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NCT05601193
Ovarian PRP Injection in Women With POR
Conditions: Poor Ovarian Response
Sex: Female
Ages: 20 Years – 43 Years
Phase: NA
Enrollment: 390
Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Location: China
Summary
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT05601193). StuddyBuddy aggregates publicly available trial information.