Evaluation of the safety and feasibility of intra ovarian injection of menstrual blood derived stem cells (MenSCs) in women with poor ovarian response.
Improvement of ovarian function and fertility in patients with poor ovarian response using stem cells derived from menstrual blood
Design
Clinical trial including control group, two arm parallel group, randomised trial
Settings and conduct
The entire population is selected according to the inclusion and exclusion criteria and all patients must sign the informed consent. The subjects are randomly divided into intervention and control groups. Menstrual blood is collected from the patients of the intervention group at days 1 or 2 of their menstruation cycle using menstrual cups. Stem cells are isolated from collected menstrual blood and cultured in vitro. Cultured cells are evaluated for phenotyping and non-contamination. Autologous cells are administered to the ovary of patients in Avicenna Infertility Treatment Center.
Participants/Inclusion and exclusion criteria
Inclusion criteria: married woman;having previous cycles of ovarian stimulation with oocyte number of up to 3;anti-muller hormone below 1.1 ng/ml; antral follicle below5; up to 40 years
Sperm analysis: 15 million per ml; normal morphology with the strict criterion of at least 2%;25% of sperm motility
Conditions of non compliance: Thyroid dysfunction; Immune system disease; History of cancer; Hepatitis B and C and HIV; Endometriosis; Ovarian surgery; Diabetes; Liver dysfunction
Intervention groups
Intervention group: patients with reduced ovarian function are treated by stem cell infusion
Control group: patients with reduced ovarian function are considered with no intervention only to compare their status with the intervention group
Main outcome variables
Number and volume of antral follicles
The amount of FSH and LH
AMH levels
Ovarian volume
Number of follicles in the treatment cycle
The number of oocytes in the treatment cycle
Quality of oocytes, the quality of the embryos
Occurrence of pregnancy
General information
Reason for update
Acronym
POR
IRCT registration information
IRCT registration number:IRCT20180619040147N2
Registration date:2018-08-21, 1397/05/30
Registration timing:registered_while_recruiting
Last update:2018-08-21, 1397/05/30
Update count:4
Registration date
2018-08-21, 1397/05/30
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
2018-08-06, 1397/05/15
Expected recruitment end date
2019-10-07, 1398/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the safety and feasibility of intra ovarian injection of menstrual blood derived stem cells (MenSCs) in women with poor ovarian response.
Public title
Evaluation of the safety and feasibility of intra ovarian injection of menstrual blood derived stem cells (MenSCs) in women with poor ovarian response.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Got married woman
Picked up less than 3 oocytes in last ovarian stimulation
Anti mullerian hormone; less than 1.1 ng/ml
Upper age limit: 40
Spermogram: more than 15 million/ml, normal morphology more than 2%, sperm motility (A+B) more than 25%
Anteral follicles: less than 5-7
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 25 years old to 40 years old
Gender
Female
Phase
N/A
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
2018-06-17, 1397/03/27
Ethics committee reference number
IR.ACECR.REC.1397.001
Health conditions studied
1
Description of health condition studied
Poor ovarian response
ICD-10 code
E89.40
ICD-10 code description
Asymptomatic postprocedural ovarian failure
Primary outcomes
1
Description
Number of antral follicles in ovary
Timepoint
Before intervention and 3 months, 6 months and one year after cell administration
Method of measurement
Vaginal sonography
2
Description
FSH level in blood serum
Timepoint
Before intervention and 3 months, 6 months and one year after cell administration
Method of measurement
Biochemical assay
3
Description
Anti Mullerian hormone level in blood serum
Timepoint
Before intervention and 3 months, 6 months and one year after cell administration
Method of measurement
biochemical assay
4
Description
number and quality of oocytes in ICSI cylcle
Timepoint
Before and 3-6 moths after intervention
Method of measurement
embryologic evaluation
5
Description
number and quality ofembryoes in ICSI cylcle
Timepoint
Before and 3-6 moths after intervention
Method of measurement
embryologic evaluation
Secondary outcomes
1
Description
Implantation rate
Timepoint
3,6 months and 1 year after intervention
Method of measurement
Vaginal sonography
2
Description
Clinical pregnancy
Timepoint
3,6 months and 1 year after intervention
Method of measurement
Vaginal sonography
3
Description
periodic cycle
Timepoint
Before and 3,6 months and 1 year after intervention
Method of measurement
Description of patient
Intervention groups
1
Description
Intervention group includes 15 patients with poor ovarian response that will be treated by stem cell injection.
Category
Treatment - Other
2
Description
Control group: includes 15 patients with poor ovarian response 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
Tehran
Province
Tehran
Postal code
1936773493
Phone
+98 21 23519
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, 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 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, 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