Effect of infertility treatment with and without addition of autologous platelet-rich plasma in embryo transfer in patients candidate for intra cytoplasmic sperm injection: a randomized clinical trial
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General information
2018-09-23, 1397/07/01
2022-09-23, 1401/07/01
20182022-09-23 00:00:00
2019-09-23, 1398/07/01
2023-09-23, 1402/07/01
20192023-09-23 00:00:00
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This study was implemented later than the time predicted in the project. The only place that needs to change is the start and end time of the study.
This study was implemented later than the time predicted in the project. The only place that needs to change is the start and end time of the study.
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این مطالعه دیرتر از زمان پیش بینی شده در پرووزال به اجرا درآمده است. لذا تنها جایی که نیاز دارد به روزرسانی صورت بگیرد زمان شروع و خاتمه مطالعه است.
این مطالعه دیرتر از زمان پیش بینی شده در پرووزال به اجرا درآمده است. لذا تنها جایی که نیاز دارد به روزرسانی صورت بگیرد زمان شروع و خاتمه مطالعه است.
Protocol summary
Study aim
To assess the effect of infertility treatment with and without addition of autologous platelet-rich plasma in embryo transfer in patients candidate for intra cytoplasmic sperm injection
Design
This is a randomized clinical trial, phase II, in which 56 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients candidate for intra cytoplasmic sperm injection who will refer to Fatemieh Hospital during the study period will be enrolled in the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 20 to 40 years;
Candidate for embryo transfer;
Having at least two embryos of good quality to transfer;
Having a healthy uterus cavity
Exclusion criteria:
Patients in need of sperm donation;
Patients in need of ovum donation;
Previous history of embryo transfer;
Endocrine diseases such as hyperthyroidism, hypothyroidism, hyperprolactinemia, diabetes
Intervention groups
Intervention group: Routine infertility treatment plus injection of autologous platelet-rich plasma 20% once
Control group: Just routine infertility treatment
This study was implemented later than the time predicted in the project. The only place that needs to change is the start and end time of the study.
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N230
Registration date:2018-08-24, 1397/06/02
Registration timing:prospective
Last update:2024-11-20, 1403/08/30
Update count:1
Registration date
2018-08-24, 1397/06/02
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of infertility treatment with and without addition of autologous platelet-rich plasma in embryo transfer in patients candidate for intra cytoplasmic sperm injection: a randomized clinical trial
Public title
Effect of infertility treatment with and without addition of autologous platelet-rich plasma in embryo transfer in patients candidate for intra cytoplasmic sperm injection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 20 to 40 years;
Candidate for embryo transfer;
Having at least two embryos of good quality to transfer;
Having a healthy uterus cavity
Exclusion criteria:
Patients in need of sperm donation;
Patients in need of ovum donation;
Previous history of embryo transfer;
Endocrine diseases such as hyperthyroidism, hypothyroidism, hyperprolactinemia, diabetes
Age
From 20 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2018-06-30, 1397/04/09
Ethics committee reference number
IR.UMSHA.REC.1397.235
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Chemical pregnancy
Timepoint
14 days after intervention
Method of measurement
Through laboratory test
2
Description
Clinical pregnancy
Timepoint
21 days after intervention
Method of measurement
By sonography
3
Description
Seeing fetal heart
Timepoint
28 days after intervention
Method of measurement
By sonography
Secondary outcomes
1
Description
Abortion
Timepoint
28 days after intervention
Method of measurement
Through history taking
Intervention groups
1
Description
Intervention group: Routine infertility treatment plus injection of autologous platelet-rich plasma 20% once
Category
Treatment - Drugs
2
Description
Control group: Just routine infertility treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Dr Fahimeh Salari Shahre Babaki
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
fahimesalarii67@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Fahimeh Salari Shahre Babaki
Position
Resident of Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
fahimesalarii67@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Marzieh Sanooei Farimani
Position
Gynecologist
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
dr_farimani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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