Ignite Creation Date:
2024-05-06 @ 12:48 PM
Last Modification Date:
2024-10-26 @ 1:04 PM
Study NCT ID:
NCT03852615
Status:
RECRUITING
Last Update Posted:
2023-06-22
First Post:
2019-02-12
Brief Title:
Ovarian Reserve After Ovarian Torsion
Sponsor:
Sheba Medical Center
Organization:
Sheba Medical Center
Study Overview
Official Title:
The Influence of Ovarian Torsion and Surgical De-torsion on Ovarian Reserve
Status:
RECRUITING
Status Verified Date:
2023-06
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:
OTAMH
Brief Summary:
Ovarian torsion is a relatively common gynecological emergency usually presenting as acute lower abdominal pain Due to patients presentation diversity the diagnosis is clinical and requires integration of different factors and the exclusion of other non-gynecological pathologies Surgery is the definitive treatment and may still be effective after several hours of symptoms Delay in treatment can impact fertility adversely The aim of this study is to evaluate the change in anti mullarian hormone before and after laparoscopic de-torsion of the ovary in our medical center compared to controls
Detailed Description:
Ovarian torsion is a relatively common gynecological emergency usually presenting as acute lower abdominal pain The underlying pathophysiology involves torsion of the ovarian tissue on its pedicle leading to reduced venous return stromal edema internal hemorrhage and infarction with the subsequent sequelae
The diagnosis of ovarian torsion is not an easy diagnosis to make and it is commonly missed Signs and symptoms often mimic other disorders such as appendicitis pyelonephritis and nephrolithiasis Abnormal arterial blood flow on ultrasound does not rule out ovarian torsion and not every patient will have a mass on imaging or a palpable mass on examination Patients may have symptoms for several hours or days and thus may present even with a longer duration of symptoms Due to patients presentation diversity the diagnosis is clinical and requires integration of different factors and the exclusion of other non-gynecological pathologies
Surgery is the definitive treatment and may still be effective after several hours of symptoms Delay in treatment can impact fertility adversely Conservative laparoscopic surgery for de-torsion is considered a safe procedure to preserve ovarian function in women with adnexal torsion and is mostly salvaged ovaries will maintain viability after de-torsion
Although the main reason for emergent operation is to rescue ovarian tissue in order to preserve future fertility studies are scarce and mostly performed on animals models Yasa et al studied the ovarian reserve evaluated by antral follicle count and AMH levels in 11 patients with ovarian torsion that underwent laparoscopic de-torsion rand found no significant change in serum AMH level at 1 and 3 months after laparoscopic de-torsion compared with the preoperative levels however sample size was small The aim of this study is to evaluate the change in anti mullarian hormone before and after laparoscopic de-torsion of the ovary in our medical center compared to controls
Material and methods This is a prospective case control study including all women admitted to the gynecological emergency room with high clinical suspicious of ovarian torsion that are planned to go through laparoscopic surgery Study group will include women that will be diagnosed with ovarian torsion during operation that will be compared to controls- women that ovarian torsion was not demonstrated
All women will sign informed consent before admitted to operation room after given explanation from one of the study researchers During preparation to surgery while inserting vein line and taking the customary blood samples additional tube that will include 3 cc of blood will be taken for Anti Mullarian Hormone AMH analysis in the endocrinology laboratories All women will be coordinated by the study coordinator for a second visit in the gynecological ward three month from operation for additional blood sampling that will include a single tube containing 3 cc of blood for analysis of AMH
The diagnosis of ovarian torsion is not an easy diagnosis to make and it is commonly missed Signs and symptoms often mimic other disorders such as appendicitis pyelonephritis and nephrolithiasis Abnormal arterial blood flow on ultrasound does not rule out ovarian torsion and not every patient will have a mass on imaging or a palpable mass on examination Patients may have symptoms for several hours or days and thus may present even with a longer duration of symptoms Due to patients presentation diversity the diagnosis is clinical and requires integration of different factors and the exclusion of other non-gynecological pathologies
Surgery is the definitive treatment and may still be effective after several hours of symptoms Delay in treatment can impact fertility adversely Conservative laparoscopic surgery for de-torsion is considered a safe procedure to preserve ovarian function in women with adnexal torsion and is mostly salvaged ovaries will maintain viability after de-torsion
Although the main reason for emergent operation is to rescue ovarian tissue in order to preserve future fertility studies are scarce and mostly performed on animals models Yasa et al studied the ovarian reserve evaluated by antral follicle count and AMH levels in 11 patients with ovarian torsion that underwent laparoscopic de-torsion rand found no significant change in serum AMH level at 1 and 3 months after laparoscopic de-torsion compared with the preoperative levels however sample size was small The aim of this study is to evaluate the change in anti mullarian hormone before and after laparoscopic de-torsion of the ovary in our medical center compared to controls
Material and methods This is a prospective case control study including all women admitted to the gynecological emergency room with high clinical suspicious of ovarian torsion that are planned to go through laparoscopic surgery Study group will include women that will be diagnosed with ovarian torsion during operation that will be compared to controls- women that ovarian torsion was not demonstrated
All women will sign informed consent before admitted to operation room after given explanation from one of the study researchers During preparation to surgery while inserting vein line and taking the customary blood samples additional tube that will include 3 cc of blood will be taken for Anti Mullarian Hormone AMH analysis in the endocrinology laboratories All women will be coordinated by the study coordinator for a second visit in the gynecological ward three month from operation for additional blood sampling that will include a single tube containing 3 cc of blood for analysis of AMH
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