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