Amlodipine on Blood Flow of Preovulatory Follicle in Polycystic Ovarian Patients

March 24, 2016 updated by: Ahmed Fathy Ali Mohamed Ghanem

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 33 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clomifene citrate and 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.
Drug: Amlodipine
Other Names:
  • Norvasc 5mg
Drug: Clomifene citrate ( clomid 50 mg )
Other Names:
  • clomid ( 50 mg )
Active Comparator: Clomifene citrate
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 )
Other Names:
  • clomid ( 50 mg )

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in ovarian artery perfusion
Time Frame: day number five and day number 9 of menstrual cycle
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
Time Frame: day 14 of menstrual cycle
by vaginal u/s
day 14 of menstrual cycle
endometrial thickening
Time Frame: day number five and day number 9 of menstrual cycle
by vaginal u/s
day number five and day number 9 of menstrual cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ahmed Fathy Ali Mohamed Ghanem

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

August 27, 2015

First Submitted That Met QC Criteria

September 6, 2015

First Posted (Estimate)

September 9, 2015

Study Record Updates

Last Update Posted (Estimate)

March 25, 2016

Last Update Submitted That Met QC Criteria

March 24, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • effect of amlodipine in pco

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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