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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

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ClinicalTrials.gov Identifier: NCT01638988
Recruitment Status : Withdrawn (Previous studies have been done regarding same condition)
First Posted : July 12, 2012
Last Update Posted : July 28, 2015
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Insulin Resistance Drug: Metformin Drug: Clomiphene citrate Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2013
Primary Completion Date : November 2013
Estimated Study Completion Date : December 2015

Arms and Interventions

Arm Intervention/treatment
Experimental: Metformin 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
Active Comparator: Clomiphene Citrate 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

Outcome Measures

Primary Outcome Measures :
  1. Biochemical pregnancy [ Time Frame: 1 month ]
    Rate of biochemical pregnancy

Secondary Outcome Measures :
  1. Ovulation rate [ Time Frame: 1 month ]
    Ovulation rate

  2. Live birth rate [ Time Frame: 6 months ]
  3. Spontaneous abortion rate [ Time Frame: 6 months ]
  4. BMI and waist size changing [ Time Frame: 6 months ]
  5. Insulin resistance changing [ Time Frame: 6 months ]
  6. AMH correlation/variation in function of Metformin [ Time Frame: 6 months ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01638988

Canada, Quebec
Clinique Ovo
Montréal, Quebec, Canada, H4P 2S4
Sponsors and Collaborators
Principal Investigator: Jacques Kadoch, Dr clinique ovo
More Information

Responsible Party: OVO R & D
ClinicalTrials.gov Identifier: NCT01638988     History of Changes
Other Study ID Numbers: OVO-12-17
First Posted: July 12, 2012    Key Record Dates
Last Update Posted: July 28, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Insulin Resistance
Polycystic Ovary Syndrome
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Genital Diseases, Male
Genital Diseases, Female
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Hypoglycemic Agents
Physiological Effects of Drugs
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action