Investigating the effect of corticosteroids in improving the results of embryo transfer in infertile patients with endometriosis in Akbarabadi Hospital, Tehran.
Determining the effect of corticosteroids in improving fertility results from frozen embryo transfer in infertile patients with endometriosis
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 101 patients. Rand function of Excel software was used for randomization.
Settings and conduct
Two groups of infertile patients with pelvic endometriosis in the infertility department of Akbarabadi Hospital in Tehran before the start of the frozen embryo transfer cycle were subjected to suppression treatment with three monthly doses of GNRH economizer for three months and 10 weeks after taking GNRH agonist to the intervention group of 2.5 ml Gram prednisolone was given orally. The results of embryo transfer in two groups have been compared.
Participants/Inclusion and exclusion criteria
Entry conditions: women aged 20 to 40 years and having evidence of endometriosis based on laparoscopy evidence, conditions of non-entry: absence of severe sperm disorder in the patient's wife, absence of thrombophilia and autoimmune disease, absence of hormonal medication and immunosuppression in the patient, and patient's lack of consent
Intervention groups
Two groups of infertile patients with endometriosis who are candidates for embryo transfer, the intervention group receives corticosteroids and the control group receives placebo
Main outcome variables
chemical pregnancy; Clinical pregnancy; ongoing pregnancy; Miscarriage; Live birth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231015059725N1
Registration date:2023-11-02, 1402/08/11
Registration timing:retrospective
Last update:2023-11-02, 1402/08/11
Update count:0
Registration date
2023-11-02, 1402/08/11
Registrant information
Name
Azadeh Shiralizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3627 2597
Email address
azadehshiralizadeh96@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-01, 1400/12/10
Expected recruitment end date
2023-08-11, 1402/05/20
Actual recruitment start date
2022-04-09, 1401/01/20
Actual recruitment end date
2023-09-11, 1402/06/20
Trial completion date
2023-09-25, 1402/07/03
Scientific title
Investigating the effect of corticosteroids in improving the results of embryo transfer in infertile patients with endometriosis in Akbarabadi Hospital, Tehran.
Public title
Effect of corticosteroid in improving the results of embryo transfer in patients with endometriosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 and 40 years
Having endometriosis based on laparoscopic evidence
Exclusion criteria:
presence of severe sperm disorders in the patient's wife based on WHO 2021 criteria
congenital or acquired uterine anomalies in the patient
Suffering from thrombophilic diseases such as hemophilia
Suffering from autoimmune diseases such as lupus
The use of hormonal treatments by the individual
Taking immunosuppressant drugs by the individual
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
110
Actual sample size reached:
101
Randomization (investigator's opinion)
Randomized
Randomization description
First, we create a table of random numbers using a computer, then we randomly select a number from the table of real numbers for the first patient after obtaining informed consent for random allocation. For the next patients, we move one house to the right in the table of random numbers, and if the numbers are even, they will be assigned to the intervention group, and if the numbers are odd, they will be assigned to the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The blinding of the study was such that the outcome evaluator and the data analyst did not know about the content of the intervention. When prescribing the drug, the drug was given to the patient by the researcher for administration by mentioning the drug dosage and the method of administration. The outcome evaluator recorded the outcome based on the patient's identification number according to the randomization table, and the collected data was provided to the data analyst based on the number and mention of the intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemet Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2021-10-07, 1400/07/15
Ethics committee reference number
IR.IUMS.FMD.REC.1400.388
Health conditions studied
1
Description of health condition studied
Endometriosis and infertility
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Chemical pregnancy
Timepoint
Pregnancy check with beta hCG test two weeks after embryo transfer
Method of measurement
Beta hCG test
2
Description
Abortion
Timepoint
Continued pregnancy up to 20 weeks
Method of measurement
Examining the view of a live fetus with ultrasound
3
Description
Live birth
Timepoint
Pregnancy with a gestational age of more than 28 weeks
Method of measurement
Examining the live fetus with ultrasound
4
Description
Clinical pregnancy
Timepoint
Sonography 6 weeks later beta hCG positive
Method of measurement
Visualization of fetal heart rate by ultrasound
5
Description
Ongoing pregnancy
Timepoint
Continued pregnancy up to 12 weeks
Method of measurement
Ultrasound visualization of a live fetus at 12 weeks
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Infertile endometriosis patients and candidates for embryo transfer treated with Differlin 3.75 in three doses with an interval of one month and then 10 weeks later starting the first dose of Differlin treated with methylprednisolone 2.5 mg daily until the fetal heart is seen. In the ultrasound, the medicine is taken and then it is stopped little by little.
Category
Treatment - Drugs
2
Description
Control group: Infertile endometriosis patients and candidates for embryo transfer are treated with 3 doses of 3.75 mg Differlin ampoules every month for 3 months, and then they will undergo embryo transfer after receiving the third dose.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Department of Akbarabadi Hospital, Tehran
Full name of responsible person
Mona Mortezapur
Street address
Molavi Ave,shahid akbarabadi hospital
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Email
akbarisene.a@iums.ac.ir
Web page address
https://akbarabadihospital.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hosein keyvani
Street address
Hemat Highway, next to Milad Tower, Iran University of Medical Sciences, 5th floor
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2504
Email
azadehshiralizadeh96@gmail.com
Web page address
https://iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice President of Research and Technology of Iran 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
Iran University of Medical Sciences
Full name of responsible person
Azadeh Shiralizadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
35,17 Ershad,kuye naft,Ahwaz Town
City
Ahwaz
Province
Tehran
Postal code
6166663437
Phone
+98 61 3627 2597
Fax
Email
azadehshiralizadeh96@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Azadeh Shiralizadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
35,17 Ershad,kuye naft,Ahwaz Town
City
Ahwaz
Province
Tehran
Postal code
6166663437
Phone
+98 61 3627 2597
Fax
Email
azadehshiralizadeh96@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Azadeh Shiralizadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
35,17 Ershad,kuye naft,Ahwaz Town
City
Ahwaz
Province
Tehran
Postal code
6166663437
Phone
+98 61 3627 2597
Fax
Email
azadehshiralizadeh96@gmail.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