Effect of platelet-rich plasma gel on intrauterine adhesions

ISRCTN ISRCTN59253147
DOI https://doi.org/10.1186/ISRCTN59253147
Submission date
24/06/2020
Registration date
02/07/2020
Last edited
02/09/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Background and study aims
Intrauterine adhesions (IUAs) form when scar tissue builds up between the inner walls of the uterus causing the walls to bind together. The incidence rate of IUA is high after multiple artificial abortion and curettage. It severely results in amenorrhea (stopped periods), infertility and recurrent pregnancy loss. Although a surgical procedure called transcervical resection of adhesion (TCRA) can improve the uterine morphology, the postoperative re-adhesion rate reaches 62.5%. Platelet-rich plasma (PRP) contains a large amount of growth factors. Once activated by thrombin and calcium chloride, these growth factors will play roles in promoting tissue growth. Autologous platelet-rich gel (APG) is a gelatinous substance formed by mixing thrombin and calcium with PRP, which is obtained from peripheral venous blood of the patient. The aim of this study is to research the application of APG in preventing recurrence of IUA after TCRA.

Who can participate?
Women between 18 and 40 years old with moderate or severe degree intrauterine adhesion and no previous history of hysteroscopic adhesiolysis (a procedure used to treat adhesions)

What does the study involve?
The same hysteroscopic adhesion resection will be performed on all patients, and then they will be randomly allocated to two groups:
APG group: APG is injected into the uterine cavity after TCRA and an intrauterine device (IUD) is fitted
Control group: medical chitosan is injected into the uterine cavity and an IUD is fitted
All the patients undergo TCRA between 3 to 7 days after menstruation. In all cases hormone therapy is started from the day of the operation, consisting of Femoston (estradiol 2 mg/dydrogesterone 10 mg) at a dose of two tablets per day for 28 days. Following the withdrawal bleed, the hormone therapy was repeated for another cycle. A second look hysteroscopy is carried out 2 months after the initial operation, assessing the adhesion score. Both IUDs will be removed at the second look. Should recurrence of intrauterine adhesions be confirmed during the second look hysteroscopy, a repeat adhesiolysis procedure is performed.

What are the possible benefits and risks of participating?
The benefit of participating is to improve the degree of intrauterine adhesions. The risk of participating is the infection risk. Other side effects are the complications related to the surgery.

Where is the study run from?
Shengjing Hospital of China Medical University (China)

When is the study starting and how long is it expected to run for?
January 2019 to May 2021

Who is funding the study?
Shengjing Hospital of China Medical University (China)

Who is the main contact?
Prof. Guangwei Wang
283490189@qq.com

Contact information

Prof Guangwei Wang
Scientific

Shengjing Hospital of China Medical University
No. 36, Sanhao Street
Heping District
Shenyang
110004
China

Phone +86 (0)24 18940258389
Email 283490189@qq.com
Ms Yutong Ge
Public

Shenyang Engineering Technology R&D Center of Cell Therapy Co., Ltd
A10,400-8 wisdom Second Street
Hunnan District
Shenyang
110004
China

Phone +86 (0)24 15142525031
Email 108213281@qq.com

Study information

Study designSingle-center randomized study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleA comparison of autologous platelet-rich plasma gel and medical chitosan in the prevention of adhesion after hysteroscopic adhesiolysis
Study acronymPRPIUA
Study hypothesisThe adhesion recurrence rate is lower when the platelet-rich plasma (PRP) is injected into the uterine cavity after TRCA compared to medical chitosan, whereas the pregnancy rates are similar in two groups. The hypothesis of the study is that women with moderate to severe intrauterine adhesion may benefit from exposure to growth factors known to be present in PRP.
Ethics approval(s)Approved 20/01/2019, Institutional Review Board of the Shengjing Hospital of China Medical University (No. 36 Sanhao Street, Heping District, Shenyang, China, 110004; +86 (0)24 96615 10027; llwyh@sj-hospital.org), ref: 2019PS014J
ConditionIntrauterine adhesion
InterventionIn all cases hysteroscopy is carried out under general anaesthesia which confirmed the presence of intrauterine adhesions. Hysteroscopy examination is carried out by two reproductive surgeons and the case is recruited if the AFS score is equal or more than 5. A 4.5 mm hysteroscope (Storz, Germany) is used in each case. The same hysteroscopic adhesion resection will be performed on all patients, and then they will be randomly allocated by computer-generated numbers to two groups. The procedures of TCRA are carried out under ultrasound or laparoscopic guidance when necessary.

APG group: APG 5 ml is injected into the uterine cavity after TRCA and an IUD is fitted
Control group: medical chitosan 5 ml is injected into the uterine cavity and an IUD is fitted

All the patients undergo TRCA between 3 to 7 days after menstruation. In all cases hormone therapy is commenced from the day of operation, consisting of Femoston (estradiol 2 mg/dydrogesterone 10 mg) at a dose of two tablets per day for 28 days. Following the withdrawal bleed, the hormone therapy is repeated for another cycle.

A second look hysteroscopy is carried out in the early proliferative phase, 2 months after the initial operation, assessing the adhesion score by AFS criteria. Both IUDs will be removed at the second look. Should recurrence of intrauterine adhesions be confirmed during the second look hysteroscopy, a repeat adhesiolysis procedure would be performed.
Intervention typeProcedure/Surgery
Primary outcome measureThe severity and extent of intrauterine adhesions scored according to a classification system recommended by the American Fertility Society (AFS) (1988 version), measured 2 months after surgery
Secondary outcome measuresPregnancy rates measured using ultrasound after the operation until 1 year after the termination of the clinical trial
Overall study start date03/01/2019
Overall study end date31/05/2021

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants80
Participant inclusion criteria1. Moderate to severe intrauterine adhesion (AFS score ≥5)
2. No previous history of hysteroscopic adhesiolysis
3. Written consent obtained
4. Agreement to have second-look hysteroscopy
5. All the participants should be ≥18 years and younger than 40 years old
Participant exclusion criteria1. Pregnancy or breastfeeding women
2. Minimal adhesion(AFS<5)
3. Previous history of hysteroscopic adhesiolysis
4. Highly allergic constitution or a history of severe allergic to thrombin
5. Systemic infection or severe local infection
6. Amenorrhea due to ovarian hypofunction or other causes
7. Severe cardiopulmonary disease, liver and kidney dysfunction and other severe underlying disease
8. Poor compliance (cannot finish the trial) or the investigator believes that the patient is not appropriate for treatment
Recruitment start date01/05/2020
Recruitment end date05/02/2021

Locations

Countries of recruitment

  • China

Study participating centre

Shengjing Hospital of China Medical University
No. 36, Sanhao Street
Heping District
Shenyang
110004
China

Sponsor information

Sheng Jing Hospital
Hospital/treatment centre

No. 36, Sanhao Street
Heping District
Shenyang
110004
China

Phone +86 (0)24 18940258389
Email 283490189@qq.com
Website http://www.sj-hospital.org/
ROR logo "ROR" https://ror.org/0202bj006
Shenyang Engineering Technology R&D Center of Cell Therapy Co., Ltd
Industry

A10,400-8 wisdom Second Street
Hunnan District
Shenyang
110004
China

Phone +86 (0)15142525031
Email 108213281@qq.com

Funders

Funder type

Hospital/treatment centre

Sheng Jing Hospital

No information available

Results and Publications

Intention to publish date31/12/2021
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal. The protocol has not been published. Additional documents would be available if the result is published.
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Guangwei Wang (283490189@qq.com).

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 08/08/2023 02/09/2024 Yes No

Editorial Notes

02/09/2024: Publication reference added.
19/02/2021: The recruitment end date has been changed from 31/01/2021 to 05/02/2021.
01/07/2020: Trial's existence confirmed by Institutional Review Board of the Shengjing Hospital of China Medical University.