Dosage Optimization for Letrozole Treatment

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

In a prospective interventional study, 44 Clomiphene resistant infertile patients were selected from Abolfazl Infertility Clinic of Bushehr University of Medical Sciences. Letrozole was given orally in a dose of 2.5mg, 5mg and 7.5mg, respectively. If the patient displayed no response, the dosage was increased. The size of follicle, endometrial thickness, estradiol, complications and clinical pregnancy rate were evaluated as the final outcome.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bushehr University of Medical Science
• Treatments: Clomiphene; Letrozole

Criteria

Inclusion Criteria:

• The study group consisted of polycystic ovarian syndrome(PCOS) patients diagnosed according to the Rotterdam criteria. The investigators defined Clomiphene citrate (Clomid, Iran hormone,Tehran,Iran) resistance as anovulation after consumption of 3 cycles of cc at 150 mg/day, determined by serial estradiol monitoring and sonography. Patients resistant to Clomiphene citrate became candidates for letrozole (Femara,Novartis,Quebec,Canada) consumption at the step-up of the protocol. Patients were between 18 and 39 years of age, body mass index (BMI) was > 19 or < 30 kg/m2 and day 3 follicle-stimulating hormone (FSH) < 12Miu/Ml.

Exclusion Criteria:

• abnormal thyroid Function test

• hyperprolactinoma

• galactorrhea

• male-factor infertility

• tubal and uterine causes of infertility (hysterosalpingography)

• abnormal response in progesterone challenge test which implies no endogenous estrogen production

• poor patient compliance

• complications with treatment