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.: PACTR201309000638372 Date of Approval: 05/09/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of amlodipine on blood flow of preovulatory follicle in Polycystic ovarian patients: A Randomized Controlled Trial
Official scientific title Effect of amlodipine on blood flow of preovulatory follicle in Polycystic ovarian patients: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Infertility is a global problem, 8-12% of couples experience some form of it. Many researches using modern imaging modalities concluded that a reduction in intraovarian blood vessel resistance is necessary to achieve pregnancy in a natural cycle. Infertility is a global problem, 8-12% of couples experience some form of it. Many researches using modern imaging modalities concluded that a reduction in intraovarian blood vessel resistance is necessary to achieve pregnancy in a natural cycle. Our study is a pioneer one in studying effect of the vasodilator calcium channel blocker, amlodipine, on preovulatory follicle. A group of 30 female infertile patients with PCO who receive induction by clomiphene citrate will be given amlodipine. Pattern of preovulatory follicle blood flow will be studied by color and power Doppler ultrasonography pre and post drug administration. Their results will be compared to a control group who will receive induction by clomiphene citrate and placebo instead of amlodepine. Proofing that amlodipine produce a controlled increase intraovarian blood flow will open a gate for a new use of this drug in the infertile female population.
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 Treatment: Drugs
Anticipated trial start date 01/01/2013
Actual trial start date 05/09/2013
Anticipated date of last follow up 01/09/2013
Actual Last follow-up date 05/09/2013
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Amlodipine 5 mg 5 days in mensterual cycle Calcium channel blocker, used for peripheral vasodilation 30
Control Group placebo single night dose before sleeping 5 days in 2nd menstrual cycle from day 6 to day 10 as the drug (amlodipine) The placebo is a tablet made from inert expient (USP grades) as Hydroxypropylmethyl cellulose , direct compression was done to a flat- faced round punches of 6mm diameter using single punch tablet machine (Stokes-Merril-model 511-7-A). The placebo was manufactured by the department of industrial pharmaceutics in the National Research Centre. 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
a) Demographic features including age of ¿20 & ¿35 BMI of ¿39 b) Infertility secondary to PCO, as indicated by amenorrhea or oligomenorrhea, elevated serum LH levels, normal or low FSH levels, elevated LH/FSH ratio, clinical evidence of androgen excess (acne, hirsutism, alopecia), elevated serum levels of testosterone , 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. other causes of infertility diagnosed during infertility work up, also, hepatic, cardiac, and hypotensive patients 20 Year(s) 35 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 10/02/2013 National Research Centre ethics comittee
Ethics Committee Address
Street address City Postal code Country
El-Bohouth Street (El-Tahrir Street), Dokki, P.O.Box 12622 Cairo 11787 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome progesteron level day 21 of mensterual cycle
Primary Outcome peak systolic velocity, Pulsatility indices and resistant indices of ovarian (vessel supplying preovulatory follicle) and uterine day 13 of 1st and 2nd cycle (before and after drug or placebo administration)
Primary Outcome size of dominant follicle or follicles day 13 of 1st and 2nd cycle (before and after drug or placebo administration)
Secondary Outcome endometrial thickness day 13 of 1st and 2nd cycle (before and after drug or placebo administration)
Secondary Outcome pregnancy rate done after missed menses in any of the 2 cycles under the trial
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
1. Ain Shams University in Obstetrics and Gynecology Hospital in infertility clinic 2. National Research centre Abbassia, Lotfy Al Saiad ST. Cairo 002 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
National Research Centre El-Bohouth Street (El-Tahrir Street), Dokki, P.O.Box 12622 Cairo 11787 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Research Centre El-Bohouth Street (El-Tahrir Street), Dokki, P.O.Box 12622 Cairo 11787 Egypt Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Ain Shams University Abbassia, Lotfy Al Saiad ST. Cairo 002 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Doaa Abdelmageed Saleh Hassan El Faham doaaelfaham@gmail.com 002 0111 539 58 56 1st settelment, Benafsag 4, Villa 23, New Cairo
City Postal code Country Position/Affiliation
Cairo 002 Egypt Specialist in National Research Centre
Role Name Email Phone Street address
Principal Investigator Doaa Abdelmageed Saleh Hassan El Faham drdody_as@hotmail.com 002 0111 539 58 56 1st settelment, Benafsag 4, Villa 23, New Cairo
City Postal code Country Position/Affiliation
Cairo 002 Egypt Specialist in National Research Centre
Role Name Email Phone Street address
Principal Investigator Doaa Abdelmageed Saleh El Faham drdody_as@hotmail.com 002 010 9589 36 24 1st settelment, Benafsag 4, Villa 23, New Cairo
City Postal code Country Position/Affiliation
Cairo 002 Egypt Specialist in National Research Centre
Role Name Email Phone Street address
Public Enquiries Doaa Abdelmageed Saleh El Faham drdody_as@hotmail.com 002 0109 589 36 24 1st settelment, Benafsag 4, Villa 23, New Cairo
City Postal code Country Position/Affiliation
Cairo 002 Egypt Specialist in National Research Centre
Role Name Email Phone Street address
Public Enquiries Osama Mahmoud Azmy osamazmy@yahoo.com 002 0122 31 03084 National Research Center, Reproductive Health Research Departement, Bohoos St., DoKKi
City Postal code Country Position/Affiliation
cairo 002 Egypt Professor of obestetrics and gynecology
Role Name Email Phone Street address
Public Enquiries Adel Shafeek Salah ElDin shafikadel@hotmail.com 002 0100 522 35 86 Ain Shams University, Obesterics ans Gyneclogy Hospital, Abbasia, Lotfy El Said
City Postal code Country Position/Affiliation
cairo 002 Egypt lecturer in Faculty of Medicine
Role Name Email Phone Street address
Scientific Enquiries Adel Shafeek Salah ElDin shafikadel@hotmail.com 002 0100 522 35 86 Ain Shams University, Obesterics ans Gyneclogy Hospital, Abbasia, Lotfy El Said
City Postal code Country Position/Affiliation
Cairo 002 Egypt lecturer in Faculty of Medicine, Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Khaled Kamal Ali khalidk1958@yahoo.com 01223422120 Ain Shams University, Obesterics ans Gyneclogy Hospital, Abbasia, Lotfy El Said
City Postal code Country Position/Affiliation
Cairo 002 Egypt Professor Doctor in Obstetrics and Gynecology
Role Name Email Phone Street address
Scientific Enquiries Osama Mahmoud Azmy osamazmy@yahoo.com 002 0122 31 03084 National Research Center, Reproductive Health Research Departement, Bohoos St., DoKKi
City Postal code Country Position/Affiliation
cairo 002 Egypt Professor of obestetrics and gynecology
REPORTING
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