Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06608407
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Platelet Rich Plasma in the Prevention of Adhesion Reformation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Platelet Rich Plasma in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Asherman syndrome which occurs after trauma to the basalis layer of the endometrium It seems that the role of postoperative platelet rich plasmaPRPtherapy 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
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
Detailed Description:
Asherman syndrome which occurs after trauma to the basalis layer of the endometrium It seems that the role of postoperative platelet rich plasmaPRPtherapy 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
Background information Asherman syndrome which occurs after trauma to the basalis layer of the endometrium generally after endometrial curettage may manifest as hypomenorrhea amenorrhea dysmenorrhea infertility or recurrent miscarriage
At present hysteroscopic adhesiolysis is the recommended standard diagnostic method and treatment for IUA Recurrence of uterine cavity adhesion post-operatively is frequently reported especially in severe IUA patients A number of strategies have been proposed to prevent recurrence of adhesion reformation including the use of post-operative PRP However it is still not known if PRP therapy is indeed necessary or effective In a prospective randomized study which evaluated the efficacy of PRP in preventing IUA following hysteroscopic adhesiolysis it was found that PRP did not have any benefit in reducing adhesion formation In another RCT study on women with Asherman syndrome there did not appear to be any difference in the recurrence of IUA and pregnancy rate between those who did or did not receive PRP medication It seems that the role of postoperative PRP therapy in the prevention of recurrence of IUA is still controversial In this prospective randomized controlled study the investigators wish to determine if PRP therapy is of benefit in preventing adhesion reformation after IUA for Asherman syndrome As the effect may be different for subjects with different degrees of IUA the investigators propose to stratify the subjects into those with mild and severe IUAs
Objectives To investigate if PRP therapy can prevent adhesion reformation after adhesiolysis
Participants The participants will be recruited from the hysteroscopy Center of the Fuxing Hospital Beijing China Before the surgery all patients with suspected Asherman syndrome will undergo preoperative evaluations including a detailed history of the menstrual pattern any previous intrauterine surgery reproductive history as well as trans-vaginal ultrasonography The severity and extent of intrauterine adhesions will be scored according to a classification system recommended by the American Fertility Society AFS 1988 version The inclusion criteria include women aged 18-40 years written consent obtained and agreement to have second-look hysteroscopy The exclusion criteria included1 has received estrogen therapy within 3 month of enrolment 2 suffers from leiomyoma endometrial polyps cancer or polycystic ovarian syndrome PCOS 3History of genital tuberculosis
Study Design After the completion of hysteroscopic adhesiolysis recruited patients 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 Power Calculation On the basis of the results of the comparing previous research on using PRP to prevent IUA recurrence the estimated IUA recurrence rates in subjects with moderate to severe IUA AFS score 7-12 are 25 in the PRP group and 54 in the control group Accepting a type 1 error a of 005 and a type 2 error b of 010 the number of subjects in each arm of the randomized controlled trial would be 41 Assuming that the dropout rate is 10 the total number of subject to be recruited would be 46 in each arm the total number of subject to be recruited would be 46 in each arm Procedure Surgical procedure The surgery will be carried out by one of three experienced hysteroscopic surgeons with the use of a 45-mm rigid hysteroscope Olympus with 5 saline perfusion under 100 mm Hg pressure The primary procedure will be performed under general anesthesia in a day surgery unit Ultrasonographic guidance will be routinely used Once the extent and severity of uterine adhesion has been assessed the adhesions will be divided with the use of mono-polar instrument until normal uterine anatomy is achieved
Postoperative treatments All subjects will be treated with oral antibiotic for 5 days Second-look hysteroscopy will be carried out in the early proliferative phase 4 weeks after the initial operation a third-look hysteroscopy will be carried out 8 weeks after the initial operation After assessment of the extent and severity of any reformed adhesion hysteroscopic adhesiolysis will be carried out at the time of the second-look or third-look procedure if adhesion had recurred The surgeon who later performs the second-look and third-look hysteroscopy will be blinded to the randomization
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
Background information Asherman syndrome which occurs after trauma to the basalis layer of the endometrium generally after endometrial curettage may manifest as hypomenorrhea amenorrhea dysmenorrhea infertility or recurrent miscarriage
At present hysteroscopic adhesiolysis is the recommended standard diagnostic method and treatment for IUA Recurrence of uterine cavity adhesion post-operatively is frequently reported especially in severe IUA patients A number of strategies have been proposed to prevent recurrence of adhesion reformation including the use of post-operative PRP However it is still not known if PRP therapy is indeed necessary or effective In a prospective randomized study which evaluated the efficacy of PRP in preventing IUA following hysteroscopic adhesiolysis it was found that PRP did not have any benefit in reducing adhesion formation In another RCT study on women with Asherman syndrome there did not appear to be any difference in the recurrence of IUA and pregnancy rate between those who did or did not receive PRP medication It seems that the role of postoperative PRP therapy in the prevention of recurrence of IUA is still controversial In this prospective randomized controlled study the investigators wish to determine if PRP therapy is of benefit in preventing adhesion reformation after IUA for Asherman syndrome As the effect may be different for subjects with different degrees of IUA the investigators propose to stratify the subjects into those with mild and severe IUAs
Objectives To investigate if PRP therapy can prevent adhesion reformation after adhesiolysis
Participants The participants will be recruited from the hysteroscopy Center of the Fuxing Hospital Beijing China Before the surgery all patients with suspected Asherman syndrome will undergo preoperative evaluations including a detailed history of the menstrual pattern any previous intrauterine surgery reproductive history as well as trans-vaginal ultrasonography The severity and extent of intrauterine adhesions will be scored according to a classification system recommended by the American Fertility Society AFS 1988 version The inclusion criteria include women aged 18-40 years written consent obtained and agreement to have second-look hysteroscopy The exclusion criteria included1 has received estrogen therapy within 3 month of enrolment 2 suffers from leiomyoma endometrial polyps cancer or polycystic ovarian syndrome PCOS 3History of genital tuberculosis
Study Design After the completion of hysteroscopic adhesiolysis recruited patients 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 Power Calculation On the basis of the results of the comparing previous research on using PRP to prevent IUA recurrence the estimated IUA recurrence rates in subjects with moderate to severe IUA AFS score 7-12 are 25 in the PRP group and 54 in the control group Accepting a type 1 error a of 005 and a type 2 error b of 010 the number of subjects in each arm of the randomized controlled trial would be 41 Assuming that the dropout rate is 10 the total number of subject to be recruited would be 46 in each arm the total number of subject to be recruited would be 46 in each arm Procedure Surgical procedure The surgery will be carried out by one of three experienced hysteroscopic surgeons with the use of a 45-mm rigid hysteroscope Olympus with 5 saline perfusion under 100 mm Hg pressure The primary procedure will be performed under general anesthesia in a day surgery unit Ultrasonographic guidance will be routinely used Once the extent and severity of uterine adhesion has been assessed the adhesions will be divided with the use of mono-polar instrument until normal uterine anatomy is achieved
Postoperative treatments All subjects will be treated with oral antibiotic for 5 days Second-look hysteroscopy will be carried out in the early proliferative phase 4 weeks after the initial operation a third-look hysteroscopy will be carried out 8 weeks after the initial operation After assessment of the extent and severity of any reformed adhesion hysteroscopic adhesiolysis will be carried out at the time of the second-look or third-look procedure if adhesion had recurred The surgeon who later performs the second-look and third-look hysteroscopy will be blinded to the randomization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None