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.: PACTR201910906791073 Date of Approval: 21/10/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Clomiphene Citrate versus Letrozole in Men with Infertility
Official scientific title Effects of Clomiphene Citrate versus Letrozole on Semen Count and Motility in Men with Oligoasthenozoospermia in Osogbo: A Randomized Study.
Brief summary describing the background and objectives of the trial Male factor infertility is a major contributor to the burden of infertility in Sub-saharan Africa. It is major cause of marital disharmony and psychological distress among married couple.There is no standard recommended therapy for male factor infertility and intra-cytoplasmic sperm injection to help men with severe abnormal semen parameters is not readily available as well as affordable.The objective of the study is to compare the improvement in semen parameters following intake of clomiphene citrate to that of letrozole in men with oligoasthenozoospermia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) male infertility
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-male
Purpose of the trial Treatment: Drugs
Anticipated trial start date 20/10/2019
Actual trial start date
Anticipated date of last follow up 29/02/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 140
Actual target sample size (number of participants)
Recruitment status Not yet 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 Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group alternate day 50mg of clomiphene citrate will be given for 3 months alternate day 50mg of clomiphene citrate for 3 months 3 months alternate day 2.5mg of Letrozole for 3 months 70 Active-Treatment of Control Group
Experimental Group LETROZOLE 2.5mg alternate day 3 months 2.5mg of letrozole in alternate days for 3 months 70
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Men with abnormal semen counts Men with abnormal semen motility Men with Azoospermia Men with normal semen count Non consenting men Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 65 Year(s) Male
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 21/03/2019 Ladoke Akintola University of Technoloty Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
P.M.B 5000 OSOGBO Osogbo 230212 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome IMPROVEMENT IN SEMEN COUNT AND MOTILITY FOLLOWING ADMINISTRATION OF CLOMIPHENE CITRATE AND LETROZOLE IN MEN WITH OLIGOASTHENOZOOSPERMIA 3 MONTHS OF DRUGS ADMINISTRATION
Secondary Outcome POSITIVE PREGNANCY TEST IN SPOUSE AFTER TREATMENT 1 YEAR FOLLOW UP
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
LAUTECH TEACHING HOSPITAL OSOGBO STATE SPECIALIST HOSPITAL AYOMIDE WOMEN HEALTH AND FERTILITY CENTRE IDI SEKE OSOGBO,ASUBIARO OSOGBO,POWERLINE OSOGBO. OSOGBO 230212 Nigeria
STATE SPECIALIST HOSPITAL ASUBIARO OSOGBO 230212 Nigeria
AYOMIDE WOMEN HEALTH AND FERTILITY CENTRE POWERLINE OSOGBO 230212 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Akinyele Akinbowale yidi area oke awere owode Osogbo 230212 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor AKINYELE AKINBOWALE yidi junction oke awere owode osogbo 230212 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Johnson Komolafe powerline area osogbo osogbo 230212 Nigeria
Busayo Akinbowale Yidi junction oke awere owode osogbo 230212 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator akinyele akinbowale akinyeleakinbowale.aa@gmail.com 08066563644 YIDI JUNCTION
City Postal code Country Position/Affiliation
OSOGBO 230212 Nigeria SENIOR REGISTRAR
Role Name Email Phone Street address
Public Enquiries AKINBOWALE BUSAYO busayoakinbowale2@gmail.com 08034125952 YIDI JUNCTION
City Postal code Country Position/Affiliation
OSOGBO 230212 Nigeria cheif nursing officer
Role Name Email Phone Street address
Scientific Enquiries JOHNSON KOMOLAFE komosayo@gmail.com 07060916229 POWER LINE
City Postal code Country Position/Affiliation
OSOGBO 230212 Nigeria ASSOCIATE PROFESSOR
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes pre-treatment semen count and motility Post-treatment semen count and motility Age of the participants Weight of the participants Informed Consent Form,Statistical Analysis Plan,Study Protocol 12 months Age >19 and <65 Date Oct 2019 to march 2020
URL Results Available Results Summary Result Posting Date First Journal Publication Date
akinyeleakinbowale.aa@gmail.com 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