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IRCT20160722029027N15 IRCT 2025-08-26 Shahid Beheshti University of Medical Sciences Studying the effectiveness of vaginal radiofrequency on ovarian reserve in people with reduced ovarian reserve : Comparison the effect of ovarian PRP with and without vaginal RF on the number of oocyte and embryos in patients with diminished ovarian reserve and candidates for IVF 2025-08-03 anticipated 60 Recruiting https://irct.ir/trial/82943 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: The present study is the first to evaluate the effect of ovarian PRP with and without vaginal RF on the number of eggs and embryos in individuals with DOR and candidates for IVF, Randomization description: Random assignment of individuals to the intervention and control groups will be done as described using cards placed inside Sequentially Numbered Sealed Opaque Envelopes (SNOSE). These cards will be prepared in the same number as the intervention and control groups (e.g., cards numbered one for the intervention group and numbered two for the control group) and will be placed inside the sealed opaque envelopes. After shuffling the envelopes, each person meeting the inclusion criteria will select an envelope to determine their study group, Blinding description: Individuals from the research team who are involved in the random assignment and intervention ( PRP with and without vaginal radioferquency) will not be involved in examining the study outcomes (dependent variables). 3 Decreased ovarian reserve. Intervention 1: Intervention group:The intervention group includes people who undergo vaginal RF in addition to ovarian PRP. First, patients enter an IVF cycle with a fixed protocol, and simultaneously with ovarian puncture and egg extraction, ovarian PRP is performed in such a way that a sample is prepared from the individual's peripheral blood and blood platelets are extracted 4-5 times and injected in an amount of 1.5 cc into each ovary. The number of eggs and embryos obtained in both groups is recorded. Then, in the intervention group, they undergo vaginal RF in 4 sessions over a period of 2 months. In these patients, RF is performed in the form of capacitive electrical transmission, in a monopolar configuration, which has two electrodes, one placed in the vaginal area and the other in the lumbosacral area. Participants are placed in the supine position. The temperature will be set to 45 degrees Celsius, with a frequency of 1 MHz and a power of 80 kilojoules. Once the desired temperature is reached, the interventional researcher holds it in a semicircular motion on the lateral walls of the vagina for 30 minutes. Each patient will undergo RF treatment for 4 sessions at 2-week intervals over 2 months. Both groups will be re-entered into the IVF cycle and the number of oocytes and embryos retrieved will be recorded. Finally, the average number of oocytes and embryos in both groups before and after vaginal RF is compared. After the treatment period, patients will be evaluated for the following outcomes: 1) number of oocytes retrieved and 2) number of embryos retrieved, 3) any unwanted treatment complications during treatment, and 4) patient satisfaction with the treatment protocol on a five-level scale of completely dissatisfied, somewhat dissatisfied, no opinion, somewhat satisfied, and completely satisfied. Intervention 2: Control group: In the control group, ovarian PRP is performed without vaginal RF. In this way, patients enter the IVF cycle with a fixed protocol, and simultaneously with ovarian puncture and egg extraction, ovarian PRP is performed in this way that a sample is prepared from the individual's peripheral blood and blood platelets are extracted 4-5 times and injected in an amount of 1.5 cc into each ovary. The number of eggs and embryos obtained is recorded. In this group, the vaginal RF maneuver is also performed every 2 weeks, but in a simulated manner and without turning on the device. Then, both groups are entered into the IVF cycle again, and the number of eggs and embryos obtained is recorded. Finally, the average number of eggs and embryos in both groups before and after vaginal RF is compared with each other. After the treatment period, patients are evaluated for the following outcomes: 1) number of oocytes retrieved, 2) number of embryos obtained, 3) any unwanted treatment complications during treatment, and 4) patient satisfaction level with the treatment protocol on a five-level scale of completely dissatisfied, somewhat dissatisfied, no opinion, somewhat satisfied, and completely satisfied. 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 No more information available.
public Leila Nazari
Tajrish
Tehran Iran (Islamic Republic of) 1234567890 +98 912 316 4282 nazari@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific leila nazari
Tajrish
Tehran Iran (Islamic Republic of) 1234567890 +98 912 316 4282 nazari@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Having diminished ovarian reserve as defined by an antral follicle count or AFC of less than 5 to 7 follicles and an AMH level of less than 1.1 ng/ml who presented for infertility. Normal vaginal endocytology without any evidence of malignancy with atypia. Not receiving hormone replacement therapy for six months, no pacemaker or any metal device in the pelvic area. 25 years 45 years Female For any reason, the patient is unwilling to participate in the study. Treatment - Devices Treatment - Devices Intervention group:The intervention group includes people who undergo vaginal RF in addition to ovarian PRP. First, patients enter an IVF cycle with a fixed protocol, and simultaneously with ovarian puncture and egg extraction, ovarian PRP is performed in such a way that a sample is prepared from the individual's peripheral blood and blood platelets are extracted 4-5 times and injected in an amount of 1.5 cc into each ovary. The number of eggs and embryos obtained in both groups is recorded. Then, in the intervention group, they undergo vaginal RF in 4 sessions over a period of 2 months. In these patients, RF is performed in the form of capacitive electrical transmission, in a monopolar configuration, which has two electrodes, one placed in the vaginal area and the other in the lumbosacral area. Participants are placed in the supine position. The temperature will be set to 45 degrees Celsius, with a frequency of 1 MHz and a power of 80 kilojoules. Once the desired temperature is reached, the interventional researcher holds it in a semicircular motion on the lateral walls of the vagina for 30 minutes. Each patient will undergo RF treatment for 4 sessions at 2-week intervals over 2 months. Both groups will be re-entered into the IVF cycle and the number of oocytes and embryos retrieved will be recorded. Finally, the average number of oocytes and embryos in both groups before and after vaginal RF is compared. After the treatment period, patients will be evaluated for the following outcomes: 1) number of oocytes retrieved and 2) number of embryos retrieved, 3) any unwanted treatment complications during treatment, and 4) patient satisfaction with the treatment protocol on a five-level scale of completely dissatisfied, somewhat dissatisfied, no opinion, somewhat satisfied, and completely satisfied. Control group: In the control group, ovarian PRP is performed without vaginal RF. In this way, patients enter the IVF cycle with a fixed protocol, and simultaneously with ovarian puncture and egg extraction, ovarian PRP is performed in this way that a sample is prepared from the individual's peripheral blood and blood platelets are extracted 4-5 times and injected in an amount of 1.5 cc into each ovary. The number of eggs and embryos obtained is recorded. In this group, the vaginal RF maneuver is also performed every 2 weeks, but in a simulated manner and without turning on the device. Then, both groups are entered into the IVF cycle again, and the number of eggs and embryos obtained is recorded. Finally, the average number of eggs and embryos in both groups before and after vaginal RF is compared with each other. After the treatment period, patients are evaluated for the following outcomes: 1) number of oocytes retrieved, 2) number of embryos obtained, 3) any unwanted treatment complications during treatment, and 4) patient satisfaction level with the treatment protocol on a five-level scale of completely dissatisfied, somewhat dissatisfied, no opinion, somewhat satisfied, and completely satisfied. Number of oocyte. Timepoint: Before and after vaginal RF. Method of measurement: Counting with a microscope. Number of embryo. Timepoint: Before and after vaginal RF. Method of measurement: Counting with a microscope. Shahid Beheshti University of Medical Sciences Approved 2025-08-02 Shahid Beheshti University of Medical Sciences ethics committee Ghadir building,Shohadaye Tajrish hospital,Qods square,Tajrish Tehran Tehran Iran (Islamic Republic of)