A RCT Study on Autologous Cell Injection Into the Ovaries of Patients With POR

A Randomized Controlled Study on Autologous Cell Injection Into the Ovaries of Patients With Poor Ovarian Response

Poor ovarian response (POR) is a pathological state where the ovaries do not respond well to the stimulation of gonadotropins. It is mainly characterized by a small number of developing follicles, a high cancellation rate of the ovarian stimulation cycle, a low 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. New 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 autologous fat vascular matrix components (SVF) or autologous platelet-rich plasma (PRP) local injection therapy for patients with POR and POI, and conduct a prospective exploratory study to evaluate the safety of this clinical technique. Subsequently, a prospective randomized controlled trial will be conducted to evaluate the safety and efficacy of autologous fat vascular matrix components (SVF) or autologous platelet-rich plasma (PRP) local injection therapy in improving ovarian reserve and IVF-ET outcomes. This study is expected to improve the fertility of patients with POR from the perspective of autologous cell therapy. The autologous SVF and PRP local injection techniques do not involve ethical barriers, are easy to standardize the diagnosis and treatment process and operation system, and are suitable for clinical translation and promotion.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 198
• 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
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 22 - 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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group
Experimental: PRP group	Other: PRP injection; Injecting PRP into the ovaries
Experimental: SVF group	Other: SVF injection; Injecting SVF into the ovaries

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of retrieved oocytes	6month

Secondary Outcome Measures

Outcome Measure	Time Frame
clinical pregnancy rate	1 year
anti-Müllerian hormone level	6 month
Number of antral follicles	6 month

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): December 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; autologous fat vascular matrix components
• 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-M20250882; BRWEP2024W094090102 (Other Grant/Funding Number: Beijing Research Ward Excellence Program)

Drug and device information, study documents

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