Using Platelet-rich Plasma to Improve Female Fertility

Application of Platelet-rich Plasma (PRP) in Reproductive Medicine

This study is testing whether injections of platelet-rich plasma can help improve fertility in women dealing with issues like poor ovarian response and repeated implantation failure.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 50 Years
• Sex: Female
• Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine (Academic / other)
• Locations: 1 site (Yiwu, Zhejiang)
• Trial ID: NCT06645379 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of platelet-rich plasma (PRP) injections to treat various conditions affecting female fertility, including premature ovarian insufficiency, intrauterine adhesion, poor ovarian response, repeated implantation failure, and thin endometrium. The study aims to explore the therapeutic effects and potential mechanisms of PRP in addressing these fertility-related issues, which currently lack effective treatments. By focusing on the ovaries and endometrium, the trial seeks to provide a novel approach to enhance reproductive outcomes for women facing these challenges.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 18 to 40 with conditions such as premature ovarian insufficiency or poor ovarian response.

Not a fit: Patients who do not meet the eligibility criteria or have other underlying reproductive health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve fertility outcomes for women suffering from specific reproductive health issues.

How similar studies have performed: Previous studies have shown promise in using platelet-rich plasma for similar fertility-related conditions, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Premature ovarian insufficiency: ① Women aged \>18 and \<40 years old; ② Oligomenorrhea or amenorrhea for more than 4 months (excluding pregnancy); ③ Basal follicle stimulating hormone (FSH) \>25IU/L (interval \>4 weeks) at least 2 times, or total antral follicles (AFC) \<5, or anti-Mullerian hormone (AMH) \<1.1ng/mL.
* Poor ovarian response: ① Advanced age (≥40 years) or other risk factors for poor ovarian response; ② Poor ovarian response in previous IVF cycle, with ≤3 oocytes retrieved using conventional protocols; ③ Decreased ovarian reserve (antral follicle count \<5\~7 or anti-Müllerian hormone \<0.5\~1.1 ug/L). Meeting any 2 of the above 3 criteria is sufficient.
* Intrauterine adhesion: ① Diagnosed by hysteroscopy and scored ≥5 points according to the American Fertility Society criteria (1988); ② With symptoms such as reduced menstrual flow amenorrhea, periodic lower abdominal pain, infertility, or recurrent miscarriage; ③ Adult women with the desire to conceive.
* Thin endometium: ①Endometrial thickness \<7mm on ovulation day or on the day of human chorionic gonadotropin (HCG) injection, or \<7mm on progesterone conversion day when using conventional hormone replacement therapy, ②adult women with the desire to comceive.
* Repeated implantation failure: Women under 40 years old who have failed to achieve clinical pregnancy after transplanting at least three high-quality embryos within three fresh or frozen cycles. High-quality embryos include: Day 3 embryos (with ≥8 cells, evenly sized blastomeres, and \<10% fragmentation) and blastocysts (≥3BB).

Exclusion Criteria:

* Alanine aminotransferase \> 3 times the normal upper limit or estimated glomerular filtration rate (EGFR) \< 90 ml/min;
* Suffering from hemorrhagic diseases (such as hemophilia) or taking anticoagulant or antiplatelet drugs;
* Suffering from serious mental illness, cardiovascular and cerebrovascular diseases and malignant tumors;
* Suffering from diabetes with poor blood sugar control or other systemic diseases;
* Drug abuse, alcoholism or drug addiction;
* Participated in other interventional clinical studies within half a year;
* Poor compliance;
* Other circumstances that are not suitable for participating in the study.

Where this trial is running

Yiwu, Zhejiang

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine — Yiwu, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Youhua Lai

Conditions Premature Ovarian Insufficiency; Intrauterine Adhesion; Poor Ovarian Response; Repeated Implantation Failure; Thin Endometrium