Clinical trial NCT03852615: Ovarian Reserve After Ovarian Torsion
Official title: The Influence of Ovarian Torsion and Surgical De-torsion on Ovarian Reserve
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Torsion
Keywords: Ovarian Torsion
Laparoscopy
Anti Mullarian Hormone (AMH)
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-02-25
Enrollment: 81
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Anti Mullarian Hormone (AMH) change
timeFrame: From date of recruitment before laparoscopy until three month after laparoscopy
Secondary outcomes:
measure: Ovarian change in color after de-torsion during laparoscopy
timeFrame: During laparoscopic operation, and through study completion, an average of 1 year
measure: Time to de-torsion
timeFrame: Estimated time from admission to the emergency room to de-torsion during laparoscopy in minutes
measure: Ovarian size after de-torsion during laparoscopy
timeFrame: During laparoscopic operation, and through study completion, an average of 1 year
Other outcomes:
Locations:
city: Ramat -Gan
country: Israel
facility: Aya Mohr Sasson
state: Please Select
Study officials:
affiliation: Sheba Medical Center, Tel-Hashomer
name: Aya Mohr Sasson
role: PRINCIPAL_INVESTIGATOR
References:
citation: Asfour V, Varma R, Menon P. Clinical risk factors for ovarian torsion. J Obstet Gynaecol. 2015;35(7):721-5. doi: 10.3109/01443615.2015.1004524. Epub 2015 Jul 27.
citation: Robertson JJ, Long B, Koyfman A. Myths in the Evaluation and Management of Ovarian Torsion. J Emerg Med. 2017 Apr;52(4):449-456. doi: 10.1016/j.jemermed.2016.11.012. Epub 2016 Dec 14.
citation: Grunau GL, Harris A, Buckley J, Todd NJ. Diagnosis of Ovarian Torsion: Is It Time to Forget About Doppler? J Obstet Gynaecol Can. 2018 Jul;40(7):871-875. doi: 10.1016/j.jogc.2017.09.013. Epub 2018 Apr 19.
citation: Fujishita A, Araki H, Yoshida S, Hamaguchi D, Nakayama D, Tsuda N, Khan KN. Outcome of conservative laparoscopic surgery for adnexal torsion through one-stage or two-stage operation. J Obstet Gynaecol Res. 2015 Mar;41(3):411-7. doi: 10.1111/jog.12534. Epub 2014 Nov 3.
citation: Dasgupta R, Renaud E, Goldin AB, Baird R, Cameron DB, Arnold MA, Diefenbach KA, Gosain A, Grabowski J, Guner YS, Jancelewicz T, Kawaguchi A, Lal DR, Oyetunji TA, Ricca RL, Shelton J, Somme S, Williams RF, Downard CD. Ovarian torsion in pediatric and adolescent patients: A systematic review. J Pediatr Surg. 2018 Jul;53(7):1387-1391. doi: 10.1016/j.jpedsurg.2017.10.053. Epub 2017 Nov 16.
citation: Kaya C, Turgut H, Cengiz H, Turan A, Ekin M, Yasar L. Effect of detorsion alone and in combination with enoxaparin therapy on ovarian reserve and serum antimullerian hormone levels in a rat ovarian torsion model. Fertil Steril. 2014 Sep;102(3):878-884.e1. doi: 10.1016/j.fertnstert.2014.06.007. Epub 2014 Jul 1.
citation: Parlakgumus HA, Aka Bolat F, Bulgan Kilicdag E, Simsek E, Parlakgumus A. Atorvastatin for ovarian torsion: effects on follicle counts, AMH, and VEGF expression. Eur J Obstet Gynecol Reprod Biol. 2014 Apr;175:186-90. doi: 10.1016/j.ejogrb.2014.01.017. Epub 2014 Jan 20.
citation: Yasa C, Dural O, Bastu E, Zorlu M, Demir O, Ugurlucan FG. Impact of laparoscopic ovarian detorsion on ovarian reserve. J Obstet Gynaecol Res. 2017 Feb;43(2):298-302. doi: 10.1111/jog.13195. Epub 2016 Dec 8.