asses its effect on serum levels of the
      previously mentioned hormonal parameters.
    

Detailed description: 
      Forty eight PCOS patients attending the OBGYN clinic at kasr al aini were included in the
      study. The diagnosis of PCOS was made based on the three criteria set by the Rotterdam
      Consensus meeting definition of PCOS (ESHRE, ASRM, 2004). The criteria were as follows:

        1. history of chronic anovulation defined as cycle length > 35 days, or less than 9 cycles
           per year or amenorrhoea (cycle length > 12wks),

        2. infertility with hirsutism or acne or elevation of one or more of serum androgen levels

        3. ultrasonographic findings of polycystic ovaries ( increased ovarian volume, more than
           eight follicles in an ovary ranging from 2-10mm).

      the studied subjects were to receive metformin 850 mg twice daily over a period of 6 months.
      Blood samples were collected at the start of the study, before receiving metformin, where
      baseline serum insulin (fasting and 2 hr postprandial), sex hormone binding globulin (SHBG) ,
      total and free testosterone, Dihydroepiandrostenedione sulphate (DHEAS) and Antimullerian
      Hormone (AMH) were obtained before starting metformin. Blood samples were collected at 3 and
      6 months respectively of metformin treatment , to asses its effect on serum levels of the
      previously mentioned hormonal parameters.

      The effect of metformin on PCOS patients regarding its clinical and radiological parameters
      was also assessed. Each patient was asked to keep a diary of her menstrual periods over the
      study period; to elicit if there could be an effect by metformin on the regulation of
      menstrual cycles secondary to improvement of ovarian function as a result of improving
      insulin resistance in such patients. The effect of metformin on ovarian morphology by
      ultrasound was also assessed at baseline, 3months and 6 months of the study period; ovarian
      volume and number of follicles was noted down at each visit.
    

Intervention name(s): Metformin
Intervention type(s): Drug
Intervention description(s): 850 mg orally twice daily for 6 months
Other intervention name(s): glucophage
Intervention MeSH terms: Metformin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment