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IRCT20200905048630N5 IRCT 2023-09-22 Bandare-abbas University of Medical Sciences Investigating the effect of intraovarian administration of platelet rich plasma in patients with poor ovarian response in improving the result of assisted procedures Investigating the effect of intraovarian administration of platelet rich plasma in patients with poor ovarian response in improving the result of assisted procedures 2023-10-23 anticipated 88 Complete https://irct.ir/trial/72712 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible patients (including 88 patients) are randomly assigned by a statistical expert using simple randomization method. In this method, the Random between function of the Excel program is used to generate a random number between the number 1 and 2. This work was repeated 88 times and thus a random sequence is obtained, Blinding description: The data analyst will not know about the allocation of groups and the type of intervention performed, and the data will be provided to the analyst in the form of two groups A and B (without mentioning the names of the control group and the intervention group). 3 Reducedovarian reserve.. Intervention 1: Intervention group: 29 infertile women with reduced ovarian reserve between 18 and 45 years of age with the administration of platelet-rich plasma alone, which is prepared and injected as follows: about 8.5 cc of the patient's blood sample in two tubes containing total anticoagulant and centrifuged the sample for 10 minutes at 1600 rpm, after the end of the first round of centrifugation, transfer the upper turbid plasma to another tube and centrifuge again for 6 minutes at 3500 rpm we show At the end of the second cycle, a white deposit should be seen at the bottom of the tube. Discard the supernatant solution containing platelet-free plasma and gently stir the remaining amount and inject one and a half cc of PRP with a concentration of approximately 4-5 times that of platelets into the ovary with the help of a follicular aspiration needle under ultrasound guidance. Intervention 2: Control group: 59 infertile women with reduced ovarian reserve between 18 and 45 years without administration of platelet-rich plasma. Yes - There is a plan to make this available What will be shared: The data will be presented in the article after analysis When: 2025 To whom: Academic researchers and gynecologists and obstetricians Conditions: Clinical use in patients with reduced ovarian reserve Where to obtain: corresponding author of the article How to obtain: Email to the corresponding author Comments:
public Dr Maryam Azizi Kutenaee
Shahid Mohammadi Hospital, Parastar Street
Bandar Abbas Iran (Islamic Republic of) 7916613885 +98 76 3333 0755 maryamazizikut86@gmail.com Bandare-abbas University of Medical Sciences scientific Dr Maryam Azizi Kutenaee
Shahid Mohammadi Hospital, Parastar Street
Bandar Abbas Iran (Islamic Republic of) 7916613885 +98 76 3333 0755 maryamazizikut86@gmail.com Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Informed consent of the patient (completion of the patient consent form by the patient or the patient's companion) Patients aged 18 to 45 years. Patients who have no history of ovarian surgery or ovarian endometrioma. Normal sperm analysis • POR (age over 40 years and/or a history of poor response to high-dose stimulation with less than three oocytes and/or adverse ovarian reserve tests including AMH < 1.1 ng/nl; AFC < 7) Patients without endocrine disorders such as hyperprolactinemia, PCOS, etc. Non-smoking patients Patients who do not have cardiovascular disorders. 18 years 45 years Female Adhesion or severe damage to the pelvis or ovaries Immunological diseases Hematological diseases Platelets less than one hundred and fifty thousand per cubic millimeter Systemic use of corticosteroids within two weeks before the procedure Taking anticoagulants E28.3 Primary ovarian failure Treatment - Drugs Other Intervention group: 29 infertile women with reduced ovarian reserve between 18 and 45 years of age with the administration of platelet-rich plasma alone, which is prepared and injected as follows: about 8.5 cc of the patient's blood sample in two tubes containing total anticoagulant and centrifuged the sample for 10 minutes at 1600 rpm, after the end of the first round of centrifugation, transfer the upper turbid plasma to another tube and centrifuge again for 6 minutes at 3500 rpm we show At the end of the second cycle, a white deposit should be seen at the bottom of the tube. Discard the supernatant solution containing platelet-free plasma and gently stir the remaining amount and inject one and a half cc of PRP with a concentration of approximately 4-5 times that of platelets into the ovary with the help of a follicular aspiration needle under ultrasound guidance Control group: 59 infertile women with reduced ovarian reserve between 18 and 45 years without administration of platelet-rich plasma The number of retrieved oocytes. Timepoint: Two months after prp injection. Method of measurement: Count the number. The number of MII oocyte obtained. Timepoint: Two months after prp injection. Method of measurement: Count the number. Increase in AMH. Timepoint: The day of the prp injection, and then two months after the prp injection. Method of measurement: laboratory test. IVF cycle cancellation rate. Timepoint: Two months after PRP injection. Method of measurement: Count the number. Clinical pregnancy rate. Timepoint: 6 weeks after embryo transfer. Method of measurement: Vaginal ultrasound. Live birth rate. Timepoint: 9 months after embryo transfer. Method of measurement: Count the number. Ongoing pregnancy rate. Timepoint: 20 weeks after embryo transfer. Method of measurement: Ultrasound. Bandare-abbas University of Medical Sciences Approved 2023-09-17 Ethic committee of Hormozgan University of medical sciences Deputy of research and technology, campus of Hormozgan University of Medical Sciences, Imam Hossein boulevard, Bandar Abas, Iran Bandar Abbas Hormozgan Iran (Islamic Republic of)