Investigating the effect of early medical treatment with enoxaparin on the rate of successful fertility following assisted reproductive methods in comparison to assisted reproductive methods without early use of enoxaparin in Kamali Medical Education Center in 1402-1401
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General information
80
90
8090
empty
According to Professor Emar, the number of people participating in the study increased from 80 to 90.
According to Professor Emar, the number of people participating in the study increased from 80 to 90.
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با توجه به نظر استاد امار تعداد افراد شرکت کننده در مطالعه از 80 نفر به 90 نفر افزایش پیدا کرد
با توجه به نظر استاد امار تعداد افراد شرکت کننده در مطالعه از 80 نفر به 90 نفر افزایش پیدا کرد
Our sample size is 80 people, with 40people in each group. Block randomization method was designed by epidemiologist using STATA version 13 software. Unit of randomization such is individual. The number of blocks considered is 4.
Our sample size is 90 people, with 45people in each group. Block randomization method was designed by epidemiologist using STATA version 13 software. Unit of randomization such is individual. The number of blocks considered is 4.
Our sample size is 8090 people, with 40people45people in each group. Block randomization method was designed by epidemiologist using STATA version 13 software. Unit of randomization such is individual. The number of blocks considered is 4.
حجم نمونه ما 80نفر میباشد که 40نفر در هر گروه قرار خواهند گرفت. روش تخصیص تصادفی بلوکی ، به صورت فردی بوده که با استفاده از نرم افزار stata ورژن 13 توسط همکار اپیدمیولوژیست طراحی شد عداد بلوک های در نظر گرفته شده 4 تایی است.
حجم نمونه ما 90 نفرمیباشد که 45نفر در هر گروه قرار خواهند گرفت. روش تخصیص تصادفی بلوکی ، به صورت فردی بوده که با استفاده از نرم افزار stata ورژن 13 توسط همکار اپیدمیولوژیست طراحی شد عداد بلوک های در نظر گرفته شده 4 تایی است.
حجم نمونه ما 80نفر میباشد90 نفرمیباشد که 40نفر45نفر در هر گروه قرار خواهند گرفت. روش تخصیص تصادفی بلوکی ، به صورت فردی بوده که با استفاده از نرم افزار stata ورژن 13 توسط همکار اپیدمیولوژیست طراحی شد عداد بلوک های در نظر گرفته شده 4 تایی است.
80 cards containing sequences of treatments will be written and a10-digit random code, as the patient’s identification number, will be provided for each packet. When the researcher announces the eligibility of a patient, the methodologist will provide the researcher with the envelope. The person evaluating the outcomes is a third person who is unaware of the random allocation process and type of treatment. Data analysis will be carried out by a statistician who is aware of all the processes performed.the participants are aware of the type of intervention
90 cards containing sequences of treatments will be written and a10-digit random code, as the patient’s identification number, will be provided for each packet. When the researcher announces the eligibility of a patient, the methodologist will provide the researcher with the envelope. The person evaluating the outcomes is a third person who is unaware of the random allocation process and type of treatment. Data analysis will be carried out by a statistician who is aware of all the processes performed.the participants are aware of the type of intervention
8090 cards containing sequences of treatments will be written and a10-digit random code, as the patient’s identification number, will be provided for each packet. When the researcher announces the eligibility of a patient, the methodologist will provide the researcher with the envelope. The person evaluating the outcomes is a third person who is unaware of the random allocation process and type of treatment. Data analysis will be carried out by a statistician who is aware of all the processes performed.the participants are aware of the type of intervention
جهت پنهان سازی فرایند تخصیص تصادفی، بر روی 80کارت توالی درمانها به ترتیب نوشته خواهد شد سپس کارت ها در درون پاکت های نامه مهر و موم شده گذاشته میشود. بر روی هر پاکت کد 10 رقمی تصادفی بدون ترتیب و چارچوبی نوشته میشود که شماره شناسایی بیمار مربوطه . هنگامیکه محقق واجد شرایط بودن یک بیمار را اعلام میکند متدولوژیست طرح پاکت نامه را در اختیار محقق قرار خواهد داد و مداخله مورد نظر براساس نوع ذکر شده در پاکت نامه انتخاب میشود. فرد ارزیابی کننده پیامدهای مورد نظر شخص سومی است که از فرایند تخصیص تصادفی و نوع درمان انجام شده بیخبر است. آنالیز دادهها توسط یک متخصص آمار که از تمامی فرایندهای انجام شده بیخبر است انجام خواهد شد. شرکت کنندگان از نوع مداخله اگاه هستند
جهت پنهان سازی فرایند تخصیص تصادفی، بر روی 90کارت توالی درمانها به ترتیب نوشته خواهد شد سپس کارت ها در درون پاکت های نامه مهر و موم شده گذاشته میشود. بر روی هر پاکت کد 10 رقمی تصادفی بدون ترتیب و چارچوبی نوشته میشود که شماره شناسایی بیمار مربوطه . هنگامیکه محقق واجد شرایط بودن یک بیمار را اعلام میکند متدولوژیست طرح پاکت نامه را در اختیار محقق قرار خواهد داد و مداخله مورد نظر براساس نوع ذکر شده در پاکت نامه انتخاب میشود. فرد ارزیابی کننده پیامدهای مورد نظر شخص سومی است که از فرایند تخصیص تصادفی و نوع درمان انجام شده بیخبر است. آنالیز دادهها توسط یک متخصص آمار که از تمامی فرایندهای انجام شده بیخبر است انجام خواهد شد. شرکت کنندگان از نوع مداخله اگاه هستند
جهت پنهان سازی فرایند تخصیص تصادفی، بر روی 80کارت90کارت توالی درمانها به ترتیب نوشته خواهد شد سپس کارت ها در درون پاکت های نامه مهر و موم شده گذاشته میشود. بر روی هر پاکت کد 10 رقمی تصادفی بدون ترتیب و چارچوبی نوشته میشود که شماره شناسایی بیمار مربوطه . هنگامیکه محقق واجد شرایط بودن یک بیمار را اعلام میکند متدولوژیست طرح پاکت نامه را در اختیار محقق قرار خواهد داد و مداخله مورد نظر براساس نوع ذکر شده در پاکت نامه انتخاب میشود. فرد ارزیابی کننده پیامدهای مورد نظر شخص سومی است که از فرایند تخصیص تصادفی و نوع درمان انجام شده بیخبر است. آنالیز دادهها توسط یک متخصص آمار که از تمامی فرایندهای انجام شده بیخبر است انجام خواهد شد. شرکت کنندگان از نوع مداخله اگاه هستند
Protocol summary
Study aim
Investigating the effect of early medical treatment with enoxaparin on the rate of successful fertility following assisted reproductive methods in comparison to assisted reproductive methods without early use of enoxaparin in Kamali Medical Education Center in 1402-1401
