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Study of the Effect of injecting the combination of exosomes extracted from follicular flouid,PRP & gonadotropns into the ovaries of POF & POI 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: IRCT20230528058312N1
Registration date: 2023-06-07, 1402/03/17
Registration timing: prospective

Last update: 2023-06-07, 1402/03/17
Update count: 0
Registration date
2023-06-07, 1402/03/17
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
2023-06-22, 1402/04/01
Expected recruitment end date
2024-05-21, 1403/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the Effect of injecting the combination of exosomes extracted from follicular flouid,PRP & gonadotropns into the ovaries of POF & POI Patients.
Public title
Study of the Effect of the combination of exosomes extracted from follicular flouid,PRP & gonadotropns into the ovaries of POF & POI Patients.
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
2
Groups that have been masked
No information
Sample size
Target sample size: 24
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
Shahzad Seyed Ali St., Islamic Azad University, Qom branch
City
Qom
Province
Ghoum
Postal code
3747113135
Approval date
2023-04-11, 1402/01/22
Ethics committee reference number
IR.IAU.QOM.REC.1402.077

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

empty

Intervention groups

1

Description
1.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
2.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
3.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
4.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
5.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
7.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
Control 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). they do not receive any stimulants.
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,Specialized Infertility treatment And limited surgery Center
Full name of responsible person
seyed Reza Tabatabaee Qomi
Street address
Superspecialized Infertility Treatment And surgurycenter,Tahoora street,Jamkaran,
City
Qom
Province
Ghoum
Postal code
3747113135
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,Specialized Infertility treatment And limited surgery Center
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
Dr.seyed Reza Tabatabaee Qomi
Position
Treatmen Manager
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tahoora infertility treatment and lmited surgury clinic
Full name of responsible person
Dr.seyed Reza Tabatabaee Qomi
Position
Treatmen Manager
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
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

Person responsible for updating data

Contact
Name of organization / entity
Tahoora infertility treatment and lmited surgury clinic
Full name of responsible person
Dr.seyed Reza Tabatabaee Qomi
Position
Treatmen Manager
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Tahoora infertility treatment and lmited surgury clinic,Jamkaran,Tahoora street
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 is shareable after de-identifying Participants
When the data will become available and for how long
Since March 2024
To whom data/document is available
Researchers and Treatment Centers
Under which criteria data/document could be used
method and statistical analysis of the request can be used via email
From where data/document is obtainable
Through The Corresponded Email:taba_1359@yahoo.com
What processes are involved for a request to access data/document
En after about a week of requesting by email, if the request can be acceptable it will be sent
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