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.: PACTR201902584533870 Date of Approval: 12/02/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Could L-carnitine help poor responders to ovarian stimulation?
Official scientific title Could L-carnitine help poor responders to ovarian stimulation?
Brief summary describing the background and objectives of the trial The first description of a patient who was a poor responder occurred 28 years ago . A patient responding with a decreased follicular response and low oestradiol (E2) levels to ovarian stimulation by FSH/HMG was reported, Since then, there are several hundred publications on poor ovarian response (POR), its pathogenesis, clinical characterization and possible treatment .The authors’ conclusions in all these reviews are always the same; there is insufficient evidence to identify the use of any particular intervention to improve treatment outcomes in poor responders. L-carnitine (LC), and its acetylated form, acetyl L-carnitine (ALC), have immense functional capabilities to regulate the oxidative and metabolic status of the female reproductive system. The vulnerability of this system to free radicals demand for advanced strategies to combat them. For this purpose, the ‘quasi vitamins’ LC and ALC can be used either individually, or in combination with each other or with other antioxidants. Our aim is to evaluate the effect of L-carnitine (LC) use in poor responders on their response to stimulation and on pregnancy rate through using it synchronously with ovarian stimulation.
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 28/02/2019
Actual trial start date 28/02/2019
Anticipated date of last follow up 01/10/2019
Actual Last follow-up date 01/10/2019
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group L carnitine 3 tabs per day for 3 months Oral tablets 50
Control Group Placebo No treatment 3 months No treatment 50 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Infertile females resistant to stimulation Any other causes of infertility Adult: 19 Year-44 Year 20 Year(s) 35 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 31/12/2018 IRB Faculty of Medicine Alexandria University
Ethics Committee Address
Street address City Postal code Country
17 Champollion Street, El Mesalah Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Clinical pregnancy 14 days after sperm injection
Secondary Outcome Response to ovarian stimulation for three consecutive cycles after ovarian stimulation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Obstetrics and Gynecology Faculty of Medicine University of Alexandria 12 PortSaid Street ElShatby Alexandria 21526 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Eman Abdelfattah 514 Elhoryaa Road Elwezara Bolkely Alexandria 21531 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Obstetrics and Gynecology Faculty of Medicine University of Alexandria 12 PortSaid Street ElShatby Alexandria 21526 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Tarek Karkoor 12 PortSaid Street ElShatby Alexandria 21526 Egypt
Emad El Deen Khaleefa El Shatby Hospital Infertility Clinic 12 PortSaid Street ElShatby Alexandria 21526 Egypt
Eman Abdelfattah El Shatby Hospital Infertility Clinic 12 PortSaid Street ElShatby Alexandria 21526 Egypt
Amany Ismaiel El Shatby Hospital Infertility Clinic 12 PortSaid Street ElShatby Alexandria 21526 Egypt
Amr Mohsen El Shatby Hospital Infertility Clinic 12 PortSaid Street ElShatby Alexandria 21526 Egypt
Doaa Omar El Shatby Hospital Infertility Clinic 12 PortSaid Street ElShatby Alexandria 21526 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Eman Abdelfattah Eman0eman0eman7@gmail.com 00201284374180 514 Elhoryaa Road Elwezara Bolkely
City Postal code Country Position/Affiliation
Alexandria 21531 Egypt Assistant Professor of Obstetrics and Gynaecology Faculty of Medicine University of Alexandria
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
Role Name Email Phone Street address
Principal Investigator Tarek Karkoor tarekkarkoor@gmail.com 00201223152544 12 PortSaid Street ElShatby
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Professor of Obstetrics and Gynaecology Faculty of Medicine University of Alexandria
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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