Design
Clinical trial with a control group, with parallel groups, single-blind, randomized, phase 3 on 80 patients. For randomization, the block randomization method will be used using: www.sealedenvelope.com
Settings and conduct
This study will be done at Kamali hospital in karaj city. Patients underwent IVF at the time of embryo transfer is given subcutaneous enoxaparin . No intervention is performed for the control group. And the rate of chemical pregnancy, clinical pregnancy and Abortion were compared between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 20-40 years, BMI body mass index between 18-30, Having an egg suitable for fertilization, Having a suitable endometrium with a diameter greater than 7 mm.
Exclusion criteria
Not having a specific medical disease that affects the study, Not taking enoxaparin chronically before the study for any reason, Not having a specific coagulation disease such as platelet deficiency, History of previous abortion, History of successful pregnancy.
Intervention groups
Control group: There is no intervention. Intervention group: patients undergoing ART at the time of embryo transfer is given subcutaneous enoxaparin at a dose of 1 mg/kg/day/sc, which continues for about two weeks later.
Main outcome variables
chemical pregnancy and clinical pregnancy
General information
Reason for update
According to Professor Emar, the number of people participating in the study increased from 80 to 90.
Acronym
IRCT registration information
IRCT registration number:IRCT20220530055028N1
Registration date:2023-01-30, 1401/11/10
Registration timing:prospective
Last update:2025-09-01, 1404/06/10
Update count:1
Registration date
2023-01-30, 1401/11/10
Registrant information
Name
Mehrnaz Raeisidehkordi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3446 0708
Email address
mraeisi283@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-11, 1401/12/20
Expected recruitment end date
2024-01-10, 1402/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of early medical treatment with enoxaparin on the rate of successful fertility following assisted reproductive methods in comparison to assisted reproductive methods without early use of enoxaparin in Kamali Medical Education Center in 1402-1401
Public title
Investigating the effect of early medical treatment with enoxaparin on the rate of successful fertility following assisted reproductive methods
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20-40 years
BMI body mass index between 18-30
Having an egg suitable for fertilization
Having a suitable endometrium with a diameter greater than 7 mm
Exclusion criteria:
Not having a specific medical disease that affects the study.
Not taking enoxaparin chronically before the study for any reason
Not having a specific coagulation disease such as platelet deficiency
History of previous abortion
History of successful pregnancy
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Our sample size is 90 people, with 45people in each group. Block randomization method was designed by epidemiologist using STATA version 13 software. Unit of randomization such is individual. The number of blocks considered is 4.
Blinding (investigator's opinion)
Single blinded
Blinding description
90 cards containing sequences of treatments will be written and a10-digit random code, as the patient’s identification number, will be provided for each packet. When the researcher announces the eligibility of a patient, the methodologist will provide the researcher with the envelope. The person evaluating the outcomes is a third person who is unaware of the random allocation process and type of treatment. Data analysis will be carried out by a statistician who is aware of all the processes performed.the participants are aware of the type of intervention
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
Ethics committee unit; Vice Chancellor for Research; No.20; Saffarian alley; 45 Metri Golshahr street
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2022-12-03, 1401/09/12
Ethics committee reference number
IR.ABZUMS.REC.1401.258
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Chemical pregnancy
Timepoint
14 days after embryo transfer
Method of measurement
Serum BhCG level
2
Description
Clinical pregnancy
Timepoint
5 weeks after transfer
Method of measurement
Sonography
Secondary outcomes
1
Description
Abortion
Timepoint
Before the 20th week of pregnancy
Method of measurement
Sonography
Intervention groups
1
Description
Intervention group: The intervention group of patients undergoing ART at the time of embryo transfer is given subcutaneous enoxaparin at a dose of 1 mg/kg/day/sc, which continues for about two weeks later.
Category
Treatment - Drugs
2
Description
Control group: There is no intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kamali hospital
Full name of responsible person
Mehrnaz Raeisidehkordi
Street address
Kamali hospital; Kamali alley; Shohada square; Shahid Beheshti street
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3222 2021
Email
mraeisi283@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mohammad Nourisepehr
Street address
Vice Chancellor for Research; No.20; Saffarian alley; 45 Metri Golshahr street
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
Research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Mehrnaz Raeisidehkordi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Gohardasht
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3446 0708
Fax
Email
mraeisi283@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mehrnaz Raeisidehkordi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Gohardasht
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3446 0708
Fax
Email
mraeisi283@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mehrnaz Raeisidehkordi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Gohardasht
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3446 0708
Fax
Email
mraeisi283@gmail.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