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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: www.pactr.org

Trial no.: PACTR201302000417210 Date registered: 2012/09/22
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
Purpose of the trial Treatment
Anticipated trial start date 2012-08-01
Actual trial start date 2012-08-01
Anticipated date of last follow up 2012-12-31
Actual date of last follow up
Anticipated target sample size (number of participants) 90   
Actual target sample size (number of participants)   
Recruitment status Open to recruitment: actively recruiting participants
Secondary Ids Issuing authority/Trial register Links to Secondary ID

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

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
Experimental group Tamoxifen 40 mg/day 5 days 30 Active
Control group Control Gonadotrohin 5 days 30 Active

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
-Unexplained infertility -Patent tubes -Bilateral tubal block -Severe male factor of infertility 18 Years 38 Years 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 2012/04/03 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 Fax
Principal Investigator Prof Mohamed Kandil kandeelcando@yahoo.com 00201005784043
Street address City Postal code Country Position / Affiliation
Egypt
Role Name Email Phone Fax
Public Enquiries Dr Zakaria Sanad zakariasanad@yahoo.com 00201067677065
Street address City Postal code Country Position / Affiliation
Shibin Elkom Egypt Assistant Professor-Department of Ob/Gyn. Faculty of Medicine-Menofyia University
Role Name Email Phone Fax
Scientific Enquiries Dr Mohamed Emarh mohemarh@yahoo.com 00201000649994
Street address City Postal code Country Position / Affiliation
Egypt Assistant Professor-Department of Ob/Gyn. Faculty of Medicine-Menofyia University
Role Name Email Phone Fax
Public Enquiries Dr Sherif Sobhi calister1970@yahoo.com 00201019911034
Street address City Postal code Country Position / Affiliation
Egypt