Ovarian Reserve After Ovarian Torsion

Study Overview
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Brief Summary
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Ovarian torsion is a relatively common gynecological emergency, usually presenting as acute lower abdominal pain. Due to patient's 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
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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 patient's 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.

Official Title
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The Influence of Ovarian Torsion and Surgical De-torsion on Ovarian Reserve

Conditions
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Ovarian Torsion

Intervention / Treatment
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* Diagnostic Test: Pre operation Blood sample for AMH
* Diagnostic Test: 3 month post operation blood sample for AMH


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suspected ovarian torsion Laparoscopy operation - explorative / de-torsion of ovary Exclusion Criteria: Severe endometriosis Known premature ovarian failure Past ovarian operations other than de- torsion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ovarian torsion<br>Women admitted to the gynecological emergency room with high clinical suspicious of ovarian torsion, that went through laparoscopic ovarian de-torsion surgery | Diagnostic Test: Pre operation Blood sample for AMH<br>* Blood sample for Anti Mullarian Hormone (AMH) analysis will be taken during preparation for surgery, while inserting vein line and taking the customary blood samples.<br>Diagnostic Test: 3 month post operation blood sample for AMH<br>* Additional blood sampling that will include a single tube containing 3 cc of blood for analysis of AMH will be taken three month from operation.<br>|
| Other: No ovarian torsion<br>Control group - Women admitted to the gynecological emergency room with high clinical suspicious of ovarian torsion and went through laparoscopic surgery, however no ovarian torsion has been demonstrated | Diagnostic Test: Pre operation Blood sample for AMH<br>* Blood sample for Anti Mullarian Hormone (AMH) analysis will be taken during preparation for surgery, while inserting vein line and taking the customary blood samples.<br>Diagnostic Test: 3 month post operation blood sample for AMH<br>* Additional blood sampling that will include a single tube containing 3 cc of blood for analysis of AMH will be taken three month from operation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti Mullarian Hormone (AMH) change | The change in Anti Mullarian Hormone (AMH) levels before and three month after laparoscopy | From date of recruitment before laparoscopy until three month after laparoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovarian change in color after de-torsion during laparoscopy | Ovarian color before and after de-torsion , as described by the operator (black- necrotic , blue- highly congested, red- hyperemic , pink-normal) | During laparoscopic operation, and through study completion, an average of 1 year | 
| Time to de-torsion | Time from admission to the emergency room to de-torsion in minutes | Estimated time from admission to the emergency room to de-torsion during laparoscopy in minutes | 
| Ovarian size after de-torsion during laparoscopy | Estimated size of the ovary in centimeters | During laparoscopic operation, and through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian Torsion, Laparoscopy, Anti Mullarian Hormone (AMH)