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

NCT06645379 | Recruiting

• 1 other identifier: KY-2024-176
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• adverse events or serious adverse events

  Discomfort or clinically significant abnormalities reported by patients after enrollment

  From enrollment to the end of treatment at 3 months

Study Arms (1)

reproductive disease

EXPERIMENTAL

Platelet-rich Plasma injection

Other: Platelet-Rich Plasma (PRP) Injections

Interventions

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)

reproductive disease

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Yiwu, Zhejiang, 322000, China

RECRUITING

MeSH Terms

Conditions

Primary Ovarian Insufficiency; Gynatresia

Interventions

Injections

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Youhua Lai

CONTACT

+86 15925977413; tj_lyh1@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 16, 2024
• Study Start: October 17, 2024
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): September 15, 2027
• Last Updated: February 18, 2025

Record last verified: 2025-02

Locations

CN (1)