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.: PACTR202202575907380 Date of Registration: 03/02/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title LETROZOLE AND METFORMIN VERSUS LETROZOLE ALONE FOR OVULATION INDUCTION IN WOMEN WITH POLYCYSTIC OVARIAN SYNDROME: A RANDOMISED CONTROLLED TRIAL
Official scientific title LETROZOLE AND METFORMIN VERSUS LETROZOLE ALONE FOR OVULATION INDUCTION IN WOMEN WITH POLYCYSTIC OVARIAN SYNDROME: A RANDOMISED CONTROLLED TRIAL
Brief summary describing the background and objectives of the trial Polycystic ovary syndrome is is an endocrine disorder characterized by oligomenorrhea, ovarian dysfunction, hyperandronergenism and polycystic ovary morphology. The aim of this study is to compare letrozole and metformin versus letrozole alone for ovulation induction in polycystic ovarian syndrome patients with anovulatory infertility. secondary outcome measure will be to compare conception rates, pregnancy rates betwen letrozole and metformin with letrozole alone among PCOS patients with anovulatory infertility.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) LMLPCOS
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 01/04/2021
Actual trial start date 15/04/2021
Anticipated date of last follow up 02/12/2021
Actual Last follow-up date 03/01/2022
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 66
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 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 letrozole and metformin letrozole 7.5mg in three divided doses metformin 1000mg daily Letrozole for 5 days per cycle Metfromin for 3 consecutive menstrual cycles( 3 months) patient starts metformin 1000mg, 3 weeks before the next menstrual cycle, on the second day of the cycle the patients takes letrozole 2.5mg three times daily for 5 days 40
Control Group letrozole 7.5mg in three divided doses 5 days patient takes letrozole 2.5mg in three times a day for 5 days starting from the second day of the menstrual cycle. 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age 18-40. Normal seminal fluid analysis according to WHO cut off points within the past year. Hysterosalphingography finding of at least one patent tube. Clients should be willing and able to have timed intercourse. BMI>35 Additional cause of infertility Ovarian disease Uterine fibroid Adenomyosis History of previous pelvic surgery Hyperprolactinaemia Thyroid disease Adult: 19 Year-44 Year 18 Year(s) 40 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 13/01/2021 RESEARCH ETHICS COMMITTEE AMINU KANO TEACHING HOSPITAL
Ethics Committee Address
Street address City Postal code Country
NO 1 ZARIA ROAD, KANO kano P.M.B. 34 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Ovulation rates patients will have follicular tracking done on days 10,12 14 and 16 to compare ovulation rates
Secondary Outcome conception rates At the end of the mentrual cycle, when patient misses her period she will have a serum pregnancy test to confirm conception
Secondary Outcome Pregnancy rates Patients that had confirmed conception will be followed to 8weeks of gestation to confirm live intra uterine gestation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
AMINU KANO TEACHING HOSPITAL NO 1 Zaria Road, KANO KANO PMB3452 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
GENERIX GLOBAL INVESTMENT LIMITED AND MEGA LIFE SCIENCENIGERIA LIMITED NO 1 DARMA LINK SARDAUNA CRESCENT , KANO. NIGERIA KANO PMB 4663 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor GENERIX GLOBAL INVESTMENT LIMITED 3/4 Kolawola Shonibare Street,off Coker road Lagos Nigeria Commercial Sector/Industry
Secondary Sponsor Mega life science Ground floor, Ochendo House , plot 6, Guiness Road Lagos Nigeria Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator BADRIYYAH DARMA badriyyahdarma@gmail.com +2348030506262 N0 DARMA LINK, OFF SARDAUNA CRESCENT NASSARAWA.KANO
City Postal code Country Position/Affiliation
Kano PMB 4663 Nigeria SENIOR REGISTRAR
Role Name Email Phone Street address
Scientific Enquiries Raphael Attah Attahraph@yahoo.com +2348060296224 No.1 Zaria Road
City Postal code Country Position/Affiliation
Kano PMB3452 Nigeria Supervosor
Role Name Email Phone Street address
Public Enquiries Sumaila Shuaibu sumailashuaibu@gmail.com +2348096765555 No.1 Zaria Road
City Postal code Country Position/Affiliation
Kano PMB3452 Nigeria Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this research may be provided to qualified researchers working on PCOS. Data or data shared will be coded, with no PIH included. Approval of the request and execution of all agreement are prerequisites to the sharing of data with requesting party. Informed Consent Form Data requests can be submitted 9 month after publication and data will be made accessible for 12 month Access to trial IPD can be requested by qualified researchers engaging in independed scientific research, and will be provided following review and appoval of a research proposal and statistical analysis plan and execution of data sharing agreement.
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