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
  Purpose

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 Intervention Phase
Polycystic Ovary Syndrome
Insulin Resistance
Drug: Metformin
Drug: Clomiphene citrate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by OVO R & D:

Primary Outcome Measures:
  • Biochemical pregnancy [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Rate of biochemical pregnancy


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 401
Study Start Date: September 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Metformin
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
Other Name: Clomiphene citrate

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01638988

Locations
Canada, Quebec
Clinique Ovo
Montréal, Quebec, Canada, H4P 2S4
Sponsors and Collaborators
OVO R & D
Investigators
Principal Investigator: Jacques Kadoch, Dr clinique ovo
  More Information

No publications provided

Responsible Party: OVO R & D
ClinicalTrials.gov Identifier: NCT01638988     History of Changes
Other Study ID Numbers: OVO-12-17
Study First Received: July 9, 2012
Last Updated: March 12, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Infertility
Insulin Resistance
Polycystic Ovary Syndrome
Syndrome
Adnexal Diseases
Cysts
Disease
Endocrine System Diseases
Genital Diseases, Female
Genital Diseases, Male
Glucose Metabolism Disorders
Gonadal Disorders
Hyperinsulinism
Metabolic Diseases
Neoplasms
Ovarian Cysts
Ovarian Diseases
Pathologic Processes
Citric Acid
Clomiphene
Enclomiphene
Metformin
Zuclomiphene
Anticoagulants
Chelating Agents
Estrogen Antagonists
Estrogen Receptor Modulators
Fertility Agents
Fertility Agents, Female
Hematologic Agents

ClinicalTrials.gov processed this record on October 23, 2014