Comparative study of the effects of Novel Dual Trigger and delayed HCG with Dual Trigger in poor responder position grope 4 patients in IVF antagonist cycles
Identifying the best treatment in patients with RIF
Design
Clinical trial, with 2 parallel groups, no blinding, randomized, phase 2 on 80 patients. Random number generation software was used for randomization.
Settings and conduct
This study will be conducted as a clinical trial in 1403 in Beheshti Hospital of Isfahan. In this study, the participants will be blinded to the type of medication received
Participants/Inclusion and exclusion criteria
This study is conducted on patients who have recurrent implantation disorder and are younger than 43 years old and are candidates for IVF treatment. Patients with a history of underlying diseases such as diabetes will be excluded from the study.
Intervention groups
Patients participating in this study will be divided into 2 groups. The first group is treated with Decapeptyl ampoule in the IVF cycle. The second group is subjected to dual HCG and Decapeptyl.
Main outcome variables
Chemical preganncy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240610062068N2
Registration date:2024-07-11, 1403/04/21
Registration timing:prospective
Last update:2024-07-11, 1403/04/21
Update count:0
Registration date
2024-07-11, 1403/04/21
Registrant information
Name
Farnoosh Farahbod
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3622 7184
Email address
farnoosh_farahbod@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effects of Novel Dual Trigger and delayed HCG with Dual Trigger in poor responder position grope 4 patients in IVF antagonist cycles
Public title
Effect of Novel Dual Trigger and Delayed HCG with Dual Trigger in Poor Responder position grope 4 patients in antagonistic IVF cycles
First, the number of numbers between 1 and 100 will be generated according to the number of samples with the help of random number generation software. Then the generated sequence will be placed in the sealed envelope. An envelope will be opened according to the order of entry of the participants and the numerical sequence inside will be determined. If the sequence is between 0 and 50, the person is in the first group and if it is between 51 and 100, the person is in the second group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Approval date
2024-06-08, 1403/03/19
Ethics committee reference number
IR.ARI.MUI.REC.1403.039
Health conditions studied
1
Description of health condition studied
Recurrent implantation failure
ICD-10 code
N98.2
ICD-10 code description
Complications of attempted introduction of fertilized ovum following in vitro fertilization
Primary outcomes
1
Description
Chemical pregnancy
Timepoint
3 months later
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: receiving ampoule decapeptyl in the amount of 0.2 mg. 1 turn Made by Ferring, Germany. Subcutaneously during 1 session
Category
Treatment - Drugs
2
Description
Intervention group: receiving ampoule decapeptyl in the amount of 0.2 mg. 1 turn Made by Ferring, Germany. Subcutaneously during 1 session. along with 5000 units of HCG subcutaneously during 1 session made by Aburihan company
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti hospital
Full name of responsible person
Farnoosh Farahbod
Street address
Beheshti
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
farnoosh_farahbod@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farnoosh Farahbod
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
farnoosh_farahbod@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farnoosh farahbod
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
farnoosh_farahbod@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farnoosh Farahbod
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
farnoosh_farahbod@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD