Please select the eligibility criteria that correspond to the clinical trial below.
Title: Clinical Metabolic and Endocrine Parameters in Response to Metformin and Lifestyle Intervention in Women With Polycystic Ovary Syndrome: A Phase 4 Randomized, Double- Blind and Placebo Control Trial
Brief Summary: Polycystic ovary syndrome is a frequent cause of abnormal menses and infertility. It has also been related to cardiovascular disease.

The objective of this trial is to evaluate the clinical and metabolic efficacy of metformin plus life style modifications in women with polycystic ovary syndrome compared with life style modifications and placebo


Options:
A: 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.
B: Inclusion Criteria

* Eight or fewer menstrual cycles in the past year or intermenstrual periods of 45 days or longer
* Elevated testosterone level
* Good general health
* Sperm concentration in partner of 20 million/ml or greater
* Ability to have intercourse 2-3 times per week
* One functional fallopian tube and normal uterine cavity
C: Inclusion Criteria:

* Women in reproductive age
* With polycystic ovary syndrome defined by hyperandrogenism (elevated serum testosterone concentrations), and oligomenorrhea (cycles of 35 days or longer), or amenorrhea (no menses in the last 6 months) after negative screening pregnancy test

Exclusion Criteria:

* Pregnancy
* Cushing' s syndrome
* Late onset congenital adrenal hyperplasia
* Androgen-secreting tumors
* Uncontrolled thyroid disease
* Hyperprolactinemia
* Diabetes any
* Cardiovascular diseases (Ischaemic heart disease, uncontrolled hypertension, heart failure)
* Acute or chronic infections at baseline
* Renal disease
* Liver disease
* Had taken any medications for at least 3 months before enrolment in the study.
D: Inclusion Criteria:

* 18 years old to menopause
* polycystic ovary syndrome (NICHD criteria)
* BMI of 30 kg/m² or higher
* poor response to previous treatment with metformin for at least 3 months

Exclusion Criteria:

* type 1 or type 2 diabetes mellitus
* history of carcinoma
* Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
* personal or family history of MEN 2
* significant cardiovascular, kidney or hepatic disease
* the use of medications known or suspected to affect reproductive or metabolic functions
* the use of statins, within 90 days prior to study entry

Answer: C