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Trial details
Trial details
Dietary Omega 3 supplementation and its effect on oocyte competence and follicular fluid in female patients undergoing IVF: a single prospective interventional study
Current status:
Approved
|
Date registered:
13/10/2021
|
Date last updated:
13/10/2021
Trial version(s)
Current: 07/08/2020
Click here to view the tips and fields' descriptions
Main Information
Primary registry identifying number
LBCTR2021044539
Protocol number
OBS-2019-004
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
07/08/2020
Primary sponsor
Al Hadi IVF Center
Primary sponsor: Country of origin
Lebanon
Public title
Dietary Omega 3 supplementation and its effect on oocyte competence and follicular fluid in female patients undergoing IVF: a single prospective interventional study
Acronym
Scientific title
Dietary Omega 3 supplementation and its effect on oocyte competence and follicular fluid in female patients undergoing IVF: a single prospective interventional study
Acronym
Brief summary of the study: English
We are doing a study about the effect of omega 3 supplementation on ICSI outcomes. There is increasing evidence that omega 3 supplementation prior to ICSI increase the success rate without direct evidence. The project will involve whether taking omega 3 supplementation (known as Vita DHA Materna by U.G.A) or not, and answering a questionnaire about your medical background.
Brief summary of the study: Arabic
نحن نقوم بدراسة بشأن إعطاء الأوميغا 3 قبل عملية أطفال الأنابيب.هناك أدلة متزايدة على أن إستخدام الأوميغا 3 يزيد من نسبة نجاح عملية أطفال الأنابيب دون وجود دراسات ذات مستوى علمي مرتفع تكد على هذه النظرية. سيشمل المشروع إما أخذ حبوب تحتوي على الأوميغا و الأجابة على بعض الأسئلة في بداية العلاج و المتابعة خلال فترة العلاج.
Health conditions/problem studied: Specify
ICSI outcome follicular fluid composition epigenetic modifications oocyte competence Oxidative stress
Interventions: Specify
Group: control Group: 200mg DHA + 50mg EPA Group: 400mg DHA + 100mg EPA Randomly divided
Key inclusion and exclusion criteria: Inclusion criteria
18 < age < 45 < 3 IVF attempts Normal uterine activity
Key inclusion and exclusion criteria: Gender
Female
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
45
Key inclusion and exclusion criteria: Exclusion criteria
The cycles involving percutaneous epididymal sperm aspiration must be excluded.
Type of Study
Type
Interventional
Type of intervention
Dietary interventions
Trial scope
Dose-response
Trial scope: Specify scope
Study design: Allocation
Randomized controlled trial
Study design: Masking
Blinded (masking used)
Study design: Control
Placebo
Study phase
0 (explanatory trials)
Study design: Purpose
Supportive care
Study design: Assignment
Parallel
Pharmaceutical class
EPA and DHA
Therapeutic indication
oxidative stress
Therapeutic benefit
oxidative stress reduction enhance embryo quality
Biospecimen retention
Samples without DNA
Biospecimen description
Follicular Fluid biochemistry
Target sample size
250
Actual enrollment target size
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
01/07/2020
Date of study closure: Type
Anticipated
Date of study closure: Date
01/05/2021
Recruitment status
Recruiting
Date of completion
IPD sharing statement plan
Yes
IPD sharing statement description
All data will be disclosed and confidentially saved on excel sheets
Additional data URL
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Mount Lebanon Hospital
05957000
Sources of Monetary or Material Support
Name
Al Hadi Laboratory and Medical Center
Secondary Sponsors
Name
NA
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Chadi
Fakih
Haret Hreik
Lebanon
03755442
drchadifakih@yahoo.fr
Al Hadi Laboratory and Medical Center
Scientific
Chadi
Fakih
Haret Hreik
Lebanon
03755442
drchadifakih@yahoo.fr
Al Hadi Laboratory and Medical Center
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Al Hadi Laboratory and Medical Center
Chadi Fakih
Doctor
Approved
Al Hadi Laboratory and Medical Center
Ranine Zahwe
Research and Medical Assistant
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Mount Lebanon Hospital
01/07/2020
Dr. Marie Merheb
marie.merheb@mlh.com.lb
05957000
Countries of Recruitment
Name
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
In vitro fertilization
In vitro fertilization (Z31.2)
IVF
Interventions
Intervention
Description
Keyword
Pharmaceutical
Dose
EPA , DHA
Primary Outcomes
Name
Time points
Measure
Oocyte Competence
after 3 months
Fertilization + embryo quality
Key Secondary Outcomes
Name
Time points
Measure
Pregnancy Rate
after 1 month
hCG test
Live Birth Rate
after 9 months of last recruitment
Alive or not
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
Save a PDF copy of the summary of the trial