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OpenTrials
Completed

NCT Number: NCT02544776

Amlodipine 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.

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Key information

Conditions

Female Infertility Associated With Anovulation Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clomifene citrate ( clomid 50 mg )

Drug

Other names: clomid ( 50 mg )

Amlodipine

Drug

Other names: Norvasc 5mg

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of mature follicle

    Time frame: day 14 of menstrual cycle

    by vaginal u/s

  2. endometrial thickening

    Time frame: day number five and day number 9 of menstrual cycle

    by vaginal u/s

Sponsors and collaborators

Lead sponsor

Ahmed Fathy Ali Mohamed Ghanem

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 9, 2015
Registry last updated
Mar 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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