To investigate the efficacy of mesenchymal stem cell conditioned media (MSCs-CM) on modulate apoptotic and stress-related gene expression, ameliorate maturation and developmental potential of immature human oocytes after artificial activation in the infertile female.
Objective:
To investigate the efficacy of mesenchymal stem cell conditioned media (MSCs-CM) on modulate apoptotic and stress-related gene expression, ameliorate maturation and developmental potential of immature human oocytes after artificial activation in the infertile female.
Study design:
experimental, randomized clinical trial.
Inclusion criteria:
the age below 35 years old.
Exclusion criteria:
endometriosis; poly cystic ovarian syndrome; abnormal chromosome; low ovarian response; chronic anovulation and fewer than five oocytes in retrieval.
Method:
200 germinal vesicle (GV) oocytes from 100 patients who experienced an ICSI (Intracytoplasmic sperm injection) cycle randomly divided into 4 gropes, Intervention group 1:50 germinal vesicles will be used in α-minimal essential medium (α-MEM) and then into fresh (fIVM). Intervention group 2: 50 germinal vesicles will be used in α-minimal essential medium (α-MEM) and then into vitrification (vIVM(. Control group 1: 50 germinal vesicles will be used in MSCs-CM derived human umbilical cord and then into fresh (fIVM). Control group 2: 50 germinal vesicles will be used in MSCs-CM derived human umbilical cord and then into vitrification (vIVM). The expression of the BCL2, BAX, SOD and HSP70 genes will evaluate by Quantitative RT-PCR in IVM groups after oocytes maturation, which will be compared with control fresh and vitrified in-vivo maturity oocytes by stereo microscope for all four groups.
The developmental competence was evaluated after artificial activation by ionomycin 24 and 48 hours after insertion in the mediumin.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017101736840N1
Registration date:2017-11-11, 1396/08/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-11-11, 1396/08/20
Registrant information
Name
Hakimeh Akbari
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3322 1662
Email address
ghsuper@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research,Kerman University of Medical Sciences
Expected recruitment start date
2015-04-01, 1394/01/12
Expected recruitment end date
2016-04-01, 1395/01/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To investigate the efficacy of mesenchymal stem cell conditioned media (MSCs-CM) on modulate apoptotic and stress-related gene expression, ameliorate maturation and developmental potential of immature human oocytes after artificial activation in the infertile female.
Public title
To investigate the efficacy of mesenchymal stem cell conditioned media (MSCs-CM) on ameliorate maturation and developmental potential of immature human oocytes after artificial activation in the infertile female.
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria: the age lower than 35 years old.
Exclusion criteria: endometriosis; poly cystic ovarian syndrome; abnormal chromosome; low ovarian response; chronic anovulation and fewer than five oocytes on retrieval.
Age
To 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
N/A
Randomization description
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 Kerman University of Medical Sciences
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Kerman University of Medical Sciences, street
City
Kerman
Postal code
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
IR.KUM.REC.1393.692
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
Expression of the BCL2, BAX, SOD and HSP70 genes
Timepoint
after oocytes maturation
Method of measurement
by Quantitative RT-PCR
Secondary outcomes
1
Description
maturity of oocytes
Timepoint
24 and 48 hours after insertion in the medium
Method of measurement
by stereo microscope
2
Description
developmental competence
Timepoint
24 and 48 hours after insertion in the medium
Method of measurement
Ionomycin
Intervention groups
1
Description
Intervention group 1:50 germinal vesicles will be used in α-minimal essential medium (α-MEM) and then randomly be into fresh (fIVM).
Category
Treatment - Drugs
2
Description
Intervention group 2: 50 germinal vesicles will be used in α-minimal essential medium (α-MEM) and then randomly be into vitrification (vIVM).
Category
Treatment - Drugs
3
Description
Control group 1: 50 germinal vesicles will be used in MSCs-CM derived human umbilical cord and then randomly be into fresh (fIVM).
Category
Treatment - Drugs
4
Description
Control group 2: 50 germinal vesicles will be used in MSCs-CM derived human umbilical cord and then randomly be into vitrification (vIVM).
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour Infertility Center
Full name of responsible person
Hakime Akbari
Street address
next to Shahid Bahonar University, Imam Highway
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Kerman University of Medical Sciences
Full name of responsible person
Abbass Pardakhti
Street address
Beginning along the path of the seven Gardens of Olavi., Kerman University of Medical Sciences
City
Kerman
Grant name
این پروتکل در طرحی با نام " بررسی اثر محیط های پالایش شده بر فراساختار، تغییرات سلولی و مولکولی بلوغ تخمک های نابالغ انسانی منجمد شده به روش شیشه ای" ثبت و تایید اخلاقی دریافت کرده است
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hakime Akbari
Position
PhD in Anatomy
Other areas of specialty/work
Street address
Beginning along the path of the seven Gardens of Olavi., Kerman University of Medical Sciences
City
Kerman
Postal code
Phone
+98 34 3132 5700
Fax
Email
ghsuper@sums.ac.it
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman Universiy of Medical Sciences
Full name of responsible person
Seyed Hasan Eftekhar Vaghefi
Position
PhD in Anatomy
Other areas of specialty/work
Street address
Beginning along the path of the seven Gardens of Olavi, Kerman University of Medical Sciences
City
kerman
Postal code
Phone
+98 34 3132 5700
Fax
Email
sheftekharv@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
MS in english teaching ,BS in anesthesia/English Consultant
Other areas of specialty/work
Street address
5th floor, Mohammad Rasul Allah Research Tower, Khalili Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
masihifarzaneh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)