Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effects of Metformin on the Ovarian Response to Gonadotropins for in Vitro Fertilization Treatment in Patients With Polycystic Ovary Syndrome and Predictors of Poor Ovarian Response
Brief Summary: Metformin should be administered with caution and could be potentially dangerous in infertile patients with PCOS who show a poor ovarian response and are undergoing gonadotropin-based ovarian stimulation. However, data that address this point are totally lacking.

On the basis of these considerations, the aim of the current clinical trial was to test the hypothesis that metformin reduces the ovarian response in infertile patients with PCOS who have a potentially poor ovarian response and who undergo gonadotropin stimulation for IVF cycles.


Options:
A: Inclusion Criteria:

* Fulfilling Rotterdam criteria for PCOS
* Infertility more than 1 year
* First or second cycle of IVF/ICSI treatment
* Age below 38 years at inclusion
* BMI below 28 kg/m3 at inclusion
* Willing to be randomised to 4 months metformin or placebo
* Signed written informed consent

Exclusion Criteria:

* Not suitable for starting dose 112.5 IE
* Basal FSH above 10 IU/L
* Known renal disease or s-creatinine above 110 umol/L
* Known liver disease or s-ALAT above 80 IU/L
* Known alcoholism or drug abuse
* Known diabetes mellitus or fasting plasma glucose above 7 mmol/L
* Corticosteroid treatment (oral)
* Treatment with cimetidine, anticoagulants, erythromycin or other macrolides
* Hyperprolactinemia (PRL above 700 mIU/L)
* Abnormal thyroid function tests
* Known congenital adrenal hyperplasia
* Androgen secreting tumours
* Cushing syndrome
* Metformin treatment within the last one month prior to screening
* Unfit to participate for any other reason
B: Inclusion Criteria:

* PCOS
* Prognosis for poor response
* Infertility

Exclusion Criteria:

* Male factor infertility
* Tubal infertility
C: Inclusion Criteria:

* The inclusion criteria restricted the patients to 39 years old with basal FSH \< 10 IU/ml and normal TSH and prolacin.

Exclusion Criteria:

* Exclusion criteria were diabetes mellitus (excluded by GTT), renal or liver disease, associated male factor, documented tubal factor or pelvic adhesions, elevated 17 alfa hydroxyprogesterone level and FSH ≥10 IU/ml. We also excluded the women who started program or medications to reduce their weight and those who their partner has abnormal semen parameters according to the world health organization parameters (WHO, 2010)
D: Inclusion Criteria:

* Women attending with ovulatory PCO due to undergo IVF/ICSI treatment.
* First or second cycle of IVF/ICSI.
* If previously on metformin, a minimum one month washout period was required.
* Polycystic ovaries diagnosed by ultrasound presence of ≥12 follicles measuring 2-9 mm in diameter in at least one ovary and/or increased ovarian volume (≥10 ml).
* Written informed consent.

Exclusion Criteria:

* Clinical manifestations of PCOS, including any of the following:

  1. Oligo- or amenorrhoea with cycles ≥42 days apart.
  2. Anovulation with mid-luteal progesterone \<16 nmol/L.
  3. Biochemical hyperandrogenism with serum testosterone ≥3.5 nmol/L and/or free androgen index \>5 (FAI = \[total testosterone/SHBG\] x 100).
  4. Clinical hyperandrogenism with hirsutism or acne requiring treatment at least weekly.
* Age \>38 years.
* BMI \>35 kg/m2.
* Basal FSH \>12 IU/L.
* Liver disease or ALT \>80 IU/L.
* Renal disease, or creatinine \>130 nmol/L.
* Alcoholism or drug abuse.
* Diabetes mellitus (evaluated by fasting glucose \>6.7mmol/L).
* Per oral steroid treatment in last month.
* Cimetidine, anticoagulation, erythromycin, or other macrolides in last month.
* Hyperprolactinemia (Prolactin \>700 mIU/L).
* Abnormal thyroid function tests (TSH outside of laboratory normal range).
* Congenital adrenal hyperplasia.

Answer: B