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.: PACTR201602001475928 Date of Approval: 16/02/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Optimized letrozole dose versus traditional use of clomiphene citrate in induction of ovulation in patients with PCOS a prospective randomized cont
Official scientific title Optimized letrozole dose versus traditional use of clomiphene citrate in induction of ovulation in patients with PCOS a prospective randomized controlled trial (OLDVCCI)
Brief summary describing the background and objectives of the trial objective to compare the effects of gradation of letrozole dose starting with 2.5mg versus clomiphene citrate (100 mg) for ovulation induction in women with polycystic ovary syndrome (PCOS). Design: Prospective randomized controlled trial. Setting: maternity hospital Minia University . Patient(s): The study comprised a total of 200 infertile women with PCOS. Intervention(s): Patients were randomized to treatment with letrozole graded doses starting 2.5mg or 100 mg of clomiphene citrate daily . starting on day 3 of menses. Timed intercourse was advised 24 to 36 hours after hCG injection. Main Outcome Measure(s): Primary outcome : pregnancy rates. Secondary outcome :Number of mature follicles, follicle volume, endometrial thickness, serum progesterone , duration to reach dominant follicles.all patient gave informed consent before inclusion in the study, the study has been approved by local ethical committee , all patients in both groups followed for three successive months , and cumulative pregnancy rate in both groups was compared .
Type of trial RCT
Acronym (If the trial has an acronym then please provide) OLDVCCI
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 01/01/2013
Actual trial start date 01/01/2013
Anticipated date of last follow up 01/01/2014
Actual Last follow-up date 16/01/2014
Anticipated target sample size (number of participants) 210
Actual target sample size (number of participants) 200
Recruitment status Stopped early/ terminated
Publication URL
Secondary Ids Issuing authority/Trial register
mail.mu.edu.eg Maternity Hospital Minia University
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 random generated numbers created by computer Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group treatment with letrozole graded dose start with 2.5mg till reach 10mg for 4day each cycle for three successive months start 3rd day of cycle till 6th day of cycle 100
Control Group treatment with clomid 100mg once daily for 5days each cycle for three successive cycles 5days each cycle for three successive cycles start 3rd day of cycle till 7th day of cycle 100 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Patent fallopian tubes proved by hysterosalpingography . ¿ their partners had normal semen analysis parameters according to the modified criteria of the World Health Organization. ¿ Age 18 ¿ 34 years ¿ Combined factors of infertility ¿ Ovarian cyst ¿ Previous ovarian laparoscopic drilling. 18 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 21/12/2012 obstetrics and Gynaecology ethical board
Ethics Committee Address
Street address City Postal code Country
maternity hospital ,Minia university Minia 6111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pregnancy rate since start of treatment and till end of follow up for three successive months
Secondary Outcome Number of mature follicles, follicle volume, endometrial thickness, serum progesterone , duration to reach dominant follicles. since start of treatment and till end of follow up for three successive months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
maternity hospital Minia university Minia university street Minia 6111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Minia Maternity Hospital Minia university street Minia 6111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Minia Maternity Hospital Minia university street Minia 6111 Egypt Hospital
Secondary Sponsor Minia University Minia university street Minia 6111 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Reham elkateeb Taha Hussin Minia 61519 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Reham Elkateeb rehamelkhateeb78@yahoo.com 0021011966648 Taha Hussin
City Postal code Country Position/Affiliation
Minia 611519 Egypt lecturer in Minia university
Role Name Email Phone Street address
Public Enquiries Reham Elkateeb rehamelkhateeb78@yahoo.com 0021011966648 Taha Hussin
City Postal code Country Position/Affiliation
Minia 611519 Egypt lecturer in Minia university
Role Name Email Phone Street address
Scientific Enquiries Reham Elkateeb rehamelkhateeb78@yahoo.com 0021011966648 Taha Hussin
City Postal code Country Position/Affiliation
Minia 611519 Egypt lecturer in Minia 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