Infertility Clinical Trial
Official title:
Dosage Optimization for Letrozole Treatment in Clomiphene Resistant Patients With Polycystic Ovary Syndrome: A Prospective Interventional Study
Verified date | January 2008 |
Source | Bushehr University of Medical Science |
Contact | n/a |
Is FDA regulated | No |
Health authority | Iran: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 44 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 35 Years |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Bushehr university of medical science | Bushehr |
Lead Sponsor | Collaborator |
---|---|
Bushehr University of Medical Science |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | normal follicular size | two years | Yes | |
Secondary | clinical and current pregnancy rates | two years | Yes |
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