Intraovarian PRP injection for women with poor ovarian response
Effect of Ovarian Injection of Autologous Platelet-Rich Plasma on the Pregnancy Outcome of IVF/ICSI in Patients With Poor Ovarian Response: A Prospective Randomized Controlled Study
This study is testing whether injecting a woman's own platelet-rich plasma (PRP) into her ovaries can help improve egg production for women who have trouble with their ovaries during fertility treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 390 (estimated) |
| Ages | 20 Years to 43 Years |
| Sex | Female |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05601193 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of autologous platelet-rich plasma (PRP) injections on women experiencing poor ovarian response (POR) during artificial reproductive treatment. Participants will be divided into two groups: one receiving the PRP treatment and the other serving as a control. The study aims to assess ovarian reserve function and IVF outcomes before and after the treatment, along with collecting granulosa cells and follicular fluid for further analysis. This prospective randomized controlled trial seeks to fill the gap in existing research on PRP's efficacy in improving ovarian response.
Who should consider this trial
Good fit: Ideal candidates are women under 43 years old with poor ovarian reserve, indicated by low AMH levels and a limited number of follicles.
Not a fit: Patients with clear indications for genetic diagnosis or those with recurrent abortions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance ovarian response and improve IVF outcomes for women with poor ovarian reserve.
How similar studies have performed: While several retrospective studies suggest PRP may be beneficial for POR, this approach is still largely untested in prospective randomized controlled trials.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- Reproductive Medicine Research Center, the Sixth Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Xiaoyan Liang
- Email: liangxy2@mail.sysu.edu.cn
- Phone: 86 020-38250752
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.