Amlodipine on Blood Flow of Preovulatory Follicle in Polycystic Ovarian Patients

Female Infertility Associated With Anovulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02544776
• Other study ID #: effect of amlodipine in pco
• Status: Completed
• Phase: N/A
• First received: August 27, 2015
• Last updated: March 24, 2016
• Start date: January 2015
• Est. completion date: September 2015

Study information

• Verified date: March 2016
• Source: Ain Shams Maternity Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anovulation
• Female Infertility Associated With Anovulation
• Infertility, Female

Intervention

Drug:
• Clomifene citrate ( clomid 50 mg )

• Amlodipine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ahmed Fathy Ali Mohamed Ghanem

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in ovarian artery perfusion	peak systolic velocity ( psv ) measured by doppler u/s	day number five and day number 9 of menstrual cycle	No
Secondary	Number of mature follicle	by vaginal u/s	day 14 of menstrual cycle	No
Secondary	endometrial thickening	by vaginal u/s	day number five and day number 9 of menstrual cycle	No