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IRCT20160722029027N12 IRCT 2022-05-14 Shahid Beheshti University of Medical Sciences Comparison of the effect of intraovarian injection of PRGF and PRP on improving the response and pregnancy outcomes Comparison of the effect of intraovarian injection of Plasma Rich Growth Factor (PRGF) and Plasma Rich Platelate (PRP) on improving the response and pregnancy outcomes in women undergoing IVF with poor ovarian response 2022-05-10 anticipated 30 Complete https://irct.ir/trial/59367 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done by generating random numbers in Excel software. 1. In a column of Excel we enter 25 samples in each group. 2. In the next column we generate random numbers using the following command: RAND 3. After sorting the generated random numbers, a random list will be generated according to which people will be assigned to two groups, Blinding description: Blindness will be such that the patient will not know what treatment she will receive. Also, the researcher who records the results will not be aware of the type of treatment applied to the patient. 2 patient with diminished ovarian reserve. Intervention 1: In the intervention group, 1:35 cc of blood is taken from women. The blood sample is centrifuged at 1200 rpm for 12 minutes to separate the red blood cells. The extracted plasma is centrifuged at 3500 rpm for 7 minutes. Three cc of plasma remains in each tube, which is injected into the ovary through the vagina within 20 minutes after preparation for injection with a special ovulation needle. Intervention 2: In intervention group 2: first,1.5 cc of platelet activating factor made by the company (Aria based on diagnosis) will be added to 3 cc of platelet-rich plasma and after 20 minutes, two phases will be created in plasma preparation. A portion of platelet debris will be formed at the top and a portion of growth factor-rich plasma at the bottom. In the last step, it will be centrifuged for 4 minutes at 4000 rpm. The supernatant is then drawn with a needle and the sample will be taken with an ovulation needle through the ovary. Yes - There is a plan to make this available What will be shared: Only information about the main outcome, including chemical pregnancy, clinical pregnancy, ongoing pregnancy, abortion rate, and possible complications from the intervention, can be shared. When: Without restriction To whom: All researchers Conditions: With permission from the responsible authorEmail to the responsible author Where to obtain: Email to the responsible author How to obtain: Email to the responsible author Comments:
public Zahra Razghandi
Velenjak,Yaman St, Chamran highway
Tehran Iran (Islamic Republic of) 1983969411 +98 21 2243 2560 z.razghandi@gmail.com Shahid Beheshti University of Medical Sciences scientific Leila Nazari
Velenjak, Yaman St, Chamran highway
Tehran Iran (Islamic Republic of) 1983969411 021230311 leynaz@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Women under the age of 42 Having a history of low ovarian reserve (less than 3 eggs in the previous IVF cycle) Abnormal laboratory tests anti mulerian hormone fewer than 1.1ng /dl Counting antral follicles 5-7 on transvaginal sonography no limit 42 years Female Women with anemia diagnosis history of malignancy Any endocrine disorders (hypothyroidism, hyperprolactinemia) Treatment - Surgery Treatment - Surgery In the intervention group, 1:35 cc of blood is taken from women. The blood sample is centrifuged at 1200 rpm for 12 minutes to separate the red blood cells. The extracted plasma is centrifuged at 3500 rpm for 7 minutes. Three cc of plasma remains in each tube, which is injected into the ovary through the vagina within 20 minutes after preparation for injection with a special ovulation needle. In intervention group 2: first,1.5 cc of platelet activating factor made by the company (Aria based on diagnosis) will be added to 3 cc of platelet-rich plasma and after 20 minutes, two phases will be created in plasma preparation. A portion of platelet debris will be formed at the top and a portion of growth factor-rich plasma at the bottom. In the last step, it will be centrifuged for 4 minutes at 4000 rpm. The supernatant is then drawn with a needle and the sample will be taken with an ovulation needle through the ovary The rate of clinical pregnancy in the two groups undergoing PRGF and the PRP. Timepoint: 4 week after embryo transfer. Method of measurement: By seeing the fetal heartbeat on ultrasound. The number of retrieved oocytes in the two groups injected with PRGF and PRP. Timepoint: During ovarian puncture. Method of measurement: counting. Shahid Beheshti University of Medical Sciences Approved 2022-03-06 Ethics committee of Shahid Beheshti University of Medical Sciences Velenjak, Yaman St, Chamran highway Tehran Tehran Iran (Islamic Republic of)