Female Infertility Associated With AnovulationNCT02544776
Amlodipine on Blood Flow of Preovulatory Follicle in Polycystic Ovarian Patients
A study testing Clomifene citrate ( clomid 50 mg ) and Amlodipine in people with Female Infertility Associated With Anovulation, run by Ahmed Fathy Ali Mohamed Ghanem.
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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Female Infertility Associated With Anovulation
- What is being tested?
- Clomifene citrate ( clomid 50 mg ) and Amlodipine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: 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.
Read the detailed description
To know if amlodipine has vasodilator effect on ovarian ar. In pco patient.
- Being tested
- Clomifene citrate ( clomid 50 mg ), Amlodipine
- Keywords
- pco, Amlodipine
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clomifene citrate ( clomid 50 mg )Drug
Also called clomid ( 50 mg )
AmlodipineDrug
Also called Norvasc 5mg
| Study group | Role | What they receive |
|---|---|---|
| Clomifene citrate and Amlodipine | Experimental | 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. Receives: Drug: Clomifene citrate ( clomid 50 mg ); Drug: Amlodipine |
| Clomifene citrate | Active comparator | Clomifene citrate 50mg and once daily at morning starting from day number 5 of menstrual cycle till day number 9 Receives: Drug: Clomifene citrate ( clomid 50 mg ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in ovarian artery perfusion
peak systolic velocity ( psv ) measured by doppler u/s
Measured: day number five and day number 9 of menstrual cycle
Secondary outcomes (2)
Number of mature follicle
by vaginal u/s
Measured: day 14 of menstrual cycle
endometrial thickening
by vaginal u/s
Measured: day number five and day number 9 of menstrual cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startJan 2015
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Infertility Associated With AnovulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed Fathy Ali Mohamed Ghanem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Fathy Ali Mohamed Ghanem, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544776
- Sponsor's protocol ID
- effect of amlodipine in pco
- Status last verified
- Mar 2016
- First submitted
- 27 Aug 2015
- Last updated
- 25 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Amlodipine and Clomid on Blood Flow of Preovulatory Follicle in Polycystic Ovarian Patients
- ClinicalTrials.gov ID
- NCT02544776
- Acronym / sponsor ID
- effect of amlodipine in pco
- Keywords
- pco, Amlodipine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ahmed Fathy Ali Mohamed GhanemUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 9 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clomifene citrate and Amlodipine | Experimental | Drug: Clomifene citrate ( clomid 50 mg ), Drug: AmlodipineAmlodipine 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 | Active comparator | Drug: 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 |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clomifene citrate ( clomid 50 mg )Also: clomid ( 50 mg ) | Drug | Clomifene citrate, Clomifene citrate and Amlodipine |
| AmlodipineAlso: Norvasc 5mg | Drug | Clomifene citrate and Amlodipine |
Primary outcome
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
2 secondary outcomes
Number of mature follicle
Time frame: day 14 of menstrual cycle
endometrial thickening
Time frame: day number five and day number 9 of menstrual cycle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Clomifene citrate ( clomid 50 mg ) and Amlodipine in people with Female Infertility Associated With Anovulation, run by Ahmed Fathy Ali Mohamed Ghanem.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in ovarian artery perfusion (time frame: day number five and day number 9 of menstrual cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2016.