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IRCT20181030041503N12 IRCT 2026-01-01 Mashhad University of Medical Sciences Effect of intraovarian injection of platelet-rich plasma in women with poor ovarian response Assessment of the effect of intraovarian platelet-rich plasma (PRP) injection on the results of assisted reproductive methods in infertile women with poor ovarian response (Poseidon 1, 2, 3,4) 2025-10-23 anticipated 64 Recruiting https://irct.ir/trial/85996 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the random allocation sequence of individuals to the study groups was generated using the permuted block method. The random allocation sequence was performed using the Random Allocation Software with a block size of four. The permuted block method is one of the random allocation techniques in which each block is selected to be the size of the number of study groups. For allocation concealment, sealed envelopes were used. Based on the order of entry of the research units, the envelopes were opened sequentially, and the assigned group was revealed. N/A Infertility. Intervention 1: In the intervention group, 60 cc of blood is collected from each participant, and platelet-rich plasma with a concentration of 4-5 times baseline is prepared using the Royagen kit (approved by the Ministry of Health). Then, 1.5 to 2 cc of PRP is injected into each ovary under anesthesia and ultrasound guidance on days 7 to 10 of the menstrual cycle. The injection is repeated in two consecutive cycles. In the third month, the patient begins ovarian stimulation with gonadotropin drugs at a dose of 225 units of Sinal F and 150 units of HMG on the second day of the cycle. The drug dose is adjusted based on ultrasound findings. When the follicle reaches 14 mm, sterotide is started. When two 16 mm follicles are observed in the ovary, a trigger is performed with a GnRH agonist. Ovulation is performed 36 hours later. Simultaneously with ovulation, PRP is performed in the ovary again. After 3 days, ovarian stimulation with gonadotropin is started again, and the re-stimulation cycle is repeated. And ovulation is performed again. Intervention 2: In the control group, ovarian stimulation is performed with the same gonadotropin protocol (Gonal-F and HMG), followed by Cetrotide and GnRH agonist trigger as indicated. Oocyte retrieval is performed and resulting embryos are cryopreserved. No PRP injection is performed in this group. No - There is not a plan to make this available Justification or reason for not sharing IPD is I'm looking into the matter
public Malihe Mahmoudinia
Milad Infertility Center, Imam Reza Hospital, Daneshgah Street, Mashhad
Mashhad Iran (Islamic Republic of) 9178943791 +98 915 304 7813 mahmoudiniam@mums.ac.ir Mashhad University of Medical Sciences scientific Malihe Mahmoudinia
Milad Infertility Center, Imam Reza Hospital, Daneshgah Street, Mashhad
Mashhad Iran (Islamic Republic of) 9178943791 +98 915 304 7813 mahmoudiniam@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Women with poor ovarian response, which includes patients who had less than or equal to 4 oocytes retrieved in a previous IVF cycle Anti-Mullerian Hormone (AMH) less than 1.2 ng/mL Antral follicle count (AFC) less than 5 follicles in both ovaries on ultrasound on the third day of the period Regular menstruation every 24-35 days 21 years 42 years Female Presence of severe endometriosis, grade 3 and 4. Presence of severe adenomyosis. Presence of a uterine anomaly. Presence of a chromosomal abnormality in the karyotype of either the woman or the man. A medical history that includes uncontrolled hypertension, thrombotic disease, or uncontrolled diabetes. N97.9 Female infertility, unspecified Treatment - Surgery Placebo In the intervention group, 60 cc of blood is collected from each participant, and platelet-rich plasma with a concentration of 4-5 times baseline is prepared using the Royagen kit (approved by the Ministry of Health). Then, 1.5 to 2 cc of PRP is injected into each ovary under anesthesia and ultrasound guidance on days 7 to 10 of the menstrual cycle. The injection is repeated in two consecutive cycles. In the third month, the patient begins ovarian stimulation with gonadotropin drugs at a dose of 225 units of Sinal F and 150 units of HMG on the second day of the cycle. The drug dose is adjusted based on ultrasound findings. When the follicle reaches 14 mm, sterotide is started. When two 16 mm follicles are observed in the ovary, a trigger is performed with a GnRH agonist. Ovulation is performed 36 hours later. Simultaneously with ovulation, PRP is performed in the ovary again. After 3 days, ovarian stimulation with gonadotropin is started again, and the re-stimulation cycle is repeated. And ovulation is performed again. In the control group, ovarian stimulation is performed with the same gonadotropin protocol (Gonal-F and HMG), followed by Cetrotide and GnRH agonist trigger as indicated. Oocyte retrieval is performed and resulting embryos are cryopreserved. No PRP injection is performed in this group Number of follicles developed. Timepoint: Trigger injection day. Method of measurement: Transvaginal ultrasound. Total number of oocytes retrieved on the day of ovulation. Timepoint: On the day of Ovum Pick Up. Method of measurement: Examination by an embryologist. Number of grade 1 and 2 embryos. Timepoint: 2-5 days after ovulation. Method of measurement: Examination by an embryologist. Chemical pregnancy: positive β-HCG test greater than 25 mIU/ml after 12–16 days from embryo transfer. Timepoint: 12–16 days after embryo transfer. Method of measurement: Serum β‑human chorionic gonadotropin (β‑hCG) measurement using quantitative immunoassay. Clinical pregnancy rate. Timepoint: 6 weeks after transfer. Method of measurement: Ultrasound examination. Ongoing Pregnancy Rate. Timepoint: At 12weeks after embryo transfer. Method of measurement: Ultrasound examination. Miscarriage rate. Timepoint: Before 20 weeks of pregnancy. Method of measurement: Ultrasound examination. Mashhad University of Medical Sciences Approved 2025-06-07 Ethics committee of Mashhad university of Medical Sciences Imam Reza Hospital, Imam Reza St., Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)