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.: PACTR201610001802302 Date of Approval: 03/10/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Induction of ovulation
Official scientific title Clomiphene citrate combined with metformin versus letrozole for induction of ovulation in clomiphene- resistant polycystic ovary syndrome: a randomized clinical trial
Brief summary describing the background and objectives of the trial to assess the efficacy of Clomiphene citrate combined with metformin versus letrozole for induction of ovulation in clomiphene- resistant polycystic ovary syndrome
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology,polycystic ovary syndrome
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Drugs
Anticipated trial start date 16/10/2016
Actual trial start date 14/10/2016
Anticipated date of last follow up 16/06/2017
Actual Last follow-up date 08/05/2017
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 200
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Clomiphene citrate 100 mg daily for 5 days combined with metformin 500 mg three times daily Clomiphene citrate 100 mg daily for 5 days combined with metformin 500 mg three times daily 6 months Induction of ovulation 100
Experimental Group letrozole 2.5 mg twice daily for 5 days. letrozole 2.5 mg twice daily for 5 days. 6 months Induction of ovulation 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
A normal semen analysis, normal uterine cavity and bilateral tubal patency were other criteria of inclusion. Patients with FSH >15 mIU/ml, endocrine disorders: hyperprolactinaemia (prolactin ¿ 22 ng/dl), thyroid disorders, cushing's syndrome and acromegaly and patients having organic pelvic disease (endometriosis, leiomyoma, PID, endometrioma or ovarian cyst) upon initial examination as well as husband semen abnormalities (severe oligospermia) were excluded from the study. 20 Year(s) 34 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 20/09/2016 Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Degree of glycemic control Maternal outcome Fetal-neonatal outcome. Degree of glycemic control Maternal outcome Fetal-neonatal outcome.
Primary Outcome ovulation rate, clinical pregnancy rate. ovulation rate, clinical pregnancy rate.
Secondary Outcome patient acceptability and adverse effects of therapy patient acceptability and adverse effects of therapy
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia University hospital 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Rezk Kafrmanawahla El-Bajour 002048 Egypt
Mohamed Rezk 25 Yasin Abd-Elghafar street El-Bajour 002048 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Rezk m_rezk9207@yahoo.com 00201006237186 Kafr Manawahla
City Postal code Country Position/Affiliation
Elbajour 002048 Egypt Lecturer of Obstetrics and Gynecology-Faculty of Medicine-Menoufia University
Role Name Email Phone Street address
Public Enquiries Mohamed Rezk m_rezk9207@yahoo.com 00201006237186 Kafr Manawahla
City Postal code Country Position/Affiliation
Elbajour 002048 Egypt Lecturer of Obstetrics and Gynecology-Faculty of Medicine-Menoufia University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Rezk m_rezk9207@yahoo.com 00201006237186 Kafr Manawahla
City Postal code Country Position/Affiliation
Elbajour 002048 Egypt Lecturer of Obstetrics and Gynecology-Faculty of Medicine-Menoufia 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
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information