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

This study has been withdrawn prior to enrollment.
(Previous studies have been done regarding same condition)
Sponsor:
Information provided by (Responsible Party):
OVO R & D
ClinicalTrials.gov Identifier:
NCT01638988
First received: July 9, 2012
Last updated: July 24, 2015
Last verified: July 2015
July 9, 2012
July 24, 2015
September 2013
November 2013   (Final data collection date for primary outcome measure)
Biochemical pregnancy [ Time Frame: 1 month ]
Rate of biochemical pregnancy
Same as current
Complete list of historical versions of study NCT01638988 on ClinicalTrials.gov Archive Site
  • Ovulation rate [ Time Frame: 1 month ]
    Ovulation rate
  • Live birth rate [ Time Frame: 6 months ]
  • Spontaneous abortion rate [ Time Frame: 6 months ]
  • BMI and waist size changing [ Time Frame: 6 months ]
  • Insulin resistance changing [ Time Frame: 6 months ]
  • AMH correlation/variation in function of Metformin [ Time Frame: 6 months ]
Same as current
Not Provided
Not Provided
 
Clomifene Citrate Versus Metformin in First-line Treatment of Infertility in Patients With Polycystic Ovary Syndrome and a Resistance to Insulin
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Polycystic Ovary Syndrome
  • Insulin Resistance
  • Drug: Metformin
    1. cycle 2000 mg of Metformin : Day 1 to day 30; beginning with 1/2 tablet by day with an increasing until 4 pills by day
    2. to 6 cycle 2000 mg of Metformin : Day 1 ot day 30; 4 pills of Metformin by day Positive pregnancy test : 4 pills of Metformin by day until 12 weeks of pregnancy
  • Drug: Clomiphene citrate
    Cycle 1: Day 3 to day 7; 50 mg; 1 tablet of Clomiphene Citrate by day Cycle 2: Day 3 to day 7; 100 mg; 1 tablet of Clomiphene Citrate two times a day Cycle 3 to 6 : Day 3 to day 7; 150 mg; 1 tablet of Clomiphene Citrate 3 times a day
  • Experimental: Metformin
    Intervention: Drug: Metformin
  • Active Comparator: Clomiphene Citrate
    Intervention: Drug: Clomiphene citrate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2015
November 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 35 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01638988
OVO-12-17
No
Not Provided
Not Provided
Not Provided
OVO R & D
OVO R & D
Not Provided
Principal Investigator: Jacques Kadoch, Dr clinique ovo
OVO R & D
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP