Protocol summary

Study aim
Investigating the effectiveness of autologous Platelet-Rich Plasma (PRP) and Condition Medium of mesenchymal stem cells derived from the umbilical cord on the serum level of Anti Mullerian Hormone (AMH)
Design
Clinical trial with a control group, with parallel groups, no blinding, randomized, phase1,2 on 44 patients.
Settings and conduct
1. Patient identification 2. Preparation of umbilical cord from a newborn in Imam Khomeini Hospital, Sari 3. Preparation of Condition Medium of mesenchymal stem cells derived from the umbilical cord in the clean room of Sina Mehr Fajr Laboratory, Sari 4. Preparation of PRP in Imam Khomeini Hospital, Sari 5. Injection into the ovaries in the operating room of Imam Khomeini Hospital, Sari 6. Examination of serum AMH and AFC levels of patients before injection and 2, 6 and 14 weeks after injection
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women between 20 and 45 years of age, infertility for more than one year, having poor or diminished ovarian reserve, and one of the poor ovarian response criteria, which are: Total AFC in both ovaries 7 or less on vaginal ultrasound, AMH less than 1.1 ng/ml, history of IVF with 3 or less eggs, signing informed consent form. Exclusion criteria: Pregnancy, history of IgA deficiency or currently, surgery leading to pelvic adhesions, taking anticoagulant drugs, mental illness with drug dependence, chronic malignancies or chronic pelvic pain, severe male factor infertility, drug addiction, endometriosis and abnormal uterine shape observed on hysterosalpingography, failure to sign the informed consent form.
Intervention groups
4 intervention groups: One group is injected with only autologous PRP, the other group with only Condition Medium, the next group with Condition Medium and PRP concurrently, and no injection for the control group.
Main outcome variables
Anti Mullerian Hormone, Antral Follicle Count

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231230060569N2
Registration date: 2024-12-30, 1403/10/10
Registration timing: prospective

Last update: 2024-12-30, 1403/10/10
Update count: 0
Registration date
2024-12-30, 1403/10/10
Registrant information
Name
Manizheh Habibpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3334 2905
Email address
manizheh.habibpour@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-20, 1403/11/01
Expected recruitment end date
2025-07-23, 1404/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of autologous Platelet-Rich Plasma and Condition Medium of mesenchymal stem cells derived from the umbilical cord on the serum level of Anti Mullerian Hormone in infertile women with Diminished Ovarian Reserve
Public title
Cell therapy in infertile women with Diminished Ovarian Reserve
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women between 20 and 45 years old Having poor or diminished ovarian reserve and having one of the criteria for poor ovarian response, which are: total number of Antral Follicles Count in both ovaries 7 or less on vaginal ultrasound, AMH less than 1.1 ng/ml, history of IVF with 3 or fewer eggs Reading and signing the informed consent form
Exclusion criteria:
Pregnancy History or current IgA deficiency History of surgery leading to pelvic adhesions Taking anticoagulant medications Mental illness with dependence on drug use Chronic malignancies or chronic pelvic pain Infertility due to severe male factor Drug addiction Endometriosis and abnormal uterine shape observed in hysterosalpingogram Failure to sign the informed consent form
Age
From 20 years old to 45 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
To allocate samples to each group, the random block method will be used. For this purpose, patients will receive numbers 1 to 44 according to their arrival. The randomization unit will be individual and by number with blocks of 4 people. The selection of the type of group for each individual will be done through the statistical software 2 allocation random. To create a random sequence, the software will generate codes A, B, C, D, and each code will be considered for one group. Finally, the codes will be placed in a sealed envelope and the number of each patient will be written on the envelope. In the order of each patient's arrival, the doctor will open the envelope and apply the desired treatment.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The output of this project is the acquisition of technical knowledge to create a new cell therapy protocol for DOR patients, and finally, after the evaluation of clinical trials, it can enter the health market as a knowledge-based and technological product or service.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Somayeh Intersection (Tahmaseb Abad), Beginning of Jihad Boulevard, Beginning of Ibn Sina Street
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2024-11-25, 1403/09/05
Ethics committee reference number
IR.KMU.REC.1403.396

Health conditions studied

1

Description of health condition studied
Diminished Ovarian Reserve(DOR)
ICD-10 code
E28.9
ICD-10 code description
Ovarian dysfunction, unspecified

Primary outcomes

1

Description
Anti Mullerian Hormone
Timepoint
before injection and 2, 6 and 14 weeks after injection
Method of measurement
ELISA KIT

2

Description
Antral Follicle Count(AFC)
Timepoint
before injection and 2, 6 and 14 weeks after injection
Method of measurement
Vaginal ultrasound

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Injection of 1 ml of autologous PRP in 1 step into the ovaries of DOR patients under mild anesthesia with ultrasound guidance
Category
Treatment - Other

2

Description
Intervention group: Injection of 1 ml Condition Medium of mesenchymal stem cells derived from umbilical cord in 1 step into the ovaries of DOR patients under mild anesthesia with ultrasound guidance
Category
Treatment - Other

3

Description
Intervention group: Simultaneous injection of 1 ml of autologous PRP and Condition Medium of mesenchymal stem cells derived from umbilical cord in 1 stage into the ovaries of DOR patients under mild anesthesia with ultrasound guidance
Category
Treatment - Other

4

Description
Control group: No injection
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Marzieh Zamaniyan
Street address
Razi Ave.
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700 ext. 4
Fax
+98 11 3336 3754
Email
marziehzamaniyan@gmail.com
Web page address
https://imamhospital.mazums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hamid Sharifi
Street address
Somayeh Crossroads (Tahmaseb Abad), beginning of Ibn Sina Street, Deputy for Research and Technology
City
Kerman
Province
Kerman
Postal code
7613753767
Phone
+98 34 3226 3855
Fax
+98 34 3226 3857
Email
sharifihami@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
1
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
Mazandaran University of Medical Sciences
Full name of responsible person
Manizheh Habibpour
Position
Student
Latest degree
Master
Other areas of specialty/work
Hematology
Street address
N0.94, Dolat Ave., Pasdaran Blvd., Sari Town
City
Sari
Province
Mazandaran
Postal code
4814979583
Phone
+98 11 3334 2905
Email
manizheh.habibpour@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Alireza Farsinejad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Beginning of Haft Bagh Alavi axis, University of Medical Sciences campus, Faculty of Paramedical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5374
Email
farsinezhad239@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Manizheh Habibpour
Position
Student
Latest degree
Master
Other areas of specialty/work
Hematology
Street address
No. 94, Dolat Ave., Pasdaran Blvd., Sari Town
City
Sari
Province
Mazandaran
Postal code
4814979583
Phone
+98 11 3334 2905
Email
manizheh.habibpour@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
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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