CClinicalTrials.gg
CompletedNCT02544776Updated Mar 25, 2016

Amlodipine on Blood Flow of Preovulatory Follicle in Polycystic Ovarian Patients

An interventional study of Clomifene citrate ( clomid 50 mg ) and Amlodipine in Female Infertility Associated With Anovulation, sponsored by Ahmed Fathy Ali Mohamed Ghanem. Completed. Open to female participants aged 20 Years to 35 Years. Per ClinicalTrials.gov, last updated 2016-03-25.

Sponsored by Ahmed Fathy Ali Mohamed Ghanem · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
20 Years to 35 Years
Sex
Female
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Female Infertility Associated With Anovulation

Keywords

  • pco
  • Amlodipine
03

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • 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: Clomifene citrate ( clomid 50 mg ) · Drug: Amlodipine

  • 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 )

Interventions

  • DrugClomifene citrate ( clomid 50 mg )

    Also known as: clomid ( 50 mg )

  • DrugAmlodipine

    Also known as: Norvasc 5mg

05

What researchers measure

Primary outcomes

  1. change in ovarian artery perfusion

    peak systolic velocity ( psv ) measured by doppler u/s

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

Secondary outcomes

  1. Number of mature follicle

    by vaginal u/s

    Time frame: day 14 of menstrual cycle

  2. endometrial thickening

    by vaginal u/s

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

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT02544776
Lead sponsor
Ahmed Fathy Ali Mohamed Ghanem
Responsible party
Ahmed Fathy Ali Mohamed Ghanem (Resident of Obstetrics and Gynecology, Ain Shams Maternity Hospital) — Sponsor-investigator
First posted
Sep 9, 2015
Start date
Jan 2015
Primary completion
Aug 2015
Completion
Sep 2015
Last update
Mar 25, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion