Ovarian PRP Injection in Women With POR

Sun Yat-sen University

Status: Enrolling

Conditions: Poor Ovarian Response

Treatments: Other: autologous platelet-rich plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT05601193

2022ZSLYEC-495

Details and patient eligibility

About

Patients with poor ovarian response (POR）is considered one of most challenging tasks in artificial reproductive treatment (ART). Several retrospective studies have shown that platelet-rich plasma (PRP) is one of the proposed therapeutic strategies for women with POR. However, prospective randomized controlled trials are still lacking. This study aimed to evaluate the effect on intraovarian injection of autologous PRP in poor ovarian reserve prospectively.

Full description

It will be divided two groups of POR patients according to the treatment itself. One group was treated by intraovarian injection of autologous PRP, and the other was control. It will detect the function of ovarian reserve and IVF outcomes before and after treatment in both two groups. In addition, granulosa cells and follicular fluid before and after injection were collected for functional exploration experiments.

Enrollment: 390 estimated patients

Sex: Female

Ages: 20 to 43 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Women less than 43 years old and undergo IVF/ICSI; 2) AMH < 1.1 and the number of follicles in bilateral antrum < 7; 3) those who have obtained less than or equal to 3 follicles in conventional controlled ovulation cycle or whose diameter ≥ 14mm on the trigger day; or have a previous history of ovarian cyst removal; if the woman is less than 40 years old, she needs to meet the inclusion criteria 2 and 3 at the same time. If you are 40 years old or older, you can join the group if you meet the inclusion criteria 2 or 3.

Exclusion criteria

• 1. patients with clear indications or plans to undergo pre-embryo transfer genetic diagnosis (PGD) and preimplantation genetic screening (PGS); 2) patients with recurrent abortion who had more than 2 consecutive spontaneous abortions (including biochemical pregnancy); 3) men with azoospermia who underwent microsemen extraction; 4) benign ovarian cysts (endometriosis cyst, teratoma, etc.) found by B-ultrasound; 5) women with heart, liver and kidney insufficiency. 6) one of the husband and wife has chromosome abnormality; 7) the history of malignant tumor of the woman or the hereditary family history of the husband and wife 8) uterine anatomical abnormalities (including uterine adhesion, endometrial polyps, submucous myoma, uterine mediastinum, etc.) 9) untreated hydrosalpinx 10) uncontrolled endocrine abnormalities, including thyroid dysfunction, diabetes, etc. 11) other reasons that the researchers believe are not appropriate to participate in this study, such as positive for syphilis or HIV.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

390 participants in 2 patient groups

PRP group

Experimental group

Description:

Experimental: autologous PRP Bilateral ovaries autologous PRP injection under transvaginal ultrasound guidance. 3ml on each ovary.Once a month. two consecutive injections

Treatment:

Other: autologous platelet-rich plasma

Control group

No Intervention group

Description:

No intervention