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Investigating the effect of injecting the combination of exosomes extracted from follicular fluid, stem cells extracted from Wharton's jelly, platelets enriched from blood plasma and gonadotropins into the ovaries of poi, pof patients.

Protocol summary

Study aim
Stimulation of follicular growth in patients and recovery of menstrual cycle and sex hormone levels followed by the birth of a live child Investigating the effect of exosomes with gonadotropins and PRP
Design
20 qualified patients refers to Tahoora cilinic(QOM) will be selected.Medical history, general, abdominal and local examinations, clinical tests (general status using CBC, liver, kidney, thyroid and ovarian function tests by FSH, LH, E2, AMH, ultrasound and chromosomal examination to confirm karyotype) Healthy typing will be checked. Exosomes is extracted from follicular fluid by PEG method, then they will be injected together with enriched plasma (PRP) into the ovarian tissue of POF and POI patients.
Settings and conduct
This study will be conducted in Tahura Infertility Center, for this purpose 10 qualified clients of Tahura Infertility Center will be selected. All cases in terms of medical history, general, abdominal and local examinations, clinical tests (general condition using CBC, test, kidney, thyroid and ovarian function by FSH, LH, E2, AMH, ultrasound and chromosomal examination to confirm karyo) . Healthy typing will be checked
Participants/Inclusion and exclusion criteria
Women with premature menopause POF Women with premature ovarian failure POI Normal women with Grade( A) eggs Non-entry conditions: Idiopathic infertile women
Intervention groups
This study was conducted on eight groups: 1.The first group will not receive any stimulus as a control. 2.Only exosome. 3.Only PRP. 4.only gonadotropin. 5. Exosome and PRP. 6. Exosome and gonadotropin. 7.Gonadotropin and PRP 8. Exosome, gonadotropin and PRP, they will receive.
Main outcome variables
increase ovarian reserve; proper ovarian function; The possibility of fertility of POF, POI women; recovery of menstrual cycle and sex hormone levels; Birth of a live child

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230528058312N3
Registration date: 2024-02-19, 1402/11/30
Registration timing: prospective

Last update: 2024-02-19, 1402/11/30
Update count: 0
Registration date
2024-02-19, 1402/11/30
Registrant information
Name
Seyed Reza Tabatabaee Qomi
Name of organization / entity
Tahoora Infertility Treatment & limited surgery Clinic
Country
Iran (Islamic Republic of)
Phone
+98 25 3725 4719
Email address
tahoora.clnic@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of injecting the combination of exosomes extracted from follicular fluid, stem cells extracted from Wharton's jelly, platelets enriched from blood plasma and gonadotropins into the ovaries of poi, pof patients.
Public title
Exosome and stem cells therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with premature menopause POF Women with premature ovarian failure POI Normal women with Grade A eggs
Exclusion criteria:
Women with idiopathic infertility Women with adequate ovarian reserve
Age
From 20 years old to 40 years old
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
N/A
Randomization description
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
Islamic Azad University, Qom branch
Street address
15 Khordad St., Islamic Azad University, next to Social Security Insurance, Qom branch, Iran
City
Ghoum
Province
Ghoum
Postal code
3747113135
Approval date
2024-02-19, 1402/11/30
Ethics committee reference number
IR.IAU.QOM.REC.1402.206

Health conditions studied

1

Description of health condition studied
Premature Ovarian failure(POF) / Premature Ovarian Insufficiency (POI)
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation

Primary outcomes

1

Description
Absence of eggs in the ovaries of women under 40 years and primary or secondary amenorrhea for more than 4 months in women under 40 years with an elevated serum level of Follicular Stimulated Hormone(higher than 25 mIU/mL
Timepoint
15 days after the injection and then every month at the time of ovulation during one year
Method of measurement
Transvaginal ultrasound device, Hormonal Test by Elisa Kit.

Secondary outcomes

1

Description
Absence of eggs in the ovaries of women under 40 years and primary or secondary amenorrhea for more than 4 months in women under 40 years with an elevated serum level of Follicular Stimulated Hormone(higher than 25 mIU/m
Timepoint
15 days after the injection and then every month at the time of ovulation during one year
Method of measurement
Transvaginal ultrasound device, Hormonal Test by Elisa Kit.

