Amlodipine on Blood Flow of Preovulatory Follicle in Polycystic Ovarian Patients

Study Overview
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Brief Summary
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On the basis of the current study, amlodipine seems to be a promising drug on improving uterine, ovarian blood flow, size of pre-ovulatory follicle, midluteal progesterone level and pregnancy outcome in patients with pco.

Detailed Description
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To know if amlodipine has vasodilator effect on ovarian ar. In pco patient.

Official Title
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Effect of Amlodipine and Clomid on Blood Flow of Preovulatory Follicle in Polycystic Ovarian Patients

Conditions
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Female Infertility Associated With Anovulation

Intervention / Treatment
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* Drug: Clomifene citrate ( clomid 50 mg )
* Drug: Amlodipine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Demographic features including females in age of ≥20 & ≤35, and BMI of ≤39. Infertility secondary to polycystic ovary , The choice of polycystic ovary patients will be according to the Rotterdam consensus workshop (Rotterdam, 2004), and the diagnosis of polycystic ovary by ultrasonography will be made according to Adams et al. criteria which are the most often cited (Adams et al., 1985).The Rotterdam criteria as follows: Oligo- or anovulation. Clinical and/or biochemical signs of hyper androgynism The presence of polycystic ovaries on ultrasound scan. Ultrasound findings of enlarged ovaries with multiple small cysts (10-12 or more of 2-9 mm in diameter) scattered around the periphery and highly echogenic stroma Exclusion Criteria: Including other causes of infertility diagnosed during infertility work up. Patients refused to participate or to continue study. Also, hepatic, cardiac, and hypotensive patients will be excluded from the study.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clomifene citrate and Amlodipine<br>Amlodipine 5mg tablet and Clomifene citrate 50 mg tablet once by mouth daily at morning starting from day number 5 of menstrual cycle till day number 9. | Drug: Clomifene citrate ( clomid 50 mg )<br> <br> * Other names: clomid ( 50 mg );Drug: Amlodipine<br> <br> * Other names: Norvasc 5mg;|
| Active Comparator: Clomifene citrate<br>Clomifene citrate 50mg and once daily at morning starting from day number 5 of menstrual cycle till day number 9 | Drug: Clomifene citrate ( clomid 50 mg )<br> <br> * Other names: clomid ( 50 mg );|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in ovarian artery perfusion | peak systolic velocity ( psv ) measured by doppler u/s | day number five and day number 9 of menstrual cycle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of mature follicle | by vaginal u/s | day 14 of menstrual cycle | 
| endometrial thickening | by vaginal u/s | day number five and day number 9 of menstrual cycle | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amlodipine, pco