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IRCT20210228050535N1 IRCT 2022-02-27 Mazandaran University of Medical Sciences Exosome therapy in infertility Evaluation of effect of the autologous exosomes derived from menstrual blood mesenchymal cells on the ovarian reserve follicles and the rate of pregnancy in patients with Diminished Ovarian Reserve (DOR) 2022-02-04 anticipated 30 Complete https://irct.ir/trial/59982 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A random series of 30 individuals were produced for eligible patients. In each sequence, the intervention group with autologous exosome and the control group would be considered by a 1:1 ratio; thus, 15 patients will be allocated to each group. Random Sequence will be provided using Sealed Envelope web site with block size of 4. 1-2 Diminished ovarian reserve. Intervention 1: Intervention group: 5 mililiter of menstrual blood sample will be collected from patients with menstrual cup. Mesenchymal cells will be isolated and cultured from a menstrual blood sample. After culturing menstrual blood-derived mesenchymal cells, in the fifth passages, the cells will be identified by Flow cytometry.Then exosomes will be isolated from the culture medium by Chromatography. Intra-ovarian injection of autologous exosomes will be performed in the intervention group. On the day of injection (follicular phase of menstrual cycle until day 14) 2 mililiter (ml) of autologous exosome with 1 percent phosphate buffered saline(PBS) with a total protein of 20 micrograms per microliter will be injected into the ovary with a puncture needle from the cortex to the medulla in several areas under ultrasound guide. Intervention 2: Control group: For patients in the control group, the in vitro fertilization (IVF) cycle with antagonist will be performed, then after 1 to 3 months, the freeze embryo will be transferred. From day 1 to 3 cycles, vaginal ultrasound will be performed. FSH recombinant ampoule (2-4 pieces) will be prescribed. Then ultrasound is performed every other day and depending on the number and size of the follicle, Human Menopausal Gonadotropins (HMG) will be added or subtracted to the drugs.If a follicle above 12 millimeter (mm) is observed, the antagonist is started and will be prescribed daily. Whenever 17-18 millimeter (mm) follicle is observed, Human Chorionic Gonadotropin (HCG) is injected and an ovarian puncture will be performed 34-48 hours later, and the ovums will be delivered to a laboratory for in vitro fertilization. 1 to 3 months later, 1 to 3 grade A or B embryos will be transferred to the patient during the hormonal cycle. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Shabanali Khodashenas Limoni
Mazandaran University of Medical Sciences,17 km of Farahabad Road, Farahabad Square
Sari Iran (Islamic Republic of) ۴۸۱۵۷۳۳۹۷۱ +98 11 3311 8945 s.khodashenas@mazums.ac.ir Mazandaran University of Medical Sciences scientific Shabanali Khodashenas limoni
Department of Medical Biotechnology, Faculty of Advanced Medical Sciences, Payambar Azam Camplex, Farah Abad Bulvd
Sari Iran (Islamic Republic of) ۴۸۱۵۷۳۳۹۷۱ +98 11 3354 3353 s.khodashenas@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients aged 20-42 Years Body mass index (BMI) below 30 (kilograms per square meters) Diagnosed diminished ovarian reserve (DOR) Antral follicles below 7 Anti Mullerian Hormone (AMH) below 1.1 nanogram per mililiter (ng/ml) Premature ovarian insufficiency (POI) Unovulation or amnehorreha 20 years 42 years Female Abnormal shape of the uterus on Hysterosalpingography (HSG) or hysteroscopy Hematologic or immunologic diseases Hormonal disturbances Chromosomal and genetics abnormalities Pregnant patients Obstruction of fallopian tubes on Hysterosalpingography or laparoscopy Patients affected by Thyroid disease Patients affected by diabetes Chronic malignancies Chronic pelvic pain Infertility due to severe male factor N97.0 Female infertility associated with anovulation Treatment - Other Treatment - Other Intervention group: 5 mililiter of menstrual blood sample will be collected from patients with menstrual cup. Mesenchymal cells will be isolated and cultured from a menstrual blood sample. After culturing menstrual blood-derived mesenchymal cells, in the fifth passages, the cells will be identified by Flow cytometry.Then exosomes will be isolated from the culture medium by Chromatography. Intra-ovarian injection of autologous exosomes will be performed in the intervention group. On the day of injection (follicular phase of menstrual cycle until day 14) 2 mililiter (ml) of autologous exosome with 1 percent phosphate buffered saline(PBS) with a total protein of 20 micrograms per microliter will be injected into the ovary with a puncture needle from the cortex to the medulla in several areas under ultrasound guide. Control group: For patients in the control group, the in vitro fertilization (IVF) cycle with antagonist will be performed, then after 1 to 3 months, the freeze embryo will be transferred. From day 1 to 3 cycles, vaginal ultrasound will be performed. FSH recombinant ampoule (2-4 pieces) will be prescribed. Then ultrasound is performed every other day and depending on the number and size of the follicle, Human Menopausal Gonadotropins (HMG) will be added or subtracted to the drugs.If a follicle above 12 millimeter (mm) is observed, the antagonist is started and will be prescribed daily. Whenever 17-18 millimeter (mm) follicle is observed, Human Chorionic Gonadotropin (HCG) is injected and an ovarian puncture will be performed 34-48 hours later, and the ovums will be delivered to a laboratory for in vitro fertilization. 1 to 3 months later, 1 to 3 grade A or B embryos will be transferred to the patient during the hormonal cycle. Estradiol rate of change. Timepoint: 2 weeks before injection and 1 to 3 months after injection. Method of measurement: ELISA diagnostic kit. The ovarian follicle growth rate of change. Timepoint: 2 weeks before injection and 1 to 3 months after injection. Method of measurement: Ultrasound. Oocyte quality rate of change. Timepoint: 2 weeks before injection and 1 to 3 months after injection. Method of measurement: Oocyte classification based on presence or absence of polar body and nucleolus. Follicle Stimulating Hormone (FSH) rate of change. Timepoint: 2 weeks before injection and 1 to 3 months after injection. Method of measurement: ELISA diagnostic kit. Anti Mullerian Hormone (AMH) rate of change. Timepoint: 2 weeks before injection and 1 to 3 months after injection. Method of measurement: ELISA diagnostic kit. Pregnancy rate. Timepoint: 1 to 3 months after injection and 12 weeks after pregnancy. Method of measurement: Beta-Human Chorionic Gonadotropin(B HCG) test, Ultrasound. Live newborn birth rate. Timepoint: 9 to 12 months after injection. Method of measurement: Follow up. Abortion rate. Timepoint: 1 to 9 month after pregnancy. Method of measurement: Ultrasound, follow up. Mazandaran University of Medical Sciences Approved 2021-10-13 Research Ethics Committees of Imam Hospital-Mazandaran University of Medical Sciences Imam Hospital, Amir Mazandarani St, Imam Sq, Sari Sari Mazandaran Iran (Islamic Republic of)