Intervention groups

1

Description
Intervention group: Infertile women with primary or secondary amenorrhea for more than 4 months under 40 years old with an elevated serum level of FSH (higher than 25 mIU/mL).This group only autologous PRP(plate rich plasma) will be received. PRP was prepared from 40 mL of peripheral blood by the buffy coat protocol In brief, whole blood was divided into two aliquots and centrifugedat 3,000 rpm for 8 min at room temperature to form three layers.The top platelet poor plasma and the middle layerwere transferred to another two sterile tube and then centrifugedagain at 4,000 rpm for 5 min. After removal of upper portion of the supernatant, each pellet was reconstituted with 2.5 ml of supernatant. patient is lying in the dorsal lithotomy position, and a needle (Towako Trans myometrial Set 18 GA× 325 mm, Cook, Australia)with an angle of 15 to 30 degrees is advanced into ovarian stroma under vaginal ultrasound guidance (Honda 2000). Under intravenous sedation using 100 mg propofol (Fresenius Kabi Austria GmbH, Graz,Austria). No antibiotic will not be used, and the patient withstood the process without painful sensation.
Category
Treatment - Other

2

Description
Intervention group: Infertile women with primary or secondary amenorrhea for more than 4 months under 40 years old with an elevated serum level of FSH (higher than 25 mIU/mL).this group receive exosome (100μg/ml)from the follicular fluid of fertile women referred to Tahura infertility center for IVF due to male factor infertility , who have been examined for HIV, HCV and HPV health and have grade A eggs, will be extracted according to the protocol provided by Eswaran with the help of Andreu Polyethylene glycol (PEG) (600 kDa). In order to check the presence of exosomes with the Mrestro brand nanodrop spectrophotometer, the concentration of DNA and RNA, with the ZEISS brand SEM electron microscope, the presence of exosomes will be checked. In addition, CD9, CD 63, CD81, CD82 factors will be checked with the help of Beckman brand flow cytometry.on the second and fifth day of the participants' menstrual cycle will be injected into their superficial layer of the ovary, only once during the treatment cycle.The patient is lying in the dorsal lithotomy position, and a needle (Towako Trans myometrial Set 18 GA× 325 mm, Cook, Australia)with an angle of 15 to 30 degrees is advanced into ovarian stroma under vaginal ultrasound guidance (Honda 2000). Under intravenous sedation using 100 mg propofol (Fresenius Kabi Austria GmbH, Graz,Austria). No antibiotic will be used, and the patient withstood the process without painful sensation.
Category
Treatment - Other

3

Description
Intervention group: Infertile women with primary or secondary amenorrhea for more than 4 months under 40 years old with an elevated serum level of FSH (higher than 25 mIU/mL)only gonadotropin ,1 ml of 150 IU of FSH/75 IU of LH (Pergoveris,MerckSerono, Aubonne, Switzerland) was slowly infused into ovarian tissue, 0.5 ml in each ovary, under intravenous sedationusing 100 mg propofol (Fresenius Kabi Austria GmbH, Graz,Austria). No antibiotic is used, and the patient withstood the process without painful sensation. No visible side effect will be noted in the whole procedure.
Category
Treatment - Other

4

Description
Intervention group: nfertile women with primary or secondary amenorrhea for more than 4 months under 40 years old with an elevated serum level of FSH (higher than 25 mIU/mL).this group receive exosome (100μg/ml)and autologous PRP(4ml) , under intravenous sedationusing 100 mg propofol (Fresenius Kabi Austria GmbH, Graz,Austria). No antibiotic will be used, and the patient withstood the process without painful sensation.
Category
Treatment - Other

5

Description
Intervention group: Infertile women with primary or secondary amenorrhea for more than 4 months under 40 years old with an elevated serum level of FSH (higher than 25 mIU/mL)will be received gonadotropin 1(150IUrFSH/75 IU rLH, Pergoveris,MerckSerono, Aubonne, Switzerland) and exosome (100μg/ml)extracted from Follicular fluid of fertile woman injected under intravenous sedation using 100 mg propofol (Fresenius Kabi Austria GmbH, Graz,Austria). No antibiotic is used, and the patient withstood theprocess without painful sensation. No visible side effect is notedin the whole procedure.
Category
Treatment - Other

6

Description
Intervention group: Infertile women with primary or secondary amenorrhea for more than 4 months under 40 years old with an elevated serum level of FSH (higher than 25 mIU/mL) receive gonadotropin 1ml(150IUrFSH/75IU rLH) (Pergoveris,MerckSerono, Aubonne, Switzerland) andautologous PRP (4mL) prepared by by the buffy coat protocol be injected under intravenous sedation using 100 mg propofol (Fresenius Kabi Austria GmbH, Graz,Austria). No antibiotic is used, and the patient withstood theprocess without painful sensation.
Category
Treatment - Other

7

Description
Intervention group: infertile women with primary or secondary amenorrhea for more than 4 months under 40 years old with an elevated serum level of FSH (higher than 25 mIU/mL)received gonadotropin 1ml(150IUrFSH/75IU rLH) (Pergoveris,MerckSerono, Aubonne, Switzerland) ,autologous PRP (4mL) prepared by by the buffy coat Porotocole and exosome (100μg/ml)extracted from Follicular fluid of fertile woman injected under intravenous sedation using 100 mg propofol (Fresenius Kabi Austria GmbH, Graz,Austria). No antibiotic is used, and the patient withstood theprocess without painful sensation.
Category
Treatment - Other

8

Description
Intervention group:Infertile women under the age of 40 for at least 4 months with primary or secondary amenorrhea with an increase in FSH serum level (above 25 mIU/mL) for this group, UC-MSC stem cells from human umbilical cord tissue, obtained from normal healthy deliveries, were donated for this group. They have come to be separated. Finally, Wharton jelly mesenchymal stem cells will be obtained through enzymatic digestion of umbilical cord cells using 1.67% collagenase (Sigma, C9891, Saint Louis, MO, USA) at 37°C.After dissociation, cells were lysed up to passage 5 using α-MEM (Gibco, 32561-102, Carlsbad, CA, USA) supplemented with 4 mM Glutamax (Gibco, 35050-079, Carlsbad, CA, USA) and bovine serum. Inactivated 10% will multiply. (Gibco, 16000044, Grand Island, NY, USA). Finally, vials containing pure UC-MSC mesenchymal stem cells using 6% hydroxyethyl starch (Claris, G/LVP-5, Ellisbridge, Ahmedabad, India) with 10% dimethyl sulfoxide (Sigma, D2650, Irvine, England). which will be frozen and quarantined by the vitrification method.Finally, randomly vials (before freezing and after thawing), in terms of life; Proliferation, mycoplasma, endotoxin, growth and differentiation will be reviewed. Before each treatment, cell vials will be selected according to the total number of viable cells obtained by quality controls (using flow cytometry and the Cell Counter device) after freezing and thawing (following the syringe preparation steps) to determine the required cell dose. need the protocol. Finally, to reach the therapeutic goal of 9 million stem cells in each infusion, vials containing stem cells will be adjusted. In addition, factors CD9, CD 63, CD81, CD82 will be evaluated with the help of Beckman Coulter brand flow cytometry. Finally, the stem cells extracted with the required concentration on day 2 and 5 will be added to the surface layer of the ovary if the patient is in dorsal lithotomy mode. Lying down with the help of a puncture needle (Towako (Transmyometrial Set 18 GA x 325 mm, Cook) with an angle of 15 to 30 degrees towards the ovary and with the guidance of the 2000 Honda vaginal ultrasound machine, it will be done only once during the treatment cycle.Before the injection, the patient will be put into artificial sleep with the help of an intravenous sedative using 100 mg of propofol (Fresenius Kabi Austria GmbH, Graz, Austria). No antibiotics will be used. According to previous studies, this process is painless and has no visible side effects.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Tahoora,Specialized Infertility Treatment And limited Surgery Center
Full name of responsible person
Dr. seyed Reza Tabatabaee Qomi
Street address
Tahoora infertility treatment and lmited surgury clinic,Tahoora steet, Jamkarant
City
Qom
Province
Ghoum
Postal code
3747113135
Phone
+98 912 746 0016
Email
taba_1359@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tahoora infertility treatment and lmited surgury clinic
Full name of responsible person
Seyed Reza Tabatabaee Qomi
Street address
Superspecialized Infertility Treatment And surgurycenter,Tahoora street,Jamkaran,
City
Ghoum
Province
Ghoum
Postal code
Ghoum
Phone
+98 912 746 0016
Email
taba_1359@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tahoora infertility treatment and lmited surgury clinic
Proportion provided by this source
90
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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Tahoora infertility treatment and lmited surgury clinic
Full name of responsible person
Seyed Reza Tabatabaee Qomi
Position
Treatment Manager
Latest degree
Ph.D.
Other areas of specialty/work
Infertility
Street address
Tahoora infertility treatment and lmited surgury clinic,Tahoora street,Jamkaran
City
ghoum
Province
Ghoum
Postal code
3747113135
Phone
+98 25 3725 4719
Email
taba_1359@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tahoora infertility treatment and lmited surgury clinic
Full name of responsible person
Seyed Reza Tabatabaee Qomi
Position
Treatmen Manager
Latest degree
Ph.D.
Other areas of specialty/work
Infertility
Street address
Tahoora infertility treatment and lmited surgury clinic,Tahoora street,Jamkaran
City
Ghoum
Province
Ghoum
Postal code
3747113135
Phone
+98 25 3725 4719
Email
taba_1359@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tahoora infertility treatment and lmited surgury clinic
Full name of responsible person
Tahoora infertility treatment and lmited surgury clinic
Position
Treatment Manager
Latest degree
Ph.D.
Other areas of specialty/work
Infertility treatment and lmited surgury clinic
Street address
Tahoora infertility treatment and lmited surgury clinic,Tahoora street,Jamkaran
City
Qom
Province
Ghoum
Postal code
3747113135
Phone
+98 25 3725 4719
Email
taba_1359@yahoo.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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data obtained after identification of study cases can be shared.
When the data will become available and for how long
All information is accessible in April 2025.
To whom data/document is available
Our data will be available for all researchers and Doctors
Under which criteria data/document could be used
All information related to the performed ultrasounds, tests related to exosome and stem cell extraction will be accessible
From where data/document is obtainable
Applicants can contact one of the following email addresses to receive documents or data: asalighe@yahoo.com taba_1359@yahoo.com
What processes are involved for a request to access data/document
Three weeks after sending the applicant's message, the requested documents and files will be sent.
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