NCT03852615

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 25, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

4 years

First QC Date

February 12, 2019

Last Update Submit

April 7, 2025

Conditions

Ovarian Torsion

Keywords

Ovarian TorsionLaparoscopyAnti Mullarian Hormone (AMH)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Ovarian change in color after de-torsion during laparoscopy

    During laparoscopic operation, and through study completion, an average of 1 year

  • Time to de-