Back to resultsAmlodipine on Blood Flow of Preovulatory Follicle in Polycystic Ovarian Patients
Primary Purpose
Female Infertility Associated With Anovulation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Clomifene citrate ( clomid 50 mg )
Amlodipine
Sponsored by
About this trial
This is an interventional treatment trial for Female Infertility Associated With Anovulation focused on measuring pco, Amlodipine
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Clomifene citrate and Amlodipine
Clomifene citrate
Arm Description
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.
Clomifene citrate 50mg and once daily at morning starting from day number 5 of menstrual cycle till day number 9
Outcomes
Primary Outcome Measures
change in ovarian artery perfusion
peak systolic velocity ( psv ) measured by doppler u/s
Secondary Outcome Measures
Number of mature follicle
by vaginal u/s
endometrial thickening
by vaginal u/s
Full Information
NCT ID
NCT02544776
First Posted
August 27, 2015
Last Updated
March 24, 2016
Sponsor
Ahmed Fathy Ali Mohamed Ghanem
1. Study Identification
Unique Protocol Identification Number
NCT02544776
Brief Title
Amlodipine on Blood Flow of Preovulatory Follicle in Polycystic Ovarian Patients
Official Title
Effect of Amlodipine and Clomid on Blood Flow of Preovulatory Follicle in Polycystic Ovarian Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmed Fathy Ali Mohamed Ghanem
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
To know if amlodipine has vasodilator effect on ovarian ar. In pco patient.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Infertility Associated With Anovulation
Keywords
pco, Amlodipine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clomifene citrate and Amlodipine
Arm Type
Experimental
Arm Description
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.
Arm Title
Clomifene citrate
Arm Type
Active Comparator
Arm Description
Clomifene citrate 50mg and once daily at morning starting from day number 5 of menstrual cycle till day number 9
Intervention Type
Drug
Intervention Name(s)
Clomifene citrate ( clomid 50 mg )
Other Intervention Name(s)
clomid ( 50 mg )
Intervention Type
Drug
Intervention Name(s)
Amlodipine
Other Intervention Name(s)
Norvasc 5mg
Primary Outcome Measure Information:
Title
change in ovarian artery perfusion
Description
peak systolic velocity ( psv ) measured by doppler u/s
Time Frame
day number five and day number 9 of menstrual cycle
Secondary Outcome Measure Information:
Title
Number of mature follicle
Description
by vaginal u/s
Time Frame
day 14 of menstrual cycle
Title
endometrial thickening
Description
by vaginal u/s
Time Frame
day number five and day number 9 of menstrual cycle
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Amlodipine on Blood Flow of Preovulatory Follicle in Polycystic Ovarian Patients
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