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IRCT20160815029374N7 IRCT 2019-06-20 Mazandaran University of Medical Sciences Platelet-rich plasma effect in infertility The effect of intraovarian injection of Calcium Gluconate-activated platelet-rich plasma (PRP) on infertile women with diminished ovarian reserve: A before after clinical trial 2019-01-29 anticipated 10 Complete https://irct.ir/trial/39126 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Diseases of the genitourinary system. Intervention group: Intrauterine infusion of 0.5 CC of autologus Calcium Gluconate- activated platelet-rich plasma (has 4-6 times platelet concentration rather than peripheral blood by IUI catheter(Takvin company, Iran) on day of oocyte pick up.. 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 There is no information
public Marzieh Zamaniyan
No. 1, First floor, Infertility ward, Imam Khomeini Hospital, Amir Mazandarani Ave,
Sari Iran (Islamic Republic of) 331314816 +98 11333661700 marziehzamaniyan@gmail.com Mazandaran University of Medical Sciences scientific Marzieh Zamaniyan
No. 1, First floor, Infertility ward, Imam Khomeini Hospital, Amir Mazandarani Ave,
Sari Iran (Islamic Republic of) 3313148166 +98 11333661700 marziehzamaniyan@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Diminished ovarian reserve At least one prior failed in vitro fertilization Body mass index lower than 30 Kilogram per square meter Premature ovarian failure 20 years 45 years Female Hematologic disorders (blood cancer, thrombocytopenia) Immunologic disorders (anti-phospholipid syndrome, thrombophilia) Hormonal disorders (diabetes, thyroid, hyperprolactinemia) Chromosomal anomalies and genetics (herditary or congenital) Renal failure N97; N98 Female infertility; Complications associated with artificial fertilization Treatment - Drugs Intervention group: Intrauterine infusion of 0.5 CC of autologus Calcium Gluconate- activated platelet-rich plasma (has 4-6 times platelet concentration rather than peripheral blood by IUI catheter(Takvin company, Iran) on day of oocyte pick up. Change in Anti mulerian hormone level. Timepoint: Two weeks after oocyte pick up compared with two week before injection of of Calcium Gluconate-activated platelet-rich plasma (the day of pick up oocyte). Method of measurement: Assaying this factor in blood serum is done by laboratory methods and the corresponding kit. Changes in the level of follicular stimulating hormone. Timepoint: Two weeks after oocyte pick up compared with two week before injection of of Calcium Gluconate-activated platelet-rich plasma (the day of pick up oocyte). Method of measurement: Assaying this factor in blood serum is done by laboratory methods and the corresponding kit. Change in estradiol level. Timepoint: Two weeks after oocyte pick up compared with two week before injection of of Calcium Gluconate-activated platelet-rich plasma (the day of pick up oocyte). Method of measurement: Assaying this factor in blood serum is done by laboratory methods and the corresponding kit. Change in Antral fulicular counts. Timepoint: The third day of menstruation and before B-HCG injection. Method of measurement: by ultrasound and folliculography. Change in oocyte numbers. Timepoint: Two months after Calcium Gluconate- activated platelet-rich plasma injection comparison with the day of Oocyte pick up. Method of measurement: evaluation by microscope and ultrasound. Pregnancy rate. Timepoint: Three monthes after Calcium Gluconate - activated platelet-rich plasma injection then survey chemical and clinical pregnancy. Method of measurement: Positive beta hCG rate and clinical pregnancy rates. Change in embryos numbers. Timepoint: Two months after intraovarian injection of platelet. Method of measurement: by counting frozen embryo in embryo bank. Mazandaran University of Medical Sciences Approved 2019-01-28 Ethics committee of Mazandaran University of Medical Sciences No. 5, third floor, Cancer ward, Imam Khomeini Hospital, Amir Mazandarani Ave, Diabetes Research Center. Sari Mazandaran Iran (Islamic Republic of)