Protocol summary

Study aim
Effectiveness evaluation of intra-ovarian injection of autologous menstrual blood stem cells in fertility potential of patients with poor ovarian response
Design
Clinical trial including a control group, two-arm parallel-group, randomized 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 on day 2 of their menstruation cycle using menstrual cups. Stem cells are isolated from 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
married woman Picked up less than 3 oocytes in last ovarian stimulation Anti mullerian hormone; less than 1.1 ng/ml 25-45 years old Spermogram: more than 5 million/ml, normal morphology more than 1, sperm motility (A+B) more than 25% Anteral follicles: less than 5-7 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
Intervention groups
patients with reduced ovarian function are treated by stem cell infusion Control group: patients with reduced ovarian function under IVF treatment to compare their status with the intervention group
Main outcome variables
Number of antral follicles, Anti Mullerian hormone levels, Number and quality of oocytes in the treatment cycle, Number and quality of the embryos, Spontaneous pregnancy, Clinical pregnancy, Implantation rate, Live birth rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180619040147N4
Registration date: 2020-08-01, 1399/05/11
Registration timing: registered_while_recruiting

Last update: 2020-08-01, 1399/05/11
Update count: 0
Registration date
2020-08-01, 1399/05/11
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
recruiting
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2021-11-22, 1400/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness evaluation of intra-ovarian injection of autologous menstrual blood stem cells in fertility potential of patients with poor ovarian response: a controlled clinical trial study
Public title
Effectiveness evaluation of intra-ovarian injection of autologous menstrual blood stem cells in fertility potential of patients with poor ovarian response: a controlled clinical trial study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
married women ages between 25-45 years old Picked up equal or less than 3 oocytes in last ovarian stimulation Anti mullerian hormone; less than 1.1 nanogram per milliliter Anteral follicles: less than 5-7 Spermogram: more than 5 million per millilieter normal morphology more than 1%
Exclusion criteria:
un treated 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 renal failure disease history of blood trasfusion, anemia or sickle cell anemia
Age
From 25 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 180
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization: For this study, a specific population of unfertilized diminished ovarian reserve patients was chosen, admission and exclusion criteria from the study were chosen very detailed and accurate. all the population was all the same in the range of age and weight, non-fertility period, normal sperm analysis of their spouses, therefore block randomized of 180 patients were divided into main group (A), control group (B). hence 18 blocks of 10 were created using Computer logarithm from the study randomized app (https://app.studyrandomizer.com). All the blocks were the same and both groups contained the same amount of samples (1:1), the state of each block was different from the next block. randomizing the samples was conducted as follows: First, based on a computer logarithm 180 sample (patient) was randomized. and for each sample, block identifier, block size, sequence within the block was designed. For example, the code 2,6,1 shows that the second patient in block no. 1 of 10 is located in the second seat. for each patient, a specific code (study ID) was defined based on standard coding, and therefore the master randomized list was created for the patients.
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
Academic Center for Education, Culture and Research (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
2020-05-31, 1399/03/11
Ethics committee reference number
IR.ACECR.REC.1399.002

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, 3 months and 6 months after cell administration
Method of measurement
Vaginal sonography

2

Description
Anti Mullerian hormone level in blood serum
Timepoint
Before intervention, 3 months, 6 months and one year after cell administration
Method of measurement
biochemical assay

3

Description
number and quality of oocytes in intra-cytoplasmic sperm injection cycle
Timepoint
first intra-cytoplasmic sperm injection cycle after intervention
Method of measurement
embryologic evaluation

4

Description
spontaneous pregnancy
Timepoint
up to 3 months after intervention
Method of measurement
beta-HCG assay

Secondary outcomes

1

Description
Implantation rate
Timepoint
in new intra-cytoplasmic sperm injection cycle after intervention
Method of measurement
Vaginal sonography

2

Description
Clinical pregnancy
Timepoint
6-8 weeks after last menstrual period
Method of measurement
Vaginal sonography

3

Description
live birth
Timepoint
9 months after pregnancy
Method of measurement
delivery report based on gynecologist comment

4

Description
embryo quality and number
Timepoint
in new intra-cytoplasmic sperm injection cycle after intervention
Method of measurement
embryology report

Intervention groups

1

Description
Intervention group: includes 90 patients with poor ovarian response that will be treated by once injection of autologous menstrual blood stem cells. After cells isolation, culture and qualification in GMP grade- clean room of STERCO (Tehran, Iran), they will be intravaginally injected by vaginal ultrasonography into both ovaries of patients after receiving general anesthesia.
Category
Treatment - Other

2

Description
Control group: Iincludes 90 patients with poor ovarian response, being treated with IVF treatment cycles.
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
1983969412
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
Academic

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
Analytic Code
Not applicable
Data Dictionary
Not applicable
Loading...