Poor ovarian response (POR) is a pathological condition where the ovaries do not respond well to the stimulation of gonadotropins. It is mainly characterized by a low number of developing follicles, a high cancellation rate of the ovarian stimulation cycle, a small 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. Novel 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 a prospective randomized controlled trial to evaluate the safety and efficacy of autologous platelet-rich plasma (PRP) local injection therapy for improving ovarian reserve and IVF-ET outcomes in patients with POR and POI. This study is expected to improve the fertility of POR patients from the perspective of autologous cell therapy. The autologous PRP local injection technique does not involve ethical barriers, is easy to standardize the diagnosis and treatment process and operation system, and is suitable for clinical translation and promotion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
142
Under ultrasound guidance, through vaginal puncture, PRP was injected subcutaneously into the ovarian cortex on both sides. There were 3 injection points on each side of the ovary, with 0.5ml injected at each point. The total injection volume for each side of the ovary was 1.5ml. The injection was carried out for 1 to 3 consecutive cycles.
Number of retrieved oocytes
The treatment is considered successful if the number of retrieved oocytes increases by ≥ 2 after the treatment. The effective rate of treatment = (number of effective treatment cycles) / (total number of cycles) × 100%
Time frame: 6 months
Blood anti-Müllerian hormone (AMH) level
Treatment is considered successful if the AMH level rises continuously for two consecutive times. The effective rate of treatment = (number of effective cases) / (total number of cases) × 100%
Time frame: 6 months
Number of antral follicles
The treatment is considered successful if the number of antral follicles in both ovaries increases by ≥ 2 after treatment. The effective rate of treatment = (number of treated cases with effective results) / (total number of treated cases) × 100%
Time frame: 6 months
clinical pregnancy rate
Time frame: 1 year
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