A RCT Study on Autologous Cell Injection Into the Ovaries of Patients With POR
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PRP injection, SVF injection.
- Who it may be relevant to
- Registry conditions: Poor Ovarian Response. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Controlled Study on Autologous Cell Injection Into the Ovaries of Patients With Poor Ovarian Response
Overview
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.
Interventions
- Other PRP injection
Injecting PRP into the ovaries - Other SVF injection
Injecting SVF into the ovaries
Primary outcome measures
- Number of retrieved oocytes [Time frame: 6month]
Secondary outcome measures (3)
- anti-Müllerian hormone level [Time frame: 6 month]
- Number of antral follicles [Time frame: 6 month]
- clinical pregnancy rate [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07282288 · IRB00006761-M20250882 · BRWEP2024W094090102