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NCT Number: NCT07282288

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

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.

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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 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
  • 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.

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

Other

Injecting PRP into the ovaries

SVF injection

Other

Injecting SVF into the ovaries

Primary outcomes

  1. Number of retrieved oocytes

    Time frame: 6month

Secondary outcomes

  1. anti-Müllerian hormone level

    Time frame: 6 month

  2. Number of antral follicles

    Time frame: 6 month

  3. 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 Cell Injection Into the Ovaries of 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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