PMC:3265112 / 2440-5818
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{"target":"http://pubannotation.org/docs/sourcedb/PMC/sourceid/3265112","sourcedb":"PMC","sourceid":"3265112","source_url":"https://www.ncbi.nlm.nih.gov/pmc/3265112","text":"2. Materials and Methods\nIn this prospective intervention, we studied Abolfazle Clinic's outpatients of the Bushehr University of Medical Sciences in Iran who referred between January 1, 2008, and December 30, 2010. The study was approved by the institutional ethics committee of the Bushehr University of Medical Sciences, and all patients were required to provide written informed consent before the study commenced. Inclusion criteria are as follows. The study group consisted of polycystic ovarian syndrom (PCOS) patients diagnosed according to the Rotterdam criteria [1]. We defined clomiphene citrate (Clomid, Iran Hormone, Tehran, Iran) resistance as failure to achieve adequate follicular maturation after consumption of 3 cycles of cc at 150 mg/day, determined by serial estradiol monitoring and sonography [1]. Patients resistant to clomiphene citrate became candidates for letrozole (Femara, Novartis, QC, Canada) consumption at the step-up of the protocol. Patients information was recorded in Table 1. Exclusion criteria were 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, FSH \u003e 10, poor patient compliance or complications with treatment. The required information was gathered through demographic and infertility interviews using an information list. Each patient was followed for 6 sessions. Estradiol levels (E2) were measured using the ELISA method by RAYTO set and DIAPLUS kit before the administration of HCG. Serial sonography (Hoda 4000, Japan) was conducted from the 10th day of menstruation and depended on follicular size (18–24 mm) from which HCG (human chorionic gonadotropin, Pregnyl, Organon, Oss, The Netherlands) was administered. There were 3 steps in which we prescribed letrozole. In all cases, daily administration began on the 3rd day of the menstrual cycle through to the 7th day (totalling 5 days). In the first step we prescribed letrozole at a dose of 2.5 mg (one tablet). Normal follicular size and endometrial thickness were considered 18–24 mm and 6 mm or more, respectively, [1]. If the follicle was deemed not acceptable, the dose of letrozole was increased at the next cycle. At the second and third steps we prescribed letrozole at a dose of 5 mg daily and 7.5 mg/day, respectively, and according to patient's response, repeated the same dose. In the current study we tested the hypothesis that prescribing letrozole as an ovulation induction agent in infertile women would increase pregnancy rate, ovulation, and follicle number. The primary outcome measure was normal follicular size, and the secondary outcome measure was the clinical pregnancy. Clinical pregnancy was considered as the presence of a gestational sac with fetal heart activity. Letrozole tablets were prescribed by an experienced nurse who thoroughly explained the method of use to the patients. Sonography was done by an experienced radiologist. Statistical analysis was performed by the Statistical Package for Social Science version 11.5 for windows (SPSS Inc., Chicago, IL, USA). The data was analyzed by student's t-test and chi-squared test for linear trend and comparing proportions. A P value of \u003c0.05 was considered to be statistically significant.","divisions":[{"label":"title","span":{"begin":0,"end":24}}],"tracks":[]}