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
Trial Snapshot
- Phase
- Phase 3
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- Biochemical pregnancy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
Metformin
Intervention: Metformin (Drug)
Clomiphene Citrate
Intervention: Clomiphene citrate (Drug)
Outcomes
Primary Outcomes
Biochemical pregnancy
Time Frame: 1 month
Rate of biochemical pregnancy
Secondary Outcomes
- Ovulation rate(1 month)
- BMI and waist size changing(6 months)
- Live birth rate(6 months)
- AMH correlation/variation in function of Metformin(6 months)
- Spontaneous abortion rate(6 months)
- Insulin resistance changing(6 months)