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A clinical trial investigating the safety and efficacy of intraovarian injection of menstrual blood stem cell-derived exosome (MenSc-EV) in the fertility response of patients with poor ovarian response

Protocol summary

Study aim
Improvement of ovarian function and fertility in patients with poor ovarian response using allogenic menstrual blood stem cells-derived exosome
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 healthy donors. Cultured stem cells are evaluated for phenotyping and non-contamination. Exosomes are extracted from condition media and after confirmation of quality control tests, allogenic exosomes are administered to the ovary of patients in the intervention group in the Avicenna Infertility Treatment Center.
Participants/Inclusion and exclusion criteria
Inclusion criteria: married woman, Picked up less than 3 oocytes in last ovarian stimulation, Anti Mullerian hormone less than1.1 ng/ml, Antral follicles: less than 5-7, below 40 years old, Spermogram: more than 5 million/ml, normal morphology more than 1, sperm motility more than 25%, 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 liver tests
Intervention groups
Intervention group: POR patients are treated with stem cell-derived exosome infusion Control group: POR patients are considered with no intervention only to compare their status with the intervention group
Main outcome variables
Evaluation of safety and reactivity of allogeneic exosome injection, Number of antral follicles, Anti-Mullerian hormone levels, No and quality of oocytes in the treatment cycle, Number and quality of the embryos, Spontaneous pregnancy, Clinical pregnancy and Implantation rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240814062753N1
Registration date: 2025-02-06, 1403/11/18
Registration timing: prospective

Last update: 2025-02-06, 1403/11/18
Update count: 0
Registration date
2025-02-06, 1403/11/18
Registrant information
Name
Mina Fathi Kazerooni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2020
Email address
m.fathi@avicenna.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-05-05, 1404/02/15
Expected recruitment end date
2025-11-06, 1404/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial investigating the safety and efficacy of intraovarian injection of menstrual blood stem cell-derived exosome (MenSc-EV) in the fertility response of patients with poor ovarian response
Public title
Menstrual blood stem cell-derived exosome in the treatment of infertility
Purpose
Treatment
Inclusion/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 below 5 Up to 40 years Sperm analysis: more than 5 million per ml; normal morphology with strict criterion of at least 1%;25% of sperm motility
Exclusion criteria:
Thyroid dysfunction Immune system disease History of cancer Hepatitis B and C and HIV Endometriosis Ovarian surgery Diabetes Liver dysfunction Kidney dysfunction Severe anemia
Age
To 40 years old
Gender
Female
Phase
1-2
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization: To randomly assign 30 subjects in the treatment group or control group, 5 blocks, each with 6 subjects, will be defined using "https://app.studyrandomizer.com." The treatment group and control group will be identified by codes A and B, respectively. In each block, the number of treatment groups and control groups is equal, and the situation of each block is different from that of the other block.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study will be conducted in a one-sided blind way, and the statistical consultants analyzing the data will be blind to the intervention
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Avicenna research institute
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
2024-11-19, 1403/08/29
Ethics committee reference number
IR.ACECR.REC.1403.012

Health conditions studied

1

Description of health condition studied
Poor ovarian response
ICD-10 code
E28
ICD-10 code description
Ovarian dysfunction

Primary outcomes

1

Description
Evaluation of reactogenicity (absence of fever, nausea, bleeding, pain and allergic reaction symptoms) of allogeneic exosome injection obtained from stem cells derived from menstrual blood
Timepoint
Within two hours, two weeks, 3 months and 6 months after exosome injection
Method of measurement
Clinical assessment

Secondary outcomes

1

Description
Spontaneous pregnancy
Timepoint
Up to 3 months after intervention
Method of measurement
Beta-HCG assay

2

Description
Number of antral follicles in the ovary
Timepoint
Before intervention, 3 months and 6 months after exosome administration
Method of measurement
Vaginal sonography

3

Description
Anti-Mullerian hormone, Estradiol, and FSH levels in blood serum
Timepoint
Before the intervention, 3 months, and 6 months after cell administration
Method of measurement
Biochemical assay

4

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

5

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

6

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

Intervention groups

1

Description
Intervention group: includes 15 patients with poor ovarian response that will be treated with two injections of allogenic exosome extracted from menstrual blood stem cells. After cell isolation, culture, and qualification in GMP grade- clean room, extracted exosome will be intravaginally injected by vaginal ultrasonography into the ovaries of patients after receiving general anesthesia.
Category
Treatment - Other

2

Description
Control group: includes 15 patients with poor ovarian response who will not receive any intervention. Their biochemical parameters, sonographic, and embryologic data will be compared with those of the intervention group.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Avicenna Fertility Clinic
Full name of responsible person
Amirhassan Zarnani
Street address
No 97, Beginning of Yakhchal Street, Shariati Ave.
City
Tehran
Province
Tehran
Postal code
1936773493
Phone
+98 21 23519
Email
zarnania@gmail.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
Amir-Hasan Zarnani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
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
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
Amir-Hasan Zarnani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
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
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
Amir-Hasan Zarnani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
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
zarnania@gmail.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
Undecided - It is not yet known if there will be 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
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