SHD_0516_Ovarian_COS


SHD_0516_COS (IVF) [1]

Inclusion Criteria
  • - Females, age 22 to <46 years
  • - Under IVF or ovulation induction protocols that either have ≤4 oocytes retrieved or greater than 15 oocytes retrieved
  • - Both ovaries present
Exclusion Criteria
  • - Pregnant within past 3 months
  • - PCOS diagnosis following Rotterdam criteria of which 2 out of 3 criteria are met. 1. Oligo-anovulation and/or anovulation (ovarian dysfunction) or, 2. Excess androgen activity (clinical or biological hyperandrogenism) or, 3. Polycystic ovaries (antral follicle excess by gynecologic ultrasound with ≥12 follicles from 2 to 9 mm per ovary and/or ovarian volume ≥10 mL)
  • - subjects with major ovarian abnormalities, including: presence of only one ovary, cysts and solid masses > 2 cm, surgically confirmed endometrioma
  • - subjects with ovarian surgery within past 6 months
  • - subjects currently undergoing treatment for malignancy or positive hCG levels
  • - subjects on hormonal contraceptives within last 3 months
  • - subjects with BMI higher or equal to 40

SHD_0516_OvarianReserve (AFC) [2]

Inclusion Criteria
  • - Females, age 22 to <46 years
  • - Both ovaries present
  • - AFC determined on days 2-4 of menstrual cycles only
  • - AFC values less than or equal to 15, or above 15
Exclusion Criteria
  • - Pregnant within past 3 months
  • - PCOS diagnosis following Rotterdam criteria of which 2 out of 3 criteria are met. 1. Oligo-anovulation and/or anovulation (ovarian dysfunction) or, 2. Excess androgen activity (clinical or biological hyperandrogenism) or, 3. Polycystic ovaries (antral follicle excess by gynecologic ultrasound with ≥12 follicles from 2 to 9 mm per ovary and/or ovarian volume ≥10 mL) - Subjects with major ovarian abnormalities, including: presence of only one ovary, cysts and solid masses > 2 cm.
  • - Subjects with ovarian surgery within past 6 months
  • - Subjects with major endocrine or metabolic disorders, including: diabetes, pituitary, adrenal, pancreas, liver and kidney disease, hypothalamic disorders, high prolactin, congenital hyperplasia, premature ovarian failure and premature ovarian insufficiency.
  • - Subjects currently undergoing treatment for malignancy or positive hCG levels.
  • - Subjects on any hormonal medication in the past 21 days (thyroid hormones permitted).
  • - Subjects on hormonal contraceptives within last 3 months
  • - Subjects with BMI higher or equal to 40.