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Trial details
Trial details
The effect of intrauterine administration of human gonadotropin (HCG) on implantation and pregnancy rates in IUI (intrauterine insemination cycles) cycles: a randomized prospective study
Current status:
Approved
|
Date registered:
03/04/2021
|
Date last updated:
22/03/2021
Trial version(s)
Current: 13/02/2021
Click here to view the tips and fields' descriptions
Main Information
Primary registry identifying number
LBCTR2021034751
Protocol number
OBS-2019-005
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
01/07/2020
Primary sponsor
Al Hadi Laboratory and Medical Center
Primary sponsor: Country of origin
Lebanon
Public title
The effect of intrauterine administration of human gonadotropin (HCG) on implantation and pregnancy rates in IUI (intrauterine insemination cycles) cycles: a randomized prospective study
Acronym
Scientific title
The effect of intrauterine administration of human gonadotropin (HCG) on implantation and pregnancy rates in IUI (intrauterine insemination cycles) cycles: a randomized prospective study
Acronym
Brief summary of the study: English
We are doing a study about the effect of administrating HCG hormone in the uterine cavity along with the semen sample during intrauterine insemination to study if there is any modification in live birth rate. HCG has proved its efficacy in IVF procedure but not yet studied in intra uterine insemination.
Brief summary of the study: Arabic
نحن نقوم بمشروع بشأن إضافة هرمون ال HCG الى السائل المنوي قبل حقنه داخل الرحم. تشير الدراسات أن إستخدام هرمون ال HCG يزيد من نسب إنغراس الجنين داخل الرحم خلال عمليات أطفال الأنابيب. و لكن لا يوجد دراسات تشير الى أهمية هذا الهرمون خلال عملية الحقن السائل المنوي داخل الرحم.
Health conditions/problem studied: Specify
The study involves patients suffering from infertility and willing to start an IUI procedure.
Interventions: Specify
The project will involve whether administrating different doses of HCG (known as Choriomon HCG 5000 - IBSA ) along with the semen sample in the uterus or not during intrauterine insemination.
Key inclusion and exclusion criteria: Inclusion criteria
We are inviting 210 patients attending the Al Hadi IVF Center to start the infertility treatment for IUI, in which the age of the female partner is less than 38 years old.
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
38
Key inclusion and exclusion criteria: Exclusion criteria
sperm count less than 1 million and progressive motility less than 30% Advanced maternal age bilateral tubal stenosis
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
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
2
Study design: Purpose
Treatment
Study design: Assignment
Parallel
IMP has market authorization
Yes, Lebanon and Worldwide
IMP has market authorization: Specify the countries
Lebanon and worldwide
Name of IMP
Choriomon 5000
Type of IMP
Others
Type of IMP: Specify
Hormonal
Pharmaceutical class
Hormone
Therapeutic indication
Human chorionic gonadotropin (HCG) is a hormone that supports the normal development of an egg in a woman's ovary, and stimulates the release of the egg during ovulation.
Therapeutic benefit
HCG is used to cause ovulation and to treat infertility in women, and to increase sperm count in men.
Biospecimen retention
None retained
Biospecimen description
Semen sample
Target sample size
200
Actual enrollment target size
Date of first enrollment: Type
Actual
Date of first enrollment: Date
01/08/2020
Date of study closure: Type
Actual
Date of study closure: Date
01/04/2021
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
Not Available
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 Center
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
HCG
Primary Outcomes
Name
Time points
Measure
Live Birth Rate
after 9 months of last recruitment
Alive or not
Key Secondary Outcomes
Name
Time points
Measure
Pregnancy Rate
after 3 months of last recruitment
gestational sac
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