Evaluation of the safety and feasibility of infra ovarian injection of menstrual blood derived stem cells (MenSCs) in women with premature ovarian failure
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Ethics committees
#1
2018-06-17, 1397/03/27
2018-05-06, 1397/02/16
2018-05-06-17 00:00:00
Protocol summary
Study aim
Increased ovarian function and fertility in early menopausal patients (POF) using stem cells derived from menstrual blood
Design
The study will be done as clinical trail such the ovarian function of POF patients after cell therapy using menstrual blood stem cells in case group will be compared to that of control group without intervention. The selection will be done as nonrandomized. The number of patients in each group will be 15.
Settings and conduct
The eligible patients will study and sign the inform consent. After randomization these women will be divided into case or control group and the phases 1 and 2 of clinical trial will be started. The menstrual blood will be collected using divacup at day 1 or 2 of menstruation and stem cells will be
isolated cultured and assessed in aspect of phenotype and no contamination in clean room of Avicenna Research Institute. The autologous cultured cells will be administrated into ovary of
patients in Avicenna infertility Clinic.
Participants/Inclusion and exclusion criteria
1 - married woman 2 - over 20 and under 40 years 3 - normal karyotype 4 - premature ovarian failure and the amount of follicle stimulating hormone greater than 20 IU / ml and anti-muller hormone below 1 ng / ml 5-sperm analysis at least 15 million per ml Sperm and normal morphology 2% and spermatozoa (A + B) above 25%
Intervention groups
1-Thyroid deficiency 2- Immune system disease 3- Cancer history and chemotherapy and radiation therapy 4. Hepatitis B and C virus infection and HIV 5- Endometriosis Severe 6. History of ovarian surgery 7- Diabetes 8. Test disorder Electrolyte or liver
Main outcome variables
number and size of anteral follicles, FSH and LH levels, Anti Mullerian hormone (ATH) level, ovary size, menstruation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180619040147N1
Registration date:2018-08-20, 1397/05/29
Registration timing:registered_while_recruiting
Last update:2019-06-16, 1398/03/26
Update count:2
Registration date
2018-08-20, 1397/05/29
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
2018-07-11, 1397/04/20
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the safety and feasibility of infra ovarian injection of menstrual blood derived stem cells (MenSCs) in women with premature ovarian failure
Public title
Evaluation of the safety and feasibility of infra ovarian injection of menstrual blood derived stem cells (MenSCs) in women with premature ovarian failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
got married woman
normal karyotype
FSH more than 20 IU/ml
anti mullerian hormone; less than 1 ng/ml
spermogram: more than 15 million/ml, normal morphology more than 2%, sperm motility (A+B) morethan 25%anteral follicles: less than 5
Exclusion criteria:
thyroid dysfunction
immune disorders
history of cancer, chemotherapy and radiotherapy
infected by hepatitis B,C or HIV
severe endometriosis
history of ovarian surgery
diabetes
dysfunction of electrolyte or liver tests
psychological problem like depression, high stress an anxiety
Age
From 20 years old to 40 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
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
ACECR Biomedical Research Ethics Committee
Street address
1270, Secretariat of the Ethics Committee of ACECR,Deputy Director of Research and Technology, Headquarters of ACECR, Opposite the main door of Tehran University, Enghelab Street, Tehran
City
Tehran
Province
Tehran
Postal code
1936773493
Approval date
2018-05-06, 1397/02/16
Ethics committee reference number
IR.ACECR.REC.1397.001
Health conditions studied
1
Description of health condition studied
premature ovarian failure
ICD-10 code
E28.31
ICD-10 code description
Premature menopause
Primary outcomes
1
Description
number and diameter of anteral follicles, FSH level, AMH level, ovary volume, menstruation
Timepoint
3 months, 6 months and one year after cell administration
Intervention group includes 15 patients with premature ovarian failure that will be treated by stem cell injection.
Category
Treatment - Other
2
Description
Control group: includes 15 patients with premature ovarian failure that will not receive any intervention and their biochemical parameters, sonographic and embryologic data will be compared with intervention group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Avicenna Infertility Clinic
Full name of responsible person
Somaieh Kazemnejad
Street address
No 97, Beginning of Yakhchal Street, Shariati Ave.
City
Thran
Province
Tehran
Postal code
1936773493
Phone
+98 21 2243 2020
Email
kazemnejad_s@yahoo.com
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?
Yes
Title of funding source
Iranian academic center for education culture and research
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
Other
Person responsible for general 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 for Biological Sciences, Shahid Beheshti University, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1936773493
Phone
+98 22432020
Email
kazemnejad_s@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, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1936773493
Phone
+98 21 2243 2020
Email
kazemnejad_s@yahoo.com
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 for Biological Sciences, 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