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NCT Number: NCT06645379

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

Female fertility is affected by many factors, such as ovarian function, fallopian tube patency, uterine environment, and mental state, among which the ovaries and endometrium are more important. In reproductive medicine, ovarian dysfunction, poor ovarian reaction, intrauterine adhesion, recurrent implantation failure, and thin endometrium are the five most common diseases that affect fertility. These five diseases lack effective treatment, and previous studies have shown that platelet-rich plasma is promising in treating these five diseases, so it is necessary to further explore the therapeutic effect and potential mechanism.

Recruiting

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Yiwu, Zhejiang, 322000, China

Location status: Recruiting

Location contact

youhua Lai

CONTACT

[email protected]

+86 15925977413

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Platelet-Rich Plasma (PRP) Injections

Other

Transvaginal or laparoscopic injection for ovarian diseases (Premature ovarian insufficiency and Poor ovarian response). Intrauterine perfusion or sub-endometrium injection for uterine diseases (intrauterine adhesion, thin endometrium, and repeated implantation failure)

Primary outcomes

  1. adverse events or serious adverse events

    Time frame: From enrollment to the end of treatment at 3 months

    Discomfort or clinically significant abnormalities reported by patients after enrollment

Study contacts

Contact information is provided by the study sponsor or research team.

Youhua Lai

CONTACT

[email protected]

+86 15925977413

Sponsors and collaborators

Lead sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 16, 2024
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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