Investigating the effect of adipose-derived stem cells on premature menopause as an autologous allogeneic in phase 1 and 2 clinical trial.
Design
Clinical trial with a control group, with parallel groups, three-way blind, randomized, phase 1 on 90 patients. The rand function of Excel software was used for randomization.
Settings and conduct
Arash Women's General Hospital, Iran University of Medical Sciences
Blinding was performed by the personnel of the infertility clinic of Arash Women's Hospital.
Participants/Inclusion and exclusion criteria
Women between 18-38 years old
Having premature menopause syndrome
Amenorrhea that lasts 4-6 months in combination
Increased follicle stimulating hormone (FSH > 20 IU/l)
Reduction of estradiol level achieved after one month (> 20 IU/l)
Low Anti-Müllerian Hormone (AMH) levels - < 0.5 ng/ml (< 1 ng/ml)
No use of hormonal drugs until the last three months
Absence or history of malignancies
No endometriosis
Not having polycystic ovary syndrome
Intervention groups
The first group receives autologous cells
The second group receives allogeneic cells
The third group is the control group that receives its routine treatment.
Main outcome variables
Amount of cells obtained for injection
General health of patients
How to respond to treatment
General information
Reason for update
Acronym
POF
IRCT registration information
IRCT registration number:IRCT20240815062771N1
Registration date:2024-11-15, 1403/08/25
Registration timing:registered_while_recruiting
Last update:2024-11-15, 1403/08/25
Update count:0
Registration date
2024-11-15, 1403/08/25
Registrant information
Name
shahrzad zhaeentan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4486 8791
Email address
zhaeentan.shahrzad@yahoo.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-10-22, 1403/08/01
Expected recruitment end date
2025-10-23, 1404/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Allo/Autolog adipose derived mesenchymal stem cells in premature ovarian failure(POF) 1and 2clinical trail phases
Public title
The effect of stem cells therapy in premature ovarian failure(POF)
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Women between 18-38years old with premature ovarian failure(POF)
low anti-Müllerian hormone (AMH) levels – < 0.5 ng/ml (< 1 ng/ml)
amenorrhea lasting 4-6 months in combination
elevated follicle-stimulating hormone (FSH > 20 IU/l)
decreased estradiol levels obtained one month apart(< 20 pg/ml)
Exclusion criteria:
Endometriosis
Having a history of malignancy
polycystic ovary syndrome (PCOS)
Age
From 18 years old to 38 years old
Gender
Female
Phase
1
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
90
More than 1 sample in each individual
Number of samples in each individual:
4
Blood samples are taken from patients in 3 stages. One time before the injection of cells, one time 24 hours after the injection and the next time 6 months after the injection. Mesenchyme stem cells derived from adipose tissue as allogeneic and autologous.
Randomization (investigator's opinion)
Randomized
Randomization description
It is done using the blocking method. In total, all patients are divided into 30 blocks of 3, in each block one person is selected for autologous injection, one person is selected for allogeneic injection, and one person is selected as a control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the researcher, the patient and the people who analyze the data are blinded
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committees of Iran University of Medical Science
Street address
Hemat Highway, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2022-07-02, 1401/04/11
Ethics committee reference number
IR.IUMS.REC.1401.295
Health conditions studied
1
Description of health condition studied
Premature ovarian failure (POF)
ICD-10 code
E28.3
ICD-10 code description
Primary ovarian failure
Primary outcomes
1
Description
Adipose-derived stem cells
Timepoint
before the injection of cells
Method of measurement
Cell count
2
Description
AMH
Timepoint
Before injection of cells, 24 hours after injection, 6 months after injection
Method of measurement
Enzyme-Linked Immunosorbent Assay
3
Description
LH
Timepoint
Before injection of cells, 24 hours after injection, 6 months after injection
Method of measurement
Enzyme-Linked Immunosorbent Assay
4
Description
AFC
Timepoint
Before injection of cells, 6 months after injection
Method of measurement
sonography
5
Description
MFC
Timepoint
Before injecting the cells, monthly for up to 6 months after the injection
Method of measurement
sonography
6
Description
IL6
Timepoint
Before injection of cells, 24 hours after injection, 6 months after injection
Method of measurement
Enzyme-Linked Immunosorbent Assay
7
Description
TNF alpha
Timepoint
Before injection of cells, 24 hours after injection, 6 months after injection
Method of measurement
Enzyme-Linked Immunosorbent Assay
8
Description
Pregnancy rate
Timepoint
14 days after embryo transfer
Method of measurement
Beta HCG blood test
9
Description
E2
Timepoint
Before injection of cells, 24 hours after injection, 6 months after injection
Method of measurement
Enzyme-Linked Immunosorbent Assay
10
Description
FSH
Timepoint
Before injection of cells, 24 hours after injection, 6 months after injection
Method of measurement
Enzyme-Linked Immunosorbent Assay
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group receiving autologous cells
Category
Treatment - Other
2
Description
Intervention group: They receive allogeneic cells
Category
Treatment - Other
3
Description
Control group: They receive their routine treatment