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.: PACTR201302000417210 Date of Approval: 22/09/2012
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Assisted Reproduction
Official scientific title Comparison of Gonadotrophins alone and in combination with oral anti-estrogens in women undergoing superovulation and intrauterine insemination
Brief summary describing the background and objectives of the trial The objectives of this trial are too compare the efficacy and cost of different ovulation induction protocols involving gonadotrophins alone and in combination with oral anti-estrogens (clomiphene citrate and tamoxifen)
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Female Infetility,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/08/2012
Actual trial start date 01/08/2012
Anticipated date of last follow up 31/12/2012
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
Recruitment status Recruiting
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 Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Clomiphene citrate 100 mg/day 5 days 30 Active-Treatment of Control Group
Experimental Group Tamoxifen 40 mg/day 5 days 30 Active-Treatment of Control Group
Control Group Control Gonadotrohin 5 days 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Unexplained infertility -Patent tubes -Bilateral tubal block -Severe male factor of infertility 18 Year(s) 38 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 03/04/2012 Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Shibin Elkom - Menofyia Shibin Elkom Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome occurence of clinical pregnancy 6 months - 1 year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menofyia University Hospital Shibin Elkom - Menofyia Shibin Elkom Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Menofyia University Shibin Elkom - Menofyia Shibin Elkom Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Menofyia University Shibin Elkom - Menofyia Shibin Elkom Egypt University
COLLABORATORS
Name Street address City Postal code Country
Zakaria Sanad Shibin Elkom - Menofyia Shibin Elkom Egypt
Mohamed Emarh Shibin Elkom - Menofyia Shibin Elkom Egypt
Sherif Sobhi Shibin Elkom - Menofyia Shibin Elkom Egypt
Mohamed Kandil Shibin Elkom - Menofyia Shibin Elkom Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Kandil kandeelcando@yahoo.com 00201005784043
City Postal code Country Position/Affiliation
Egypt
Role Name Email Phone Street address
Public Enquiries Sherif Sobhi calister1970@yahoo.com 00201019911034
City Postal code Country Position/Affiliation
Egypt
Role Name Email Phone Street address
Public Enquiries Zakaria Sanad zakariasanad@yahoo.com 00201067677065
City Postal code Country Position/Affiliation
Shibin Elkom Egypt Assistant Professor-Department of Ob/Gyn. Faculty of Medicine-Menofyia University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Emarh mohemarh@yahoo.com 00201000649994
City Postal code Country Position/Affiliation
Egypt Assistant Professor-Department of Ob/Gyn. Faculty of Medicine-Menofyia 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