]>
IRCT20230528058312N1 IRCT 2023-06-07 Tahoora,Specialized Infertility treatment And limited surgery Center Study of the Effect of the combination of exosomes extracted from follicular flouid,PRP & gonadotropns into the ovaries of POF & POI Patients. Study of the Effect of injecting the combination of exosomes extracted from follicular flouid,PRP & gonadotropns into the ovaries of POF & POI Patients. 2023-06-22 anticipated 24 Complete https://irct.ir/trial/70439 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2 Premature Ovarian failure(POF) / Premature Ovarian Insufficiency (POI). Intervention 1: 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. Intervention 2: 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. Intervention 3: 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. Intervention 4: 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. Intervention 5: 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. Intervention 6: 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. Intervention 7: 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. Intervention 8: 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. Yes - There is a plan to make this available What will be shared: All data is shareable after de-identifying Participants When: Since March 2024 To whom: Researchers and Treatment Centers Conditions: method and statistical analysis of the request can be used via email Where to obtain: Through The Corresponded Email:taba_1359@yahoo.com How to obtain: En after about a week of requesting by email, if the request can be acceptable it will be sent Comments:
public Dr.seyed Reza Tabatabaee Qomi
Tahoora infertility treatment and lmited surgury clinic,Tahoora street,Jamkaran
Qom Iran (Islamic Republic of) 3747113135 +98 25 3725 4719 taba_1359@yahoo.com Tahoora infertility treatment and lmited surgury clinic scientific Dr.seyed Reza Tabatabaee Qomi
Tahoora infertility treatment and lmited surgury clinic,Tahoora Street, Jamkaran
Qom Iran (Islamic Republic of) 3747113135 +98 25 3725 4719 taba_1359@yahoo.com Tahoora infertility treatment and lmited surgury clinic Iran (Islamic Republic of) Women with premature menopause POF Women with premature ovarian failure POI Normal women with Grade A eggs 20 years 40 years Female Women with idiopathic infertility Women with adequate ovarian reserve N97.0 Female infertility associated with anovulation Treatment - Other Treatment - Other Treatment - Other Treatment - Other Treatment - Other Treatment - Other Treatment - Other Treatment - Other 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. 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. 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. 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. 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. 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. 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. 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. 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. Tahoora,Specialized Infertility treatment And limited surgery Center Approved 2023-04-11 Islamic Azad University, Qom branch Shahzad Seyed Ali St., Islamic Azad University, Qom branch Qom Ghoum Iran (Islamic Republic of)