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IRCT20151013024512N7 IRCT 2021-02-11 Deputy of Research and Development, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. Comparison of the effect of PRP versus PRP plus gonadotropin and gonadotropin alone on ovarian rejuvenation in patients with diminished ovarian reserve A comparison of the effect of intraovarian injection of autologous platelet rich plasma (PRP) versus PRP plus gonadotropin and gonadotropin alone on ovarian rejuvenation in patients with diminished ovarian reserve 2021-02-15 anticipated 45 Complete https://irct.ir/trial/53566 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 45 infertile women with diminished ovarian reserve who are referred for infertility treatment will be allocated into three interventional groups via simple, individual randomization method using the table of random numbers. Randomization was previously performed for 45 cases into three groups. This is a not-blinded study. Therefore, the clinician will consecutively assign each woman with the inclusion criteria into one of the three intervention groups for receiving the specific intervention for each group. 2 Ovarian rejuvenation in diminished ovarian reserve patients. Intervention 1: Frist intervention group: 15 infertile women with diminished ovarian reserve aged between 20-48 years were administered by gonadotropin (Cinnal f, 75 IU, CinnaGen Co.) with the dose of 75IU, 1 ampule in each ovary between day 10-14 menstrual cycles. Intervention 2: Second intervention group: 15 infertile women with diminished ovarian reserve aged between 20-48 years were administered by gonadotropin (Cinnal f, 75 IU, CinnaGen Co.) with the dose of 75IU, 1 ampule in each ovary between day 10-14 menstrual cycles PLUS PRP; 17 ml of peripheral venous blood was drawn in the syringe that contained 3 ml of Acid Citrate A Anticoagulant solution (ACD-A) and centrifuged immediately at 1600 g for 10 min. The blood was divided into three layers: red blood cells at the bottom, cellular plasma in the supernatant and a buffy coat layer between them. The plasma layer and buffy coat were collected to another tube and centrifuged again at 3500 g for 5 min to obtain 3 ml PRP. Intervention 3: Intervention group: Third intervention group: 15 infertile women with diminished ovarian reserve aged between 20-48 years were administered PRP alone; 17 ml of peripheral venous blood was drawn in the syringe that contained 3 ml of Acid Citrate A Anticoagulant solution (ACD-A) and centrifuged immediately at 1600 g for 10 min. The blood was divided into three layers: red blood cells at the bottom, cellular plasma in the supernatant and a buffy coat layer between them. The plasma layer and buffy coat were collected to another tube and centrifuged again at 3500 g for 5 min to obtain 3 ml PRP. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Abbas Aflatoonian
Yazd Reproductive Sciences Institute, Bouali Ave, Safaiyeh
Yazd Iran (Islamic Republic of) 8916877391 +98 35 3824 7085 abbas-aflatoonian@ssu.ac.ir Yazd University of Medical Sciences scientific Abbas Aflatoonian
Yazd Reproductive Sciences Institute, Bouali Ave, Safaiyeh
Yazd Iran (Islamic Republic of) 8916877391 035382477085 abbas-aflatoonian@ssu.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) Female infertility Diminish ovarian reserve (AMH<1.1 and AFC< 5-7) 20 to 48 years 20 years 48 years Female Uterin anomaly Polycystic Ovarian Syndrome Male factor Tubal factor E28.3 Primary ovarian failure Treatment - Drugs Treatment - Drugs Treatment - Drugs Frist intervention group: 15 infertile women with diminished ovarian reserve aged between 20-48 years were administered by gonadotropin (Cinnal f, 75 IU, CinnaGen Co.) with the dose of 75IU, 1 ampule in each ovary between day 10-14 menstrual cycles. Second intervention group: 15 infertile women with diminished ovarian reserve aged between 20-48 years were administered by gonadotropin (Cinnal f, 75 IU, CinnaGen Co.) with the dose of 75IU, 1 ampule in each ovary between day 10-14 menstrual cycles PLUS PRP; 17 ml of peripheral venous blood was drawn in the syringe that contained 3 ml of Acid Citrate A Anticoagulant solution (ACD-A) and centrifuged immediately at 1600 g for 10 min. The blood was divided into three layers: red blood cells at the bottom, cellular plasma in the supernatant and a buffy coat layer between them. The plasma layer and buffy coat were collected to another tube and centrifuged again at 3500 g for 5 min to obtain 3 ml PRP Intervention group: Third intervention group: 15 infertile women with diminished ovarian reserve aged between 20-48 years were administered PRP alone; 17 ml of peripheral venous blood was drawn in the syringe that contained 3 ml of Acid Citrate A Anticoagulant solution (ACD-A) and centrifuged immediately at 1600 g for 10 min. The blood was divided into three layers: red blood cells at the bottom, cellular plasma in the supernatant and a buffy coat layer between them. The plasma layer and buffy coat were collected to another tube and centrifuged again at 3500 g for 5 min to obtain 3 ml PRP Increase Anti-Müllerian hormone level. Timepoint: At the beginning of the study, every month up to 3 months. Method of measurement: Lab Test. Antral follicular count. Timepoint: 1 to 4 months later. Method of measurement: Transvaginal sonography. Spontaneous pregnancy. Timepoint: 3 months later. Method of measurement: Lab test. Entering assisted reproductive cycle. Timepoint: Once the AMH increases or the patient insists on doing assisted reproductive cycle. Method of measurement: Lab test. Deputy of Research and Development, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. Approved 2020-07-19 The Ethics Committee of Yazd Reproductive Sciences Institute, Yazd Shahid Sadoughi University of Med Bouali Ave, Safaiyeh,Reproductive Sciences Institute Yazd Yazd Iran (Islamic Republic of)