Ignite Creation Date:
2024-05-06 @ 9:54 AM
Last Modification Date:
2024-10-26 @ 12:21 PM
Study NCT ID:
NCT03109964
Status:
COMPLETED
Last Update Posted:
2022-10-26
First Post:
2017-03-29
Brief Title:
The Affect of Hemostasis Technique During Laparoscopic Ovarian Cystectomy on Future Fertility
Sponsor:
Rambam Health Care Campus
Organization:
Rambam Health Care Campus
Study Overview
Official Title:
The Affect of Hemostasis With Bipolar Coagulation Versus SURGIFLO Placement on Ovarian Reserve and Future Fertility
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients undergoing elective laparoscopic ovarian cystectomy will be recruited and randomly divided into 2 groups according to intervention technique-half will be allocated to the bipolar coagulation group and half to the SURGIFLO group
Patients will be assessed both pre-operatively and 6 months post-operatively by blood tests including follicle stimulating hormone FSH lutenizing hormone LH Estrogen E2 Progesterone and anti-mullerian hormone AMH levels and sonographic evaluation of ovarian volume and antral follicle count
Patients will be assessed both pre-operatively and 6 months post-operatively by blood tests including follicle stimulating hormone FSH lutenizing hormone LH Estrogen E2 Progesterone and anti-mullerian hormone AMH levels and sonographic evaluation of ovarian volume and antral follicle count
Detailed Description:
Patients undergoing elective laparoscopic ovarian cystectomy will be recruited after signing an informed consent and randomly divided into 2 groups according to intervention technique-half will be allocated to the bipolar coagulation group and half to the SURGIFLO group
Patients will be assessed both pre-operatively and 6 months post-operatively by blood tests including FSH LH E2 Progesterone and AMH levels and sonographic evaluation of ovarian volume and antral follicle count
Antral follicle count will be performed on the cyst post-surgery using light microscopy The difference in hormone levels especially AMH reflects the damage done during surgery to the ovarian reserve Sonographic signs including a decrease in ovarian volume and antral follicle count also reflect the damage done during surgery to the ovarian reserve
Patients will be assessed both pre-operatively and 6 months post-operatively by blood tests including FSH LH E2 Progesterone and AMH levels and sonographic evaluation of ovarian volume and antral follicle count
Antral follicle count will be performed on the cyst post-surgery using light microscopy The difference in hormone levels especially AMH reflects the damage done during surgery to the ovarian reserve Sonographic signs including a decrease in ovarian volume and antral follicle count also reflect the damage done during surgery to the ovarian reserve
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None