Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06403488
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2024-05-03
Brief Title:
Letrozole Dose Increments in PCOS Patients Resistant to Letrozole
Sponsor:
Beni-Suef University
Organization:
Beni-Suef University
Study Overview
Official Title:
Letrozole Dose Increments in PCOS Patients Resistant to Letrozole Ovulation Induction
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objectives To study the effect of Letrozole dose increments on ovulation rate and endometrial thickness as a primary outcomes in patients with polycystic ovary syndrome who previously resistant to letrazole conventional dose and chemical and clinical pregnancy considered as secondary outcomes
Detailed Description:
A prospective cohort clinical trial study will be carried out at Beni Suef outpatient clinic from the period of October 2023 till January 2024 on 102 PCOS patients who received Letrozole for one month showing resistance or anovulation
Inclusion criteria Age 18 - 40 years old normal semen analysis of their male partner and diagnosis of PCOS based on a modified form of the Rotterdam criteria at least two of the mentioned three criteria chronic anovulation oligomenorrhea clinical or biochemical signs of hyperandrogenism and polycystic ovaries on ultrasound
Exclusion criteria Any contraindications for pregnancy and patients received other medications for ovulation induction such as metformin or clomiphene citrate and gonadotropins concomitantly hyperprolactinemia abnormal thyroid functions multiple uterine fibroids suspicion of endometriosis and adenomyosis The study performed on 102 PCOS patients resistant to conventional regimen for Letrozole they were divided into 2 groups Group Areceived Femara 25 mg Novartis pharma 3 tablets per day starting from the second day of the menstrual cycle for 5 days and Group B received femara 25 mg 2 tablets twice daily for 5 days starting from the second day of the cycle Transvaginal ultrasound for tracking follicular growth and endometrial thickness performed on 12th and 14th day of the cycle Primary outcomes of the study were the follicular size and endometrial thickness ovulation detection Secondary outcomes were the biochemical and clinical pregnancy rates
Ethical considerations Approval by the institution ethical committee The Beni-Suef University Faculty of Medicine Research Ethics Committee has approved the study FMBSUREC03102023Ali Individual consent process informed consent was taken after explaining the study objectives and procedures to each patient
Sample size was calculated using Gpower 8 for sample size calculation based on assumption that effect size was 05 For a confidence 95 and power 80 and assumption for using a t-test for two independent means groups the minimum required sample size is 102 participants with 51 participants in each group
Data analysis and statistics Categorical data were reported as numbers and proportions and comparisons were performed using chi-square and the Fisher exact test when appropriate Continuous variables were presented using mean and standard deviation and compared using an unpaired t-test for normally distributed data and Mann-Whitney U test for data was not normally distributed A value of p 005 was considered statistically significant All statistical analyses were performed with Statistical Package for Social Sciences SPSS version 26 SPSS Inc Chicago IL USA
Inclusion criteria Age 18 - 40 years old normal semen analysis of their male partner and diagnosis of PCOS based on a modified form of the Rotterdam criteria at least two of the mentioned three criteria chronic anovulation oligomenorrhea clinical or biochemical signs of hyperandrogenism and polycystic ovaries on ultrasound
Exclusion criteria Any contraindications for pregnancy and patients received other medications for ovulation induction such as metformin or clomiphene citrate and gonadotropins concomitantly hyperprolactinemia abnormal thyroid functions multiple uterine fibroids suspicion of endometriosis and adenomyosis The study performed on 102 PCOS patients resistant to conventional regimen for Letrozole they were divided into 2 groups Group Areceived Femara 25 mg Novartis pharma 3 tablets per day starting from the second day of the menstrual cycle for 5 days and Group B received femara 25 mg 2 tablets twice daily for 5 days starting from the second day of the cycle Transvaginal ultrasound for tracking follicular growth and endometrial thickness performed on 12th and 14th day of the cycle Primary outcomes of the study were the follicular size and endometrial thickness ovulation detection Secondary outcomes were the biochemical and clinical pregnancy rates
Ethical considerations Approval by the institution ethical committee The Beni-Suef University Faculty of Medicine Research Ethics Committee has approved the study FMBSUREC03102023Ali Individual consent process informed consent was taken after explaining the study objectives and procedures to each patient
Sample size was calculated using Gpower 8 for sample size calculation based on assumption that effect size was 05 For a confidence 95 and power 80 and assumption for using a t-test for two independent means groups the minimum required sample size is 102 participants with 51 participants in each group
Data analysis and statistics Categorical data were reported as numbers and proportions and comparisons were performed using chi-square and the Fisher exact test when appropriate Continuous variables were presented using mean and standard deviation and compared using an unpaired t-test for normally distributed data and Mann-Whitney U test for data was not normally distributed A value of p 005 was considered statistically significant All statistical analyses were performed with Statistical Package for Social Sciences SPSS version 26 SPSS Inc Chicago IL USA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None