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

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
OVO R & D
ClinicalTrials.gov Identifier:
NCT01638988
First received: July 9, 2012
Last updated: March 12, 2014
Last verified: March 2014

July 9, 2012
March 12, 2014
September 2013
May 2015   (final data collection date for primary outcome measure)
Biochemical pregnancy [ Time Frame: 1 month ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
    Ovulation rate
  • Live birth rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Spontaneous abortion rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • BMI and waist size changing [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Insulin resistance changing [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • AMH correlation/variation in function of Metformin [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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
Endpoint Classification: Bio-equivalence Study
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
    Other Name: Metformin
  • 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
    Other Name: Clomiphene citrate
  • 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.
 
Suspended
401
December 2015
May 2015   (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
Female
18 Years to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01638988
OVO-12-17
No
OVO R & D
OVO R & D
Not Provided
Principal Investigator: Jacques Kadoch, Dr clinique ovo
OVO R & D
March 2014

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