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Not Yet RecruitingNCT07282314

A RCT Study on Autologous PRP Injection in Patients With POR

A Randomized Controlled Study on Autologous Platelet-rich Plasma Injection in Patients With Poor Ovarian Response

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
142 (estimated)
Sponsor
Peking University Third Hospital · Academic / Other
Sex
Female
Age
18 Years – 45 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DEVICEPRP injectionUnder 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.

Timeline

Start date
2025-12-15
Primary completion
2027-11-01
Completion
2029-11-01
First posted
2025-12-15
Last updated
2025-12-15

Source: ClinicalTrials.gov record NCT07282314. Inclusion in this directory is not an endorsement.