Insulin Resistance, Polycystic Ovary Syndrome
Conditions
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.
Interventions
DRUGMetformin
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
DRUGClomiphene 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
Sponsors
Clinique Ovo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical pregnancy | 1 month | Rate of biochemical pregnancy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Live birth rate | 6 months | — |
| Spontaneous abortion rate | 6 months | — |
| Ovulation rate | 1 month | Ovulation rate |
| Insulin resistance changing | 6 months | — |
| AMH correlation/variation in function of Metformin | 6 months | — |
| BMI and waist size changing | 6 months | — |
Countries
Canada
Outcome results
None listed