The effect of autologous conditioned serum on endometrial thickness and fertility rate of patients
Design
The clinical trial is without the control group, single, not blinded, non-randomized and quasi-experiment before-after design.
Settings and conduct
Blood samples will be collected at Valiasr Hospital in Tabriz, autologous conditioned serum will be provided and quality control will be provided. Then the autologous conditioned serum will be injected to the patients and after endometrial thickness reaches 7 mm they will have in vitro fertilization (IVF). Finally, the success of IVF and pregnancy will be assessed using beta-human chorionic gonadotropin (β-hCG) and sonography measurements.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women between the ages of 25-40 years, failed in vitro fertilization (IVF), having a history of infertility, endometrial thickness less than 7 mm
Exclusion criteria: having a normal pregnancy history and having no infertility problems, having a problem with infertility for reasons other than the inclusion criteria, people with malignancy, people with Asherman's Disease
Intervention groups
Women with inclusion criteria will be administered autologous conditioned serum on days 10–9 and 12–11 days and will be injected intrauterine.
Main outcome variables
The effect of autologous conditioned serum on endometrial thickness; The effect of autologous conditioned serum on fertility rate of patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160422027520N15
Registration date:2019-12-03, 1398/09/12
Registration timing:registered_while_recruiting
Last update:2019-12-03, 1398/09/12
Update count:0
Registration date
2019-12-03, 1398/09/12
Registrant information
Name
Mehdi Yousefi
Name of organization / entity
Department of Immunology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 4665
Email address
yousefime@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-06, 1398/08/15
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of autologous conditioned serum on endometrial thickness and fertility rate of patients
Public title
Increase endometrial thickness with autologous conditioned serum
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women between the ages of 25-40 years
Failed in vitro fertilization (IVF)
The availability of individual during the study period
Having a history of infertility
Endometrial thickness less than 7 mm
Exclusion criteria:
Having a financial incentive to participate in the study or Participate in another study simultaneously
Endometrial thickness more than 7 mm
People with malignancy
Previous delivery with cesarean section or having a normal pregnancy history
Having a history of curettage
Having pelvic inflammatory disease (PID)
History of radiotherapy at an in the past
People with Asherman's Disease
Age
From 25 years old to 40 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences , Daneshghah st, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2019-03-17, 1397/12/26
Ethics committee reference number
IR.TBZMED.REC.1397.1000
Health conditions studied
1
Description of health condition studied
Infertility due to low endometrial thickness
ICD-10 code
N80
ICD-10 code description
Endometriosis
Primary outcomes
1
Description
The effect of autologous conditioned serum on endometrial thickness
Timepoint
1 and 4 weeks after autologous conditioned serum injection
Method of measurement
Using sonography
Secondary outcomes
1
Description
The effect of processed autologous serum on fertility rate of patients
Timepoint
1, 4 and 12 weeks after in vitro fertilization (IVF)
Method of measurement
Using sonography and Serum beta-human chorionic gonadotropin (β-hCG) level assessment by enzyme-linked immunosorbent assay (ELISA) kit
Intervention groups
1
Description
Intervention group: The consumable material in this study is autologous conditioned serum (ACS) that is obtained by contacting a person's serum with glass beads in a sterile environment. The ACS is manufactured using Standard Kit Company's kits. This is an Iranian company. This product contains growth factors and anti-inflammatory cytokine and will be injected autologously. 10 patients with a history of infertility with less than 7 mm in endometrial thickness will be selected and, after obtaning informed consent, will be referred to the Vali-e-Asr Hospital for autologous conditioned serum injection.Endometrial thickness will be assessed 1 and 4 weeks after preparation and intrauterine injection of autologous conditioned serum (on days 9-10 and 12-12). in vitro fertilization (IVF) will be performed If the endometrial thickness exceeds 7 mm. Pregnancy of patients up to 12 weeks is monitored by sonography and serum beta-human chorionic gonadotropin (β-hCG) level.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali-e-asr Hospital, Tabriz
Full name of responsible person
Mehdi Yousefi
Street address
Vali-e-asr Hospital, El-Goli
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7767
Email
mehdi_yusefi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Yousefi
Street address
Tabriz University of Medical Sciences, Golgasht Avenue,Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4665
Email
yousefime@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Yousefi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Tabriz University of Medical Sciences, Golgasht Avenue,Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4665
Email
yousefime@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Yousefi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Tabriz University of Medical Sciences, Golgasht Avenue,Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4665
Email
yousefime@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Yousefi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Tabriz University of Medical Sciences, Golgasht Avenue,Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4665
Email
yousefime@tbzmed.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