A randomized clinical trial comparing the effect of intraovarian and subcutaneous injection of corifollitropin alfa in the Duostim protocol in infertile women with premature ovarian failure and poor responders candidates for IVF
Fertility in women with poor ovarian response is one of the challenges ahead. In this study, the Dostim protocol is performed using rFSH as a single intraovarian injection on the day of egg retrieval , and then the Dostim cycle continues. we have decided to perform the Dostim protocol in the form of intraovarian injection, but with CORIFOLLITROPIN ALFA (elonva) instead of rFSH and compare it with the subcutaneous injection of the same drug with the same protocol. Corifolitropin alfa (Elonova).
Design
CLINICAL TRIAL with a control group without blinding was randomized on 3-people (15 people in each group) randomization method: two-allele random blocks - size 4
Settings and conduct
The study is conducted in the infertility clinic of Imam Khomeini Hospital in Tehran. Comparison of Dostim diet by intraovarian and subcutaneous injection
Participants/Inclusion and exclusion criteria
Inclusion criteria
1- Age 32 to 42 years
2-BMI <= 30
3-Poor responder cases with abnormal biomarkers
4- History of non-response in previous cycles (less than 3 oocytes) or first IVF experience
5-Sperm analysis is normal or has the minimum necessary criteria for ICSI
exit criteria
History of autoimmune diseases - coagulation disorders - uterine anomalies - chromosomal and genetic disorders - chronic renal and metabolic diseases - hypo and hyperthyroidism - history of malignancy - endometriosis - history of repeated miscarriage and RIF
Intervention groups
Performing the Dostim protocol as an intraovarian injection, but with CORIFOLLITROPIN ALFA (elonva) instead of rFSH and comparing it with the subcutaneous injection of the same drug with the same protocol
Main outcome variables
Primary outcome: the number and quality of oocytes obtained
Secondary outcomes: number and quality of embryos obtained - biochemical pregnancy - total dose of gonadotropins consumed - and the final cost of treatment in each group
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180409039247N6
Registration date:2023-05-30, 1402/03/09
Registration timing:prospective
Last update:2023-05-30, 1402/03/09
Update count:0
Registration date
2023-05-30, 1402/03/09
Registrant information
Name
Marjan Ghaemibidgoli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8800 4858
Email address
m_ghaemi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized clinical trial comparing the effect of intraovarian and subcutaneous injection of corifollitropin alfa in the Duostim protocol in infertile women with premature ovarian failure and poor responders candidates for IVF
Public title
A randomized clinical trial comparing the effect of intraovarian and subcutaneous injection of corifollitropin alfa in the Duostim protocol in infertile women with premature ovarian failure and poor responders candidates for IVF
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
BMI<= ۳۰
Poor responder cases with abnormal biomarkers AFC :۵_۷،AMH <۰.۵-۱.۱)
History of non-response in previous cycles (less than 3 oocytes) or first ivf experience
Sperm analysis is normal or has the minimum necessary criteria for ICSI
Exclusion criteria:
History of autoimmune diseases - coagulation disorders - uterine anomalies - chromosomal and genetic disorders - chronic renal and metabolic diseases - hypo and hyperthyroidism - history of malignancy - endometriosis - history of repeated miscarriage and RIF
Age
From 32 years old to 42 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
One list of computerized randomization is created by an analyst who is blind to the trial. All participants are blind either. randomization is by blocking by WWW.Sealedenvelop.com by the epidemiologist. The blocks are size 6.
:
AAAABBBB-AAABBBBA-AAABBBAB-AAABBAABB-AABBBBAA-AABBAABB-AABBBAAB intervention group: intraovarian injection and control group: routine treatment (subcutaneous injection)
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 in the research of Imam Khomeini hospital complex
Street address
Imam complex, East Bagherkhan street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2023-03-15, 1401/12/24
Ethics committee reference number
IR.TUMS.IKHC.REC.1402.015
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
The number and quality of oocytes obtained
Timepoint
On the day of puncture
Method of measurement
The number of eggs obtained on the day of puncture with OPU catheter
2
Description
Number and quality of obtained embryos
Timepoint
The day after the puncture in the embryology laboratory
Method of measurement
Under the microscope in the embryology laboratory by the embryologist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Dostim protocol is performed as an intraovarian injection but with CORIFOLLITROPIN ALFA (elonva) instead of rFSH on the day of egg retrieval in the operating room, and then the routine cycle of Dostim continues.
Category
Treatment - Drugs
2
Description
Control group: Dustim protocol is administered as a subcutaneous injection but with CORIFOLLITROPIN ALFA (elonva) instead of rFSH on the day of egg retrieval in the operating room, and then the Dostim routine cycle continues.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Complex
Full name of responsible person
Firoozeh Rakhshani
Street address
East Bagherkhan street, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 0000
Email
info@ikhc.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Quds St. intersection with Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8163 0000
Email
info@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Firoozeh Rakhshani
Position
fellowship infertility
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
East Bagherkhan, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 0000
Email
dr.frakhshanim@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Firoozeh Rakhshani
Position
fellowship infertility
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
East Bagherkhan, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 0000
Email
dr.frakhshanim@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Marjan Ghaemibidgoli
Position
Assissted professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam khomeini hospital
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 8800 4858
Fax
Email
marjan_ghaemi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available