- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01638988
Clomifene Citrate Versus Metformin in First-line Treatment of Infertility in Patients With Polycystic Ovary Syndrome and a Resistance to Insulin
July 24, 2015 updated by: Clinique Ovo
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Quebec
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Montréal, Quebec, Canada, H4P 2S4
- Clinique OVO
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Metformin
|
|
Active Comparator: Clomiphene Citrate
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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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biochemical pregnancy
Time Frame: 1 month
|
Rate of biochemical pregnancy
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ovulation rate
Time Frame: 1 month
|
Ovulation rate
|
1 month
|
Live birth rate
Time Frame: 6 months
|
6 months
|
|
Spontaneous abortion rate
Time Frame: 6 months
|
6 months
|
|
BMI and waist size changing
Time Frame: 6 months
|
6 months
|
|
Insulin resistance changing
Time Frame: 6 months
|
6 months
|
|
AMH correlation/variation in function of Metformin
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jacques Kadoch, Dr, Clinique OVO
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
November 1, 2013
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
July 9, 2012
First Submitted That Met QC Criteria
July 11, 2012
First Posted (Estimate)
July 12, 2012
Study Record Updates
Last Update Posted (Estimate)
July 28, 2015
Last Update Submitted That Met QC Criteria
July 24, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Glucose Metabolism Disorders
- Metabolic Diseases
- Neoplasms
- Endocrine System Diseases
- Disease
- Ovarian Cysts
- Cysts
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Hyperinsulinism
- Polycystic Ovary Syndrome
- Syndrome
- Infertility
- Insulin Resistance
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Estrogen Antagonists
- Reproductive Control Agents
- Fertility Agents, Female
- Fertility Agents
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Metformin
- Clomiphene
- Enclomiphene
- Zuclomiphene
Other Study ID Numbers
- OVO-12-17
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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-
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-
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