Status:

RECRUITING

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

Lead Sponsor:

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Conditions:

Premature Ovarian Insufficiency

Intrauterine Adhesion

Eligibility:

FEMALE

18-50 years

Phase:

NA

Brief Summary

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 re...

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.

Key Trial Info

Start Date :

October 17 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 15 2027

Estimated Enrollment :

300 Patients enrolled

Trial Details

Trial ID

NCT06645379

Start Date

October 17 2024

End Date

September 15 2027

Last Update

February 18 2025

Active Locations (1)

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The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Yiwu, Zhejiang, China, 322000