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

Phase 3

Withdrawn

• Conditions: Polycystic Ovary Syndrome; Insulin Resistance
• Interventions: Drug: Metformin; Drug: Clomiphene citrate

• Registration Number: NCT01638988
• Lead Sponsor: Clinique Ovo

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-09
• Study First Submitted QC: 2012-07-11
• Study First Posted: 2012-07-12
• Study Start: 2013-09
• Primary Completion: 2013-11
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-24
• Last Update Posted: 2015-07-28
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin	Metformin	-
Clomiphene Citrate	Clomiphene citrate	-

Primary Outcome Measures

Name	Time	Method
Biochemical pregnancy	1 month	Rate of biochemical pregnancy

Secondary Outcome Measures

Name	Time	Method
Ovulation rate	1 month	Ovulation rate
BMI and waist size changing	6 months
Spontaneous abortion rate	6 months
Live birth rate	6 months
AMH correlation/variation in function of Metformin	6 months
Insulin resistance changing	6 months

Trial Locations

Locations (1)

Clinique Ovo; 🇨🇦 Montréal, Quebec, Canada