Platelet Rich Plasma in the Prevention of Adhesion Reformation

NCT06608407 | Enrolling By Invitation DMC

• 1 other identifier: 2024FXHEC-KSP020
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

Brief Summary

Asherman syndrome, which occurs after trauma to the basalis layer of the endometrium. It seems that the role of postoperative platelet rich plasma（PRP）therapy in the prevention of recurrence of IUA is still controversial. To investigate if PRP therapy can prevent adhesion reformation after adhesiolysis. After the completion of hysteroscopic adhesiolysis, recruited patients will be randomized to one of the two treatment groups by computer-generated numbers: having PRP after hysteroscopic adhesiolysis; and the control group without PRP treatment. A second-look hysteroscopy and ultrasound assessment of the endometrium will be carried out 4 weeks after the surgery, and again at 8 weeks after the surgery.

Conditions

Intrauterine Adhesion; Asherman Syndrome

Keywords

intrauterine adhesion; platelet rich plasma; hysteroscopic adhesiolysis; Fertility outcome

Outcome Measures

Primary Outcomes (2)

• AFS Score at Third-look Hysteroscopy

  The investigators measured the AFS score between the PRP group and Control group through hysteroscopy 8 weeks after operation. American Fertility Society \[(AFS) score in intrauterine adhesion who underwent hysteroscopic adhesiolysis.The higher the score, the heavier the degree of adhesion. The AFS (American Fertility Society) scoring system for endometrial assessment is as follows: Extent of involvement: 1 point(\<1/3 of the uterine cavity); 2 points(1/3 to 2/3 of the uterine cavity); 4 points(2/3 of the uterine cavity). Type of adhesion:1 point(Filmy); 2 points(Filmy and dense); 4 points(Dense) . Menstrual pattern:1 point(Normal menses); 2 points(Menstrual reduction); 4 points(Amenorrhea) . Points are summed to give a total score ranging from 1 to 12, which is used to classify the degree of endometrial injury or disease:Mild (Grade I): 1 to 4 points;Moderate (Grade II): 5 to 8 points;Severe (Grade III): 9 to 12 points.

  8 weeks after operation

• Endometrial thickness under ovulation ultrasound

  Ultrasound measurement of endometrial thickness during ovulation period three months after adhesion release surgery

  3 months

Study Arms (2)

PRP Group

EXPERIMENTAL

After the completion of hysteroscopic adhesiolysis, recruited participants will be randomized to one of the two treatment groups by computer-generated numbers: Immediately administer uterine perfusion with PRP after surgery, and administered PRP perfusion during hysteroscopy at 4 and 8 weeks after hysteroscopic adhesiolysis, A second-look hysteroscopy and ultrasound assessment of the endometrium will be carried out 4 weeks after the surgery, and again at 8 weeks after the surgery.

Biological: PRP group

Control group

NO INTERVENTION

Control group without PRP treatment.

Interventions

PRP group BIOLOGICAL

After the completion of hysteroscopic adhesiolysis, recruited participants will be randomized to one of the two treatment groups by computer-generated numbers: Immediately administer uterine perfusion with PRP after surgery, and administered PRP perfusion during hysteroscopy at 4 and 8 weeks after hysteroscopic adhesiolysis, A second-look hysteroscopy and ultrasound assessment of the endometrium will be carried out 4 weeks after the surgery, and again at 8 weeks after the surgery. Control group without PRP treatment.

PRP Group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis of Asherman's syndrome. AFS score \>7.

You may not qualify if:

• Leiomyoma;
• Endometrial polyps;
• Ppolycystic ovarian syndrome (PCOS).

Sponsors & Collaborators

• Fu Xing Hospital, Capital Medical University: lead

Study Sites (2)

Fu Xing Hospital, Capital Medical University

Beijing, Beijing Municipality, 100073, China

Location

Fuxing hospital

Beijing, Beijing Municipality, 100073, China

Location

MeSH Terms

Conditions

Gynatresia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: October 10, 2023
• Primary Completion: April 11, 2025
• Study Completion: June 1, 2025
• Last Updated: March 11, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)