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IRCT20080831001141N40 IRCT 2023-01-17 ROYAN Institute Intra-ovarian injection of platelet-rich plasma in patients with poor ovarian response PRP-POR Evaluation of intra-ovarian injection of platelet-rich plasma in patients with poor ovarian response; a randomized controlled clinical trial 2023-02-01 anticipated 200 Complete https://irct.ir/trial/67757 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method is designed by epidemiologist using STATA software version 13 and the number of blocks considered is 8. The random allocation list for patients is solely available to the epidemiologist. In order to hide the random allocation process, a total of 200 envelopes are prepared, and only the methodologist has been aware of table of random numbers. When the doctor declared the patient's eligibility, the methodologist provided the doctor with the envelope. The group will be selected and based on the type of group mentioned in the envelope. N/A Decreased ovarian reserve. Intervention 1: Intervention group: PRP injection will be done on day 8-12 of the menstrual cycle. PRP injection will be performed less than 15 minutes after its preparation by the surgeon and gynecologist. The injection will be done through the vagina, under ultrasound guidance and with a follicle puncture needle (Reproline medical GmbH, single lumen without flushing, 17 GAUGE, D-53359 Rheinbach, Germany). The injection is done under mild anesthesia and takes less than 15 minutes. Intervention 2: Control group: no intervention is done for the patients of this group. Yes - There is a plan to make this available What will be shared: Clinical study report (published article) When: After the publication of the article To whom: Available to the public. Conditions: Scientific use by citing the source. Where to obtain: Dr. Mehri Mashayekhy Email: dr.mashayekhy@yahoo.com How to obtain: Request via e-mail Comments:
public Mehri Mashayekhy
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
Tehran Iran (Islamic Republic of) 148- 16635 +98 21 2356 2647 dr.mashayekhy@yahoo.com ROYAN Institute scientific Mehri Mashayekhy
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
Tehran Iran (Islamic Republic of) 148- 16635 +98 21 2356 2647 dr.mashayekhy@yahoo.com ROYAN Institute Iran (Islamic Republic of) Patients with a history of at least one poor ovarian response Age ≤44 years BMI <35 kg/m2 FSH <25 IU/L AMH <1.2 ng/ml no limit 44 years Female Endocrine, autoimmune and hematological disorders Genetic diseases and chromosomal disorders History of cancer Congenital uterine anomalies Endometriosis, severe adenomyosis, hydrosalpinx, fibromatous uterus N97.9 Female infertility, unspecified Treatment - Other N/A Intervention group: PRP injection will be done on day 8-12 of the menstrual cycle. PRP injection will be performed less than 15 minutes after its preparation by the surgeon and gynecologist. The injection will be done through the vagina, under ultrasound guidance and with a follicle puncture needle (Reproline medical GmbH, single lumen without flushing, 17 GAUGE, D-53359 Rheinbach, Germany). The injection is done under mild anesthesia and takes less than 15 minutes. Control group: no intervention is done for the patients of this group. Increased ovarian reserve: increased number of antral follicles, and increased levels of antimullerin hormone. Timepoint: 6-8 weeks after intraovarian injection of platelet-rich plasma. Method of measurement: Doppler ultrasound and blood test. ROYAN Institute Approved 2022-12-20 Ethics Committee of Royan Institute Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway. Tehran Tehran Iran (Islamic Republic of)