Clomifene Citrate Versus Metformin in First-line Treatment of Infertility in Patients With Polycystic Ovary Syndrome and a Resistance to Insulin

Last updated: July 24, 2015
Sponsor: OVO R & D
Overall Status: Trial Not Available

Phase

3

Condition

Stress

Hormone Deficiencies

Diabetes And Hypertension

Treatment

N/A

Clinical Study ID

NCT01638988
OVO-12-17
  • Ages 18-35
  • Female

Study Summary

The results of studies conducted until now does not determine what the best way to treat infertility in the first line with patients with Polycystic ovary syndrome (PCOS). This study objective is to determine the best treatment for such patients. The long-term consequence health of women with PCOS are multiple. The woman with PCOS has a risk of developing metabolic diseases, heart diseases, diabetes Type II or anovulatory infertility. The insulin resistance plays an important role in all this medical condition. Clomiphene Citrate (CC) remains the first line treatment to induce ovulation in women with PCOS and anovulatory infertility.

Eligibility Criteria

Inclusion

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, totalcholesterol, Triglycerides, oral glucose tolerance test

Exclusion

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

Study Design

Study Start date:
September 01, 2013
Estimated Completion Date:
December 31, 2015

Connect with a study center

  • Clinique Ovo

    Montréal, Quebec H4P 2S4
    Canada

    Site Not Available

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