Please select the eligibility criteria that correspond to the clinical trial below.
Title: Treatment of PCOS (Polycystic Ovary Syndrome)in Morbidly Obese Women - A Randomized Controlled Prospective Dietary Intervention Study
Brief Summary: This study has two phases:

1. In phase 1 of the study (8 weeks),the effect of two different low calorie diets on manifestations of PCOS, including risk factors for the metabolic syndrome and cardiovascular risk profile will be compared.
2. In phase 2 the long term effect (next 44 weeks) on sustained weight-loss and the above mentioned parameters will be compared and evaluated.


Options:
A: Inclusion Criteria:

* To get the diagnosis polycystic ovary syndrome (PCOS), ultrasonography should reveal at least 1 ovary with PCO according to the Rotterdam diagnostic criteria as well as one of the following two symptoms:

  1. Anovulation/oligoovulation defined as ≥ 35 days during the last year
  2. Clinical signs of hyperandrogenism (hirsutism, acne)

Exclusion Criteria:

* Cardiovascular disease
* Diabetes mellitus
* Other endocrine disease (congenital adrenal hyperplasia, androgen producing tumour, Cushing's syndrome)
* Estrogen/gestagen treatment during the last 3 months
* Breast-feeding the last 6 months
* Antiandrogen treatment the last 3 months
B: Couples Inclusion Criteria:

* Partner with sperm concentration of \>=14 million/mL in at least one ejaculate with motile sperm.
* Ability to have regular intercourse 2-3 times per week during the ovulation induction phase of study.
* At least one patent tube and normal uterine cavity as determined by sonohysterogram, hysterosalpingogram, or hysteroscopy/laparoscopy within the last 3 years, or confirmation of a intrauterine pregnancy within the past 2 years.
* No previous sterilization procedures(vasectomy, tubal ligation) that have been reversed.
* Wanting to seek pregnancy.

Inclusion Criteria:

* Chronic anovulation or oligomenorrhea defined as intermenstrual periods of \>= 45 days or a total of \<=8 periods per year.
* Hyperandrogenism will be an elevated total testosterone \>=50 ng/dL.
* Hirsutism determined by a modified Ferriman-Gallwey Score \>8.
* PCO on ultrasound (12 or more follicles measuring 2-9 mm in diameter).
* BMI \>=27 to \<=42.
* Normal EKG to rule out any abnormalities with the heart.

Exclusion Criteria:

* Current pregnancy.
* Patients on oral contraceptives, depo progestins, or hormonal implants.
* Patients with hyperprolactinemia defined as two prolactin levels at least one week apart \>30 ng/mL.
* Patients with known 21-hydroxylase deficiency by a fasting 17-hydroxyprogesterone (17-OHP) level \<2 ng/mL and ACTH stimulation test as needed, or other enzyme deficiency.
* Patients with menopausal FSH levels \>20 mIU/mL.
* Patients with uncorrected thyroid disease (TSH \<0.45 mIU/ML or \>4.5 mIU/ML).
* Patients diagnosed with Type1 or Type II diabetes.
* Patients with liver disease defined as AST or ALT \>2 times normal or total bilirubin \>2.5 mg/dL.
* Patients with renal disease defined as BUN \>30 mg/dL or serum creatinine \>1.4 mg/dL.
* Patients with significant anemia (Hemoglobin \<10 mg/dL).
* Patients with a history of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident.
* Patients with known heart disease that is likely to be exacerbated by pregnancy.
* Patients with a history of , or suspected cervical carcinoma, endometrial carcinoma, or breast carcinoma. A normal PAP smear or reassuring colposcopy based on current ACOG guidelines will be required.
* Patient with current history of alcohol abuse.
* Patients enrolled simultaneously into other investigative studies.
* Patients taking other medications know to affect reproductive function or metabolism.
* Patients with a suspected adrenal or ovarian tumor secreting androgens.
* Patients with suspected Cushing's syndrome.
* Patients who have undergone a bariatric surgery procedure in the recent past (\<12 months).
* Patients with untreated poorly controlled hypertension defined as systolic blood pressure \>=150 mm Hg or average diastolic \>=100 mm Hg on three measurements obtained 5 minutes apart. If treated, average systolic blood pressure \>= 140 mm Hg or average diastolic \>= 90 mm Hg.
* Patients with medical conditions that represent contraindications to orlistat, OCP, clomiphene, and/or pregnancy.
* Patients currently participating in lifestyle intervention program (Weight Watchers, Atkins Diet, Curves) or lost more than 5% body weight within the last 6 months.
C: Inclusion Criteria:

* PCOS
* Anovulatory infertility
* Obesity (BMI \>30)

Exclusion Criteria:

* Age \<18 or \>35 years
* Neoplastic, metabolic, hepatic, renal, and cardiovascular disorders or other concurrent medical illnesses
* Hypothyroidism, hyperprolactinemia, Cushing's syndrome, and non-classical congenital adrenal hyperplasia
* Current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other drugs know to affect sex hormone levels, carbohydrate metabolism, or appetite
* Organic pelvic diseases, previous pelvic surgery, suspected peritoneal factor infertility, tubal or male factor infertility or sub-fertility
D: Inclusion Criteria:

* Woman (European Caucasian)
* PCOS
* BMI = or \> 35

Exclusion Criteria:

* Cushing syndrome
* Adrenal hyperplasia
* Androgen-producing tumors
* Anovulation caused by hyperprolactinemia
* Pregnancy, breast feeding
* Use of oral contraceptives/hormone treatment/insulin-sensitizing agents

Answer: D