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

NCT07282288 | Not Yet Recruiting

• 2 other identifiers: IRB00006761-M20250882BRWEP2024W094090102
• Study Type: interventional
• Target: 198
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Poor ovarian response; Premature ovarian insufficiency; autologous fat vascular matrix components; autologous platelet-rich plasma

Outcome Measures

Primary Outcomes (1)

• Number of retrieved oocytes

  6month

Secondary Outcomes (3)

• anti-Müllerian hormone level

  6 month

• Number of antral follicles

  6 month

• clinical pregnancy rate

  1 year

Study Arms (3)

PRP group

EXPERIMENTAL

Other: PRP injection

SVF group

EXPERIMENTAL

Other: SVF injection

Control Group

NO INTERVENTION

Interventions

PRP injection OTHER

Injecting PRP into the ovaries

PRP group

SVF injection OTHER

Injecting SVF into the ovaries

SVF group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women who have fertility requirements and are seeking IVF treatment
• 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 22 - 29 kg/m²
• Participants must have given informed consent for this study and voluntarily signed a written informed consent form.

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 15, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2029
• Last Updated: December 15, 2025

Record last verified: 2025-12