Amlodipine on Blood Flow of Preovulatory Follicle in Polycystic Ovarian Patients

Not Applicable

Completed

• Conditions: Female Infertility Associated With Anovulation
• Interventions: Drug: Clomifene citrate ( clomid 50 mg ); Drug: Amlodipine

• Registration Number: NCT02544776
• Lead Sponsor: Ahmed Fathy Ali Mohamed Ghanem

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.

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2015-08
• Study First Submitted: 2015-08-27
• Study Completion: 2015-09
• Study First Submitted QC: 2015-09-06
• Study First Posted: 2015-09-09
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-24
• Last Update Posted: 2016-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clomifene citrate and Amlodipine	Clomifene citrate ( clomid 50 mg )	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	Clomifene citrate ( clomid 50 mg )	Clomifene citrate 50mg and once daily at morning starting from day number 5 of menstrual cycle till day number 9
Clomifene citrate and Amlodipine	Amlodipine	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.

Primary Outcome Measures

Name	Time	Method
change in ovarian artery perfusion	day number five and day number 9 of menstrual cycle	peak systolic velocity ( psv ) measured by doppler u/s

Secondary Outcome Measures

Name	Time	Method
Number of mature follicle	day 14 of menstrual cycle	by vaginal u/s
endometrial thickening	day number five and day number 9 of menstrual cycle	by vaginal u/s