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.: PACTR202204757658869 Date of Approval: 06/04/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Traditional clomiphene citrate with phytoestrogen vs traditional clomiphene citrate vs stair step protocol in patients with polycystic ovaries: a randomized controlled study
Official scientific title Traditional clomiphene citrate with phytoestrogen vs traditional clomiphene citrate vs stair step protocol in patients with polycystic ovaries: a randomized controlled study
Brief summary describing the background and objectives of the trial Comparing stair step protocol with phytoestrogen vs traditional protocol with phytoestrogen vs traditional protocol alone effect on pregnancy rate and endometrial thickness in women with polycystic ovary syndome
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/04/2022
Actual trial start date 15/04/2022
Anticipated date of last follow up 15/10/2022
Actual Last follow-up date 15/10/2022
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants) 150
Recruitment status Active, not 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 randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Stair step clomiphene citrate phytoestrogen 50 mg clomiphene citrate for 5 days followed by 100 mg for another 5 days + phytoestrogen given for the whole 10 days 10 days 50 mg clomiphene 5 days followed by 100 mg for another 5 days + phytoestrogen for the whole 10 days 50
Experimental Group Traditional clomiphene phytoestrogen 100 mg clomiphene citrate for 5 days + phytoestrogen for 10 days 10 days Clomiphene citrate 100 mg for 5 days + phytoestrogen for 10 days 50
Control Group Traditional Clomiphene citrate 100 mg for 5 days 5 days Clomiphene citrate 100 mg for 5 days 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age: 25-30 years Primary infertility due to PCO (Rotterdam criteria 2003) No medical disorders No other causes of infertility Not fulfilling the inclusion criteria Known hypersensitivity or previous development of side effects from the used treatment Adult: 19 Year-44 Year 25 Year(s) 30 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 12/01/2022 The O6U REC
Ethics Committee Address
Street address City Postal code Country
6 OCTOBER giza 12585 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Endometrial thickness at the day of hCG trigger Day of hCG trigger
Secondary Outcome Clinical pregnancy rate Visualization of gestational sac by transvaginal ultrasound
Secondary Outcome Multiple pregnancy rate Visualization of gestational sac by transvaginal ultrasound
Secondary Outcome Ovarian hyperstimulation syndrome rate During follow up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
October 6th University Central axis Giza None Egypt
Alkasr alainy Alkasr alainy Cairo Non Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor 6 OCTOBER UNIERSITY Al hossary square 6 october city Non Egypt 6 october university
COLLABORATORS
Name Street address City Postal code Country
Heba hesham abd elfattah Elshiekh zayed city Sheikh zayed None Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Haitham Torky Haithamtorky@yahoo.com +201001230161 Teseen
City Postal code Country Position/Affiliation
Cairo None Egypt October 6th University
Role Name Email Phone Street address
Public Enquiries Ashraf Sobhi Ashrafsobhi@yahoo.com +272376540 6 October street
City Postal code Country Position/Affiliation
Giza None Egypt October 6th University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Bahaa Moahmedbahaa@yahoo.com +201001230161 6 October city
City Postal code Country Position/Affiliation
Giza None Egypt October 6th University
Role Name Email Phone Street address
Public Enquiries Ahmed Badawie Ahmedbadawie@yahoo.com +271405558 6 October
City Postal code Country Position/Affiliation
Giza Non Egypt Teaching assistant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data cannot be shared due to privacy issues Study Protocol data cannot be shared due to privacy issues Availability upon request only for privacy issues
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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