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

Insulin Resistance Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01638988
• Other study ID #: OVO-12-17
• Status: Withdrawn
• Phase: Phase 3
• First received: July 9, 2012
• Last updated: July 24, 2015
• Start date: September 2013
• Est. completion date: December 2015

Study information

• Verified date: July 2015
• Source: OVO R & D
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility
• Insulin Resistance
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Metformin
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 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
• 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

Locations

Country	Name	City	State
Canada	Clinique Ovo	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
OVO R & D

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical pregnancy	Rate of biochemical pregnancy	1 month	No
Secondary	Ovulation rate	Ovulation rate	1 month	No
Secondary	Live birth rate		6 months	Yes
Secondary	Spontaneous abortion rate		6 months	No
Secondary	BMI and waist size changing		6 months	No
Secondary	Insulin resistance changing		6 months	No
Secondary	AMH correlation/variation in function of Metformin		6 months	No