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IRCT20220510054808N1 IRCT 2022-05-15 Ghoum University of Medical Sciences Evaluation of folliculogenesis in poor responds women after intrauterine injection of autologous platelet-rich plasma Evaluation of folliculogenesis in poor responds women after intrauterine injection of autologous platelet-rich plasma 2022-05-26 anticipated 32 Complete https://irct.ir/trial/63434 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the present study, the selection of the statistical population will be made available. And patients with random block allocation will be assigned to intervention and control groups. Block size 4 will be considered. So we have six quadruple blocks consisting of AABB, ABAB, BBAA, BABA, ABBA, BAAB. The selection of each block will also be random and will be done using dice. For example, if the number 3 is rolled in a dice, the BBAA block is considered, so the first two patients are assigned to treatment B and the next two patients to treatment A. 1-2 Patients with poor ovarian response. Intervention 1: Control group: A group of poor ovarian reserve women who undergo follicular puncture without any treatment. Intervention 2: Intervention group: A group of poor ovarian reserve women undergoing ovarian PRP injection. Platelet-Rich Plasma (PRP) is administered to poor ovarian reserve women at the time of egg retrieval. PRP preparation is performed immediately after blood sample collection. Approximately 40 ml of the patient's peripheral blood is required to produce the required volume of PRP. The initial concentration of platelets in the peripheral blood is approximately 250,000 platelets per liter. The target platelet concentration in PRP was approximately 1,000,000 platelets per liter. According to our protocol, the prepared PRP can be stored at 4 ° C for one hour if needed. However, in the vast majority of participants, intrauterine injection of PRP is given immediately after preparation.Injections of both ovaries are seen through transvaginal ultrasound monitoring and are injected intra-medially at several sites using a single-lumen gauge needle 17. This technique involves penetrating the center of each ovary and then gradually injecting 3 ml of activated PRP into each ovary through a syringe connected to a transvaginal probe transducer. 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 Will be determined at the time of patient appointment
public Fatemeh Asgari
Nekuei Hedayati Forghani Educational and Medical Center ,next to Mirzai Qomi Square, Azar street, Qom
Qom Iran (Islamic Republic of) 37158 73355 +98 25 3711 8428 faasgsri@muq.ac.ir Ghoum University of Medical Sciences scientific Fatemeh Asgari
Nekuei Hedayati Forghani Educational and Medical Center ,next to Mirzai Qomi Square, Azar Street, Qom
Qom Iran (Islamic Republic of) 37158 73355 +98 25 3711 8428 faasgari@muq.ac.ir Ghoum University of Medical Sciences Iran (Islamic Republic of) previous IVF (In vitro fertilisation) that resulted in the recovery of less than three eggs or an abnormal ovarian reserve test involving less than five AFCs (Antral follicle count ) All women have a regular menstrual cycle. the level of follicles or AMH (Antimullerian Hormone) should be less than 1.1 ng / ml. those under 40 years of age. 25 years 40 years Female Autoimmune disorders, sexually transmitted diseases, infectious diseases, infertility / tubal factor tube obstruction, chronic inflammatory diseases, endometriosis, chronic endometritis, and endocrine disorders such as thyroid dysfunction. anemia, thrombophilic disorders, current cancer diagnosis, or medical history of cancer Treatment - Drugs Treatment - Drugs Control group: A group of poor ovarian reserve women who undergo follicular puncture without any treatment Intervention group: A group of poor ovarian reserve women undergoing ovarian PRP injection. Platelet-Rich Plasma (PRP) is administered to poor ovarian reserve women at the time of egg retrieval. PRP preparation is performed immediately after blood sample collection. Approximately 40 ml of the patient's peripheral blood is required to produce the required volume of PRP. The initial concentration of platelets in the peripheral blood is approximately 250,000 platelets per liter. The target platelet concentration in PRP was approximately 1,000,000 platelets per liter. According to our protocol, the prepared PRP can be stored at 4 ° C for one hour if needed. However, in the vast majority of participants, intrauterine injection of PRP is given immediately after preparation.Injections of both ovaries are seen through transvaginal ultrasound monitoring and are injected intra-medially at several sites using a single-lumen gauge needle 17. This technique involves penetrating the center of each ovary and then gradually injecting 3 ml of activated PRP into each ovary through a syringe connected to a transvaginal probe transducer. Platelet-enriched plasma cell count. Timepoint: After plasma preparation. Method of measurement: With cell counting machine. Expression of folliculogenesis genes. Timepoint: After collecting granulosa cells on the day of oocyte someone both the control group and the treated group. Method of measurement: Real time PCR. Hormone secretion levels. Timepoint: At monthly intervals after the puncture and before the puncture. Method of measurement: Immunoassay. Antral follicle count. Timepoint: At monthly intervals after the puncture and before the puncture. Method of measurement: sonography. The quality of oocytes. Timepoint: after puncture. Method of measurement: with stereomicroscope. Oocyte and embryo quality. Timepoint: after puncture. Method of measurement: With a stereomicroscope. Spontaneous fertility. Timepoint: 14 days after embryo transfer. Method of measurement: Pregnancy test and sonography. Ghoum University of Medical Sciences Approved 2022-05-10 Ethics committee of qom University of Medical Sciences Nekouei Hedayati Forghani Educational and Medical Center, Next to Mirzai Qomi Square, Azar street, Qom. qom Ghoum Iran (Islamic Republic of)