Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201708002485292 Date of Approval: 30/07/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of amlodipine on blood flow of preovulatory follicle in women with clomiphene resistant polycystic ovaries: a randomized controlled trial
Official scientific title Effect of amlodipine on blood flow of preovulatory follicle in women with clomiphene resistant polycystic ovaries: a randomized controlled trial
Brief summary describing the background and objectives of the trial Adding a vasodilator to ovulation induction protocols may improve blood flow to the ovaries and ovulation rate and consequently pregnancy rate.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infertility,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial amlodipine
Anticipated trial start date 15/01/2017
Actual trial start date 15/01/2017
Anticipated date of last follow up 15/05/2017
Actual Last follow-up date 15/05/2017
Anticipated target sample size (number of participants) 124
Actual target sample size (number of participants) 124
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Clomiphene citrate + amlodipine Clomiphene citrate 150 mg once daily + amlodipine 5 mg once daily 5 days Clomiphene citrate + amlodipine 62
Control Group Clomiphene citrate + placebo Clomiphene citrate 150 mg once daily + methyle cellulose 5 mg once daily 5 days Clomiphene citrate + placebo 62 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Infertile women with polycystic ovaries diagnosed by Rotterdam criteria 2) clomiphene citrate resistance at a dose of 150 mg daily for at least 3 cycles 1) Presence of other endocrine abnormalities 2) Presence of other medical disease. 3) Other causes of infertility. 4) Use of contraception for the previous year. 20 Year(s) 40 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/01/2017 Air Force specialized hospital
Ethics Committee Address
Street address City Postal code Country
El-Teseen (90 street) Cairo None Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pulsatility index Time of ovulation triggering
Secondary Outcome Clinical Pregnancy rate By detection of Positive fetal heart by transvaginal ultrasound at 6 weeks
Secondary Outcome Endometrial thickness At the time of ovulation triggering
Secondary Outcome Ovulation rate Midluteal serum progesterone
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Al-Galaa Teaching Hospital Al-Galaa street Downtown Cairo None Egypt
6th October University Hospital Central axis- 6th October city 6th October city-Cairo None Egypt
Air Force Specialized Hospital El-Teseen street ( 90 street) Cairo None Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
None None None None Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Airforce specialized hospital El-teseen (90 street) Cairo None Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Haitham Torky Central axis-6 October 6 october city-Cairo None Egypt
Ali Ahmed Al-Galaa street Downtown Cairo None Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Haitham Torky haithamtorky@yahoo.com +201001230161 Central axis- 6 october city
City Postal code Country Position/Affiliation
Cairo None Egypt Professor of obstetrics and gynecology 6th october university
Role Name Email Phone Street address
Public Enquiries Haitham Torky Haithamtorky@yahoo.com +201001230162 Central axis- 6 october city
City Postal code Country Position/Affiliation
Cairo None Egypt Professor obstetrics and gynecology 6 october university
Role Name Email Phone Street address
Scientific Enquiries Haitham Torky Haithamtorky@yahoo.com +201001230162 Central axis-6 october city
City Postal code Country Position/Affiliation
Cairo None Egypt Professor of obstetrics and gynecology 6 october university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information