Investigation of the Effect of Platelet-Rich Plasma (PRP) Injection into the Ovary on Improving Ovarian Response and Oocyte Quality in Patients with Poor Ovarian Response

To determine the effect of intraovarian platelet-rich plasma injection on ovarian response in women with poor ovarian response

Prospective, randomized, double-blind, placebo-controlled, parallel-group, single-center clinical trial involving 200 participants.

This study will be conducted at Fatemeh Zahra Infertility Center in Babol. The intervention group will receive a single 1–2 mL intraovarian injection of platelet-rich plasma, while the control group will receive the same volume of sterile normal saline under transvaginal ultrasound guidance. The injection team will be aware of group allocation, whereas participants, outcome assessors, and the data analyst will be blinded.

Inclusion criteria: Women aged 30–45 years with poor ovarian response according to the Bologna criteria, no pregnancy during the previous 12 months, a body mass index of 18–30 kg/m², and willingness to provide written informed consent. Exclusion criteria: Conditions that may increase the risk of the intervention or interfere with treatment or study outcomes, including autoimmune or coagulation disorders, active infection, malignancy, current pregnancy, use of potentially interfering medications such as long-term corticosteroids, previous ovarian surgery, or any medical condition that makes intraovarian injection or continuation of infertility treatment inappropriate.

The intervention group will receive a single intraovarian injection of 1–2 mL of platelet-rich plasma into the cortex of each ovary. The control group will undergo the same injection procedure and receive 1–2 mL of sterile normal saline. The injection will be performed under local anesthesia with transvaginal ultrasound guidance. Participants will be observed for 30 minutes after the procedure.

Number of retrieved oocytes per participant

Eligible participants will be randomly assigned individually to either the intervention or control group in a 1:1 ratio. Block randomization with fixed blocks of four will be used to maintain a balanced allocation between the two groups throughout the recruitment period. No stratification will be used. The randomization sequence will be generated using a computer-generated randomization procedure by an independent researcher who will have no involvement in participant recruitment, administration of the intervention, outcome assessment, or data analysis. The sequence will consist of randomly ordered intervention and control assignments within blocks of four. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes prepared by a researcher who is independent of the recruitment and assessment processes. After a participant meets all eligibility criteria and provides written informed consent, the next envelope in sequence will be opened to determine the assigned group. Thus, the allocation sequence will not be accessible to the investigators responsible for participant recruitment or baseline assessment before assignment.

In this trial, participants and outcome assessors will be blinded to participants’ group allocation. The data analyst will also remain blinded to group allocation until the statistical analysis has been completed and the data have been finalized. To maintain participant blinding, participants in the control group will undergo the same transvaginal, ultrasound-guided intraovarian injection procedure as those in the intervention group under sterile conditions. However, sterile saline will be injected instead of platelet-rich plasma. Thus, the procedure and its appearance will be similar in both groups, and participants will not be informed about the substance injected or their group allocation. The physician or members of the healthcare team performing the injection will be aware of the group allocation because this information is necessary to administer the assigned intervention correctly. However, these individuals will not participate in outcome assessment or data analysis. Outcome assessors and data collectors will, as far as possible, remain blinded to participants’ group allocation, and information regarding the type of intervention will not be made available to them. Data analysis will be performed by an analyst who will not have access to group allocation before the statistical analysis is completed. The principal investigator will remain blinded to participants’ group allocation during participant allocation and intervention procedures whenever knowledge of the assigned intervention is not necessary. If knowledge of group allocation is required to ensure the correct implementation of the intervention, this information will be available only to the personnel responsible for administering the intervention. The results will be reported and the manuscript will be prepared using coded data. Whenever possible, the manuscript writers will remain unaware of the identity of the study groups until the statistical analysis has been finalized.

Deidentified Individual Participant Data (IPD) – This includes all deidentified participant data related to primary and secondary outcome measures, collected through questionnaires and clinical records. Study Protocol – Full finalized protocol submitted to the ethics committee. Statistical Analysis Plan (SAP) – Final version describing the statistical methods used for primary and secondary outcomes. Informed Consent Form – Blank version of the informed consent form used for participant enrollment. Analytic Code – R/Stata/SPSS scripts used for statistical analysis. Data Dictionary – A detailed guide to the variables, definitions, formats, and codes used in the dataset

The documents and data files will be available starting 6 months after the main publication and will remain accessible for at least 5 years.

Data and documents will be made available to researchers affiliated with academic or nonprofit institutions, with a clear and valid research purpose. Requests from commercial entities may be considered case-by-case.

Data/documents can be used only for secondary analyses related to reproductive health, fertility, or public health. Proposals will be reviewed by the principal investigator and research ethics coordinator. Data will be shared via secure data transfer.

Requests should be directed via email to: Dr. Fatemeh Bakouei Babol University of Medical Sciences Email:dr.f.amirkhanloo83@gmail.com

Interested researchers should submit: A short proposal (max 1 page) Ethics approval (if applicable) Signed data use agreement Requests will be reviewed within 2–4 weeks. Access will be granted after approval and agreement signature.

None at this time.