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

NCT07282288 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2025-12-15

No results posted yet for this study

Summary

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.

Conditions

  • Poor Ovarian Response

Interventions

OTHER

PRP injection

Injecting PRP into the ovaries

OTHER

SVF injection

Injecting SVF into the ovaries

Sponsors & Collaborators

  • Peking University Third Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-15
Primary Completion
2027-11-01
Completion
2029-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07282288 on ClinicalTrials.gov