A RCT Study on Autologous PRP Injection in Patients With POR

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.

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Key information

Conditions

Poor Ovarian Response Adnexal Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Ovarian Diseases PRP Injection Primary Ovarian Insufficiency Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women who have fertility requirements and are seeking IVF treatment at the Reproductive Medicine Center of Peking University Third Hospital
Age ≤ 45 years old, infertility duration ≥ 1 year
Meeting the diagnostic criteria for POI or the Poseidon diagnostic criteria for POR
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
Uterus and bilateral adnexa are intact
BMI 18.5 - 29 kg/m²
Participants must have given informed consent for this study and voluntarily signed a written informed consent form.

Exclusion criteria

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

Treatment and study plan

PRP injection

Device

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.

Primary outcomes

Number of retrieved oocytes

Time frame: 6 months

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%

Secondary outcomes

Blood anti-Müllerian hormone (AMH) level

Time frame: 6 months

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%
Number of antral follicles

Time frame: 6 months

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%
clinical pregnancy rate

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2029
First posted: Dec 15, 2025
Registry last updated: Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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