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ّFeasibility evaluation of secretome obtained from menstrual blood derived stem cells accompanied with melatonin and follicular fluid in oocyte maturation of patients with polycystic ovary syndrome (PCOS).

Protocol summary

Study aim
Feasibility evaluation of secretome obtained from menstrual blood derived stem cells accompanied with melatonin and follicular fluid of non polycystic ovary syndrome patients in patients with polycystic ovary syndrome in order to improve oocyte maturation and assessment of embryos quality compared to control group.
Design
The clinical trial involves 4 groups including the control group plus 3 experimental groups in which the immature oocytes of 90 patients were non-randomly distributed.
Settings and conduct
The study will be performed at Avicenna Infertility Treatment Center on immature oocytes of polycystic ovary syndrome women. Immature oocytes in the germinal vesicle (GV) stage, which are not clinically usable, will be collected post ovulation of the patients who filled informed consent. Matured oocytes will be assessed for the expression of maturation-related genes and apoptotic genes using Polymerase Chain Reaction (PCR).
Participants/Inclusion and exclusion criteria
Among infertile women who visit the clinic: polycystic ovary syndrome women, ages under 40 yrs, Anti Mullerian hormone higher than 1.3, at least 4 immature oocytes and non male factor, are included. Non polycystic ovary syndrome women, unable to give informed consent, immature oocytes under 4, Anti Mullerian hormone under 1.3, background disease and infectious disease hepatitis C virus, human immunodeficiency virus (HIV) and hepatitis B, will be excluded.
Intervention groups
The study groups involve 4 groups for each individual containing the routine medium used for oocyte culture in the laboratory as a control, stem cell secretome, the secretome and melatonin, the secretome and melatonin and the follicular fluid added to the routine medium.
Main outcome variables
Oocyte maturation, embryo development, embryo quality, expression of oocyte maturation related genes and expression of apoptotic genes.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180619040147N8
Registration date: 2021-10-19, 1400/07/27
Registration timing: registered_while_recruiting

Last update: 2021-10-19, 1400/07/27
Update count: 0
Registration date
2021-10-19, 1400/07/27
Registrant information
Name
Maryam Darzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2020
Email address
m.darzi@ari.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-12, 1400/07/20
Expected recruitment end date
2022-05-20, 1401/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
ّFeasibility evaluation of secretome obtained from menstrual blood derived stem cells accompanied with melatonin and follicular fluid in oocyte maturation of patients with polycystic ovary syndrome (PCOS).
Public title
In Vitro Maturation of oocyte
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Polycystic ovary syndrome patients No background disease At least 4 immature oocyte Anti Mullerian hormone (AMH) higher than 1.3 No male factor
Exclusion criteria:
Unable to give informed consent Background disease Immature oocyte lower than 4 Infectious disease human immunodeficiency virus (HIV), hepatitis C virus (HCV) and Hepatitis B.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
More than 1 sample in each individual
Number of samples in each individual: 4
at least 4 immature oocytes from each patient will be enrolled in 4 groups.
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study for the first time, secretome obtained from menstrual blood derived stem cells accompanied with melatonin and follicular fluid of non poly cystic ovary syndrome patients in oocyte maturation will be evaluated.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in research of Avicenna Research Institute
Street address
Avicenna Research Institute, Shahid Beheshti University, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983969412
Approval date
2021-08-24, 1400/06/02
Ethics committee reference number
IR.ACECR.AVICENNA.REC.1400.013

Health conditions studied

1

Description of health condition studied
In Vitro Maturation of oocyte
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome

Primary outcomes

1

Description
Oocyte maturation
Timepoint
24 hours
Method of measurement
Detecting polar body under stereoscope

Secondary outcomes

1

Description
Embryo development after ICSI (Intra Cytoplasmic Sperm Injection)
Timepoint
24 and 48 hours after ICSI
Method of measurement
2PN and cell division assessment under stereoscope

2

Description
Embryo quality
Timepoint
48 and 72 hours after ICSI
Method of measurement
Embryo assessment under stereoscope

3

Description
Gene expression
Timepoint
24 hours after treatment
Method of measurement
PCR (Polymerase Chain Reaction)

Intervention groups

1

Description
Intervention group: Immature oocytes
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Avicenna Infertility Center
Full name of responsible person
Dr. Somaieh Kazemnejad
Street address
Yakhchal St. Shariati St.
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 21 23519
Email
info@avicennaclinic.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Mohammad-Reza Sadeghi
Street address
Avicenna Research Institute, Shahid Beheshti University, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1936772493
Phone
+98 21 2243 2020
Email
sadeghi@ari.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Grant given from Ministry of Science to Top researcher in 2020
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
Iranian academic center for education culture and research
Full name of responsible person
Hilda Rastegari
Position
Laboratory Expert
Latest degree
Master
Other areas of specialty/work
Microbiology
Street address
Shariati St.
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
22644755
Email
rastegari_h@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Somaieh Kazemnejad
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Avicenna Research Institute, Shahid Beheshti University, Evin, Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983969412
Phone
22432020
Email
s.kazemnejad@ari.ir

Person responsible for updating data

Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Somaieh Kazemnejad
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Avicenna Research Institute, Shahid Beheshti University, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1936773493
Phone
+98 21 2243 2020
Email
kazemnejad_s@yahoo.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
No - There is not 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
Not applicable
Data Dictionary
Not applicable
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