Assessment of safety and effectiveness of intrauterine infusion of allogeneic menstrual blood stem cells in women with unexplained recurrent pregnancy loss: A double-blind phase 1 and 2 clinical trial
Assessment of safety and effectiveness of intrauterine infusion of allogeneic menstrual blood stem cells in patients with unexplained recurrent pregnancy loss
Design
A randomized, double-blind, sham-controlled phase 1&2 clinical trial with forty patients, followed for one year
Settings and conduct
Recurrent pregnancy loss is one of the common disorders of pregnancy. In this clinical trial, effect of intrauterine infusion of allogeneic decidualized menstrual blood stem cells in women with unexplained recurrent pregnancy loss will be assessed. In this project, which is conducted in Avicenna infertility clinic, 40 women with recurrent pregnancy loss will randomly be divided into two groups of 20. Women in treatment group will receive intrauterine infusion of allogeneic decidualized menstrual blood stem cells, while in control women intrauterine sterile PBS buffer will be infused. Menstrual blood stem cells will be obtained from AIC stem cell bank. Cells will be decidualized in vitro for 6 days. Participants and clinicians are not aware of intervention type
Participants/Inclusion and exclusion criteria
In this project, women with recurrent pregnancy loss are recruited. Women with past history of pregnancy are not recruited.
Intervention groups
Forty women with unexplained recurrent pregnancy loss are randomly divided into two groups of 20 (treatment and control). Women in treatment group will receive intrauterine infusion of allogeneic decidualized menstrual blood stem cells, while in control women intrauterine sterile PBS buffer will be infused
Main outcome variables
Side effects of intrauterine infusion of allogeneic decidualized menstrual blood stem cells, percent of abortion, percent of clinical pregnancy, live birth rate, frequency of twins birth, weight of newborn
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210513051280N2
Registration date:2021-05-31, 1400/03/10
Registration timing:prospective
Last update:2021-05-31, 1400/03/10
Update count:0
Registration date
2021-05-31, 1400/03/10
Registrant information
Name
AMIR-HASSAN ZARNANI
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2020
Email address
zarnania@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-21, 1400/04/30
Expected recruitment end date
2022-02-19, 1400/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of safety and effectiveness of intrauterine infusion of allogeneic menstrual blood stem cells in women with unexplained recurrent pregnancy loss: A double-blind phase 1 and 2 clinical trial
Public title
Evaluation of the effect of menstrual blood stem cells in recurrent pregnancy loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with primary recurrent pregnancy losses (at least two successive pregnancy losses excluding blighted ovum confirmed by sonography or pathology till 10th week of gestation
Maximum patient age: 37 years, no history of previous live birth
FSH level of less than 10 mIU/mL
Negative test results for HIV, HBS Ag, HCV and VDRL
Exclusion criteria:
Having previous history of successful pregnancy
Chromosomal abnormalities in parents
Uterine anatomic abnormalities
Hormonal abnormalities
PCO with metabolic syndrome
Uncontrolled diabetes
Stage 3 or 4 endometriosis
Autoimmune diseases including rheumatoid arthritis, thyroid autoimmunity, lupus and anti-phospholipid antibodies
History of cancer, chemotherapy and radiotherapy
Spermogram abnormalities (DFI more than 30 and normal sperm morphology less than 2%
History of immunosuppressive drugs intake including corticosteroids during the past three months
Age
From 20 years old to 37 years old
Gender
Female
Phase
1-2
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization: In order to randomly assign 40 subjects in treatment group or control group, 10 blocks including 4 subjects each will be defined using "https://app.studyrandomizer.com". Blocks are small and balanced with predetermined group assignments, which keeps the numbers of subjects in each group similar at all times. Treatment group and control group will be identified by codes A and B, respectively. In each block, number of treatment group and control group is equal with assigning ratio of 1:1.
Blinding (investigator's opinion)
Double blinded
Blinding description
Neither participants nor clinical care or analyzers are aware of the type of intervention
Placebo
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
No.1270, Secretariat of the Ethics Committee of ACECR, Deputy of Research and Technology, Headquarter of ACECR, Opposite the main door of Tehran University, Enghelab street, Tehran
City
Tehran
Province
Tehran
Postal code
4364 - 14155
Approval date
2021-03-15, 1399/12/25
Ethics committee reference number
IR.ACECR.REC.1399.007
Health conditions studied
1
Description of health condition studied
Recurrent pregnancy loss
ICD-10 code
XV
ICD-10 code description
Pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Pregnancy loss
Timepoint
Before 20th week of gestation
Method of measurement
Sonography
Secondary outcomes
1
Description
Clinical pregnancy rate
Timepoint
6th week of pregnancy
Method of measurement
Sonography
2
Description
Live birth rate
Timepoint
At the end of pregnancy period
Method of measurement
Delivery
3
Description
Twin pregnancy
Timepoint
6th week of gestation
Method of measurement
Sonography
4
Description
Newborn weight
Timepoint
After delivery
Method of measurement
Weighting
Intervention groups
1
Description
Intervention group: A single dose of intrauterine infusion of allogeneic decidualized menstrual blood stem cells with final volume of 0.5 ml containing 1 million cells.
Category
Treatment - Other
2
Description
Control group: A single dose of intrauterine infusion of sterile phosphate buffer
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Avicenna Infertility Clinic
Full name of responsible person
Amir-Hassan Zarnani
Street address
No. 97, Beginning of Yakhchal St., Shariati Ave. Tehran
City
Tehran
Province
Tehran
Postal code
1998887621
Phone
+98 21 23519
Email
info@avicennaclinic.ir
Web page address
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, Opposite to Faculty of Computer, Shahid Beheshti University, Evin, Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
2122432020
Phone
+98 21 2243 2020
Email
info@avicenna.ac.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
Private
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
Amir-Hassan Zarnani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Avicenna Research Institute, Opposite to Faculty of Computer, Shahid Beheshti University, Evin, Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
2122432020
Phone
+98 21 2243 2020
Fax
Email
zarnania@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Amirhossein Zarnani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Avicenna Research Institute, Opposite to Faculty of Computer, Shahid Beheshti University, Evin, Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
2122432020
Phone
+98 21 2243 2020
Email
zarnania@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Amirhossein Zarnani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Avicenna Research Institute, Opposite to Faculty of Computer, Shahid Beheshti University, Evin, Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
2122432020
Phone
+98 21 2243 2020
Email
zarnania@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Protocol and the results of primary and secondary consequences
When the data will become available and for how long
After patent registry
To whom data/document is available
Investigators of universities and research institutes
Under which criteria data/document could be used
Research use
From where data/document is obtainable
Avicenna Research Institute, Amir-Hassan Zarnani
What processes are involved for a request to access data/document
Formal written request to Avicenna Research Institute Chancellor