A RCT Study on Autologous PRP Injection in Patients With POR

A Randomized Controlled Study on Autologous Platelet-rich Plasma Injection in Patients With Poor Ovarian Response

Poor ovarian response (POR) is a pathological condition where the ovaries do not respond well to the stimulation of gonadotropins. It is mainly characterized by a low number of developing follicles, a high cancellation rate of the ovarian stimulation cycle, a small number of retrieved oocytes, and a low clinical pregnancy rate. Premature ovarian insufficiency (POI) is a special type of this condition and is one of the most difficult infertility diseases to treat. The incidence of POR and POI in reproductive-aged women in China is increasing year by year, making them key and challenging issues in reproductive medicine. Novel local ovarian cell therapy can improve the microenvironment for follicle development, promote the development and ovulation of "dormant" primordial follicles, and improve the quality of oocytes. This study intends to conduct a prospective randomized controlled trial to evaluate the safety and efficacy of autologous platelet-rich plasma (PRP) local injection therapy for improving ovarian reserve and IVF-ET outcomes in patients with POR and POI. This study is expected to improve the fertility of POR patients from the perspective of autologous cell therapy. The autologous PRP local injection technique does not involve ethical barriers, is easy to standardize the diagnosis and treatment process and operation system, and is suitable for clinical translation and promotion.

Study Overview

• Status: Not yet recruiting
• Conditions: Poor Ovarian Response; PRP Injection
• Intervention / Treatment: Device: PRP injection

• Study Type: Interventional
• Enrollment (Estimated): 142
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Women who have fertility requirements and are seeking IVF treatment at the Reproductive Medicine Center of Peking University Third Hospital
2. Age ≤ 45 years old, infertility duration ≥ 1 year
3. Meeting the diagnostic criteria for POI or the Poseidon diagnostic criteria for POR
4. Previous controlled ovarian stimulation resulted in no more than 3 oocytes retrieved and/or no transplantable embryos and/or previous embryo implantation failure ≥ 2 times
5. Uterus and bilateral adnexa are intact
6. BMI 18.5 - 29 kg/m²
7. Participants must have given informed consent for this study and voluntarily signed a written informed consent form.

Exclusion Criteria:

1. Congenital abnormalities of reproductive organs
2. Septicemia, platelet dysfunction syndrome and severe thrombocytopenia and other coagulation disorders or other hematological diseases
3. Suffering from autoimmune diseases or other endocrine disorders, with abnormal thyroid function and uncontrolled condition
4. Having a mass in the adnexal area with an unclear benign or malignant nature
5. Complicated with severe cardiovascular and cerebrovascular diseases, malignant tumors, hematological diseases and mental disorders, patients with impaired function of important organs
6. Those who have used systemic corticosteroids within the last 2 weeks, or used antiplatelet drugs such as aspirin within the last 48 hours
7. In the acute inflammatory stage
8. Those with a history of venous thrombosis or pulmonary embolism during the screening period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; No intervention
Experimental: PRP group; Under ultrasound guidance, through vaginal puncture, PRP was injected subcutaneously into the ovarian cortex on both sides. There were 3 injection points on each side of the ovary, with 0.5ml injected at each point. The total injection volume for each side of the ovary was 1.5ml. The injection was carried out for 1 to 3 consecutive cycles.	Device: PRP injection; Under ultrasound guidance, through vaginal puncture, PRP was injected subcutaneously into the ovarian cortex on both sides. There were 3 injection points on each side of the ovary, with 0.5ml injected at each point. The total injection volume for each side of the ovary was 1.5ml. The injection was carried out for 1 to 3 consecutive cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of retrieved oocytes	The treatment is considered successful if the number of retrieved oocytes increases by ≥ 2 after the treatment. The effective rate of treatment = (number of effective treatment cycles) / (total number of cycles) × 100%	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood anti-Müllerian hormone (AMH) level	Treatment is considered successful if the AMH level rises continuously for two consecutive times. The effective rate of treatment = (number of effective cases) / (total number of cases) × 100%	6 months
Number of antral follicles	The treatment is considered successful if the number of antral follicles in both ovaries increases by ≥ 2 after treatment. The effective rate of treatment = (number of treated cases with effective results) / (total number of treated cases) × 100%	6 months
clinical pregnancy rate		1 year

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2029

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: December 2, 2025
• First Posted (Actual): December 15, 2025

Study Record Updates

• Last Update Posted (Actual): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: poor ovarian response; Premature ovarian insufficiency; autologous platelet-rich plasma
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Primary Ovarian Insufficiency
• Other Study ID Numbers: IRB00006761-M20250889

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No