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IRCT20180818040828N2 IRCT 2018-11-22 Yazd University of Medical Sciences The effect of Autologous Platelet-Rich Plasma (PRP) on ovarian function The effect of Autologous Platelet-Rich Plasma (PRP) on ovarian function in patients with premature ovarian failure and poor ovarian reserve 2018-09-01 anticipated 30 Complete https://irct.ir/trial/35218 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Other design features: This study consider two different groups (POF and poor ovarian reserve) and we do one similar procedure (injection of PRP in ovary) for them and study two group separately. 2 Condition 1: Premature ovarian failure. Condition 2: Poor ovarian responders. Intervention 1: First intervention group(premature ovarian failure): At first test serum AMH, estradiol (E2), FSH and LH a few days before intervention. In intervention day PRP process with Rooyagen kit. Approximately, 8.5 ml collect from each patient. Sample place in room-temperature centrifuge set to 1600*g for 10 minute. Finally 1.5-2 ml PRP with 4-5 fold concentration and 2000 lymphocyte is ready and for activation add calcium gluconate to it. PRP injection into ovareis under sedation and transvaginal sonography guidance is done (2-4 ml for both ovaries) and serum AMM, estradiol(E2), FSH and LH test every month is measured for two consecutive months.90 days later the second PRP injection is done. 1-year follow up of patients for possible spontaneous regency. Intervention 2: Second intervention group (poor ovarian response): At first test serum AMH, estradiol (E2), FSH and LH a few days before intervention. In intervention day PRP process with Rooyagen kit. Approximately, 8.5 ml collect from each patient. Sample place in room-temperature centrifuge set to 1600*g for 10 minute. Finally 1.5-2 ml PRP with 4-5 fold concentration and 2000 lymphocyte is ready and for activation add calcium gluconate to it. PRP injection into ovareis under sedation and transvaginal sonography guidance is done (2-4 ml for both ovaries) and serum AMM, estradiol(E2), FSH and LH test every month is measured for two consecutive months.90 days later the second PRP injection is done. 1-year follow up of patients for possible spontaneous regency. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the privacy of patients
public Dr.Lida Saeed
Bouali Ave, Safaeih
Yazd Iran (Islamic Republic of) 8916877391 +98 35 3824 7085 lsaeed6@yahoo.com Yazd University of Medical Sciences scientific Dr.Abbas Aflatoonian
Reproductive Science Institute, Bouali Ave, Safaeih
Yazd Iran (Islamic Republic of) 8916877391 +98 35 3824 7085 abbas_aflatoonian@ssu.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) Patient with premature ovarian failure patient with poor ovarian reserve (AFC<5-7 and AMH<0.5-1.1 ng/ml) 20 years 42 years Female IgA deficiency Ovarian failure secondary to sex chromosome abnormality Pelvic adhesion scondary to abdominal surgery Chronic pelvic pain N97.0 N97.0 Female infertility associated with anovulation Female infertility associated with anovulation Treatment - Drugs Treatment - Drugs First intervention group(premature ovarian failure): At first test serum AMH, estradiol (E2), FSH and LH a few days before intervention. In intervention day PRP process with Rooyagen kit. Approximately, 8.5 ml collect from each patient. Sample place in room-temperature centrifuge set to 1600*g for 10 minute. Finally 1.5-2 ml PRP with 4-5 fold concentration and 2000 lymphocyte is ready and for activation add calcium gluconate to it. PRP injection into ovareis under sedation and transvaginal sonography guidance is done (2-4 ml for both ovaries) and serum AMM, estradiol(E2), FSH and LH test every month is measured for two consecutive months.90 days later the second PRP injection is done. 1-year follow up of patients for possible spontaneous regency. Second intervention group (poor ovarian response): At first test serum AMH, estradiol (E2), FSH and LH a few days before intervention. In intervention day PRP process with Rooyagen kit. Approximately, 8.5 ml collect from each patient. Sample place in room-temperature centrifuge set to 1600*g for 10 minute. Finally 1.5-2 ml PRP with 4-5 fold concentration and 2000 lymphocyte is ready and for activation add calcium gluconate to it. PRP injection into ovareis under sedation and transvaginal sonography guidance is done (2-4 ml for both ovaries) and serum AMM, estradiol(E2), FSH and LH test every month is measured for two consecutive months.90 days later the second PRP injection is done. 1-year follow up of patients for possible spontaneous regency. FSH level. Timepoint: Some days before injection and 1, 2 months after injection. Method of measurement: Check in labratory. AMH level. Timepoint: Some days before injection and 1, 2 months after injection. Method of measurement: Check in labratory. Estradiol level. Timepoint: Some days before injection and 1, 2 months after injection. Method of measurement: Check in labratory. LH level. Timepoint: Some days before injection and 1, 2 months after injection. Method of measurement: Check in labratory. Chemical pregnancy. Timepoint: 1 year after the first PRP injection. Method of measurement: Laboratory measurement of Beta hCG. Clinical pregnancy. Timepoint: 5 weeks after positive Beta hCG. Method of measurement: Observation of fetal heart rate in sonography. Live birth. Timepoint: 36 weeks after positive Beta hCG. Method of measurement: Delivery of live-born baby. Yazd University of Medical Sciences Approved 2018-07-21 Ethics committee of reproductive science institute-Yazd Shahid Sadoughi University of Medical Scince Bouali Ave, Safaeih Yazd Yazd Iran (Islamic Republic of)