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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorPeking University Third Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • PRP injection
  • SVF injection

Treatment groups

198 Participants
are divided into 3 treatment groups

Locations

This trial has no locations