Effects of platelet derived growth factor on Invitro Fertilization (IVF) Failure
Design
The eligible patients are randomized (randomized by a statistician) to the two groups of patients (prescribe PRP (and control) without prescribing PRP). Assignment of samples (with or without growth factor) to patients Randomized random block method using Randomized permutation table (Random Block). Before PRP therapy and embryo transfer process, standard hormone replacement therapy (HRT) with Estradiol valerate was performed for all patients to endometrial thickness preparation. After sonographic assessment of endometrial thickness, PRP was injected to all patients whether they had appropriate endometrial thickness (7-10mm) or not (< 7mm). Intrauterine infusion of PRP was performed 48 h before embryo transfer in those who had appropriate endometrial thickness; while re-injections of PRP are needed for patients who had not an appropriate endometrial thickness. After sonographic reassessment, embryo transfer process was done through in vitro fertilization (IVF). Eventually, consequences of fertility, embryo implantation and pregnancy maintenance were evaluated.
Settings and conduct
The study will be conducted in Ahvaz Imam Khomeini hospital. The patients are randomized to the two groups of patients, prescribe PRP and without prescribing PRP.
Participants/Inclusion and exclusion criteria
Infertile Women: Under 40 y; Experienced at least one failure in the IVF process
Intervention groups
Intervention group: Before PRP therapy and embryo transfer process, standard hormone replacement therapy (HRT) with Estradiol valerate was performed for all patients to endometrial thickness preparation. After sonographic assessment of endometrial thickness, PRP was injected to all patients whether they had appropriate endometrial thickness or not . After sonographic reassessment, embryo transfer process was done through in vitro fertilization (IVF).
Control group: Before embryo transfer process, standard hormone replacement therapy (HRT) with Estradiol valerate was performed for all patients to endometrial thickness preparation. After sonographic reassessment, embryo transfer process was done through in vitro fertilization (IVF).
Main outcome variables
Embryo implantation
Pregnancy maintenance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180102038182N1
Registration date:2018-01-06, 1396/10/16
Registration timing:prospective
Last update:2018-01-06, 1396/10/16
Update count:0
Registration date
2018-01-06, 1396/10/16
Registrant information
Name
Mahvash Zargar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3221 6104
Email address
zargar-m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-07-21, 1397/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of platelet derived growth factor on Invitro Fertilization Failure
Public title
Platelet derived growth factor and IVF Failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women less than 40 years old
Infertile
At least one failure in the IVF process
Exclusion criteria:
Age
From 20 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted Block Randomization (Fourth block)
Blinding (investigator's opinion)
Single blinded
Blinding description
This is one blinded study. People who are evaluated, and data analyzer are unaware about the type of groups .
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی جندی شاپور اهواز
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2017-11-28, 1396/09/07
Ethics committee reference number
IR.AJUMS.REC.1396.634
Health conditions studied
1
Description of health condition studied
Infertile women
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Endometrial thickness
Timepoint
After prescribing estrogen and before administration PRP
Method of measurement
Sonography
Secondary outcomes
1
Description
Embryo implantation
Timepoint
After IVF
Method of measurement
Sonography
2
Description
Pregnancy maintenance
Timepoint
After IVF
Method of measurement
Sonography
Intervention groups
1
Description
Intervention group: Before PRP therapy and embryo transfer process, standard hormone replacement therapy (HRT) with Estradiol valerate was performed for all patients to endometrial thickness preparation. After sonographic assessment of endometrial thickness, PRP was injected to all patients whether they had appropriate endometrial thickness (7-10mm) or not (< 7mm). Intrauterine infusion of PRP was performed 48 h before embryo transfer in those who had appropriate endometrial thickness; while re-injections of PRP are needed for patients who had not an appropriate endometrial thickness. After sonographic reassessment, embryo transfer process was done through in vitro fertilization (IVF). Eventually, consequences of fertility, embryo implantation and pregnancy maintenance were evaluated.
Category
Treatment - Drugs
2
Description
Control group: Before embryo transfer process, standard hormone replacement therapy (HRT) with Estradiol valerate was performed for all patients to endometrial thickness preparation. After sonographic reassessment, embryo transfer process was done through in vitro fertilization (IVF). Eventually, consequences of fertility, embryo implantation and pregnancy maintenance were evaluated.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان امام خمینی (ره) اهواز
Full name of responsible person
مهوش زرگر
Street address
بیمارستان امام خمینی (ره)، بلوار آزادگان
City
Ahvaz
Province
Khouzestan
Postal code
1234587659
Phone
+98 61 3221 6104
Email
zargar-m@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
محمد بدوی
Street address
اهواز، گلستان، دانشگاه علوم پزشکی جندی شاپور اهواز
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3373 8383
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology of Ahvaz Jundishapur 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
Ahvaz University of Medical Sciences
Full name of responsible person
Razieh Pazhouhan far
Position
رزیدنت
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
بیمارستان امام خمینی، بلوار آزادگان
City
اهواز
Province
Khouzestan
Postal code
1234587659
Phone
+98 61 3221 6104
Email
razi59h@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahvash Zargar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Azadegan blv, Imam hospital
City
Ahvaz
Province
Khouzestan
Postal code
1234587659
Phone
+98 61 3221 6104
Fax
Email
zargar-m@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahvash Zargar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Azadegan blv, Imam hospital
City
Ahvaz
Province
Khouzestan
Postal code
1234587659
Phone
+98 61 3221 6104
Fax
Email
zargar-m@ajums.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