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Clomifene Citrate Versus Metformin in First-line Treatment of Infertility in Patients With Polycystic Ovary Syndrome (PCOS) and a Resistance to Insulin. Randomised Controlled Study


Phase 3
18 Years
35 Years
Not Enrolling
Female
Polycystic Ovary Syndrome, Insulin Resistance

Thank you

Trial Information

Clomifene Citrate Versus Metformin in First-line Treatment of Infertility in Patients With Polycystic Ovary Syndrome (PCOS) and a Resistance to Insulin. Randomised Controlled Study


Inclusion Criteria:



- Women aged from 18 to 35

- Infertility for a period of a year or more or 6 month of irregular menstrual cycle

- PCOS under the Rotterdam criteria

- Insulin resistance HOMA-IR > 2.5

- Normal semen analysis values

- Normal values of the following blood analysis: FSH, LH, Estradiol, AMH, TSH,
Prolactine, Fasting glucose level, hemoglobin A1C, AST, ALT, alkaline phosphatase,
SHBG, 17OH progesterone, DHEAS, Androstenedione, total testosterone, LDL, HDL, total
cholesterol, Triglycerides, oral glucose tolerance test

Exclusion Criteria:

- Tubular factor

- Normal ovarian reserve

- Prior use of CC or Metformin, hypoglycemic agents, glucocorticoids, anti-androgen,
weight-loss agent or oral contraceptives in the past 6 months

- Neoplasia

- BMI > 35

- Renal, hepatic or cardiac failure

- Lactic, acidosis antecedent

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Biochemical pregnancy

Outcome Description:

Rate of biochemical pregnancy

Outcome Time Frame:

1 month

Safety Issue:

No

Principal Investigator

Frederick Dzineku, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

clinique ovo

Authority:

Canada: Ethics Review Committee

Study ID:

OVO-12-17

NCT ID:

NCT01638988

Start Date:

October 2013

Completion Date:

June 2015

Related Keywords:

  • Polycystic Ovary Syndrome
  • Insulin Resistance
  • Infertility
  • Insulin Resistance
  • Polycystic Ovary Syndrome

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