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

Ovo Clinic

Status and phase

Withdrawn

Phase 3

Conditions

Insulin Resistance

Polycystic Ovary Syndrome

Treatments

Drug: Metformin

Drug: Clomiphene citrate

Study type

Interventional

Funder types

Industry

Identifiers

NCT01638988

OVO-12-17

Details and patient eligibility

About

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.

Sex

Female

Ages

18 to 35 years old

Volunteers

No Healthy Volunteers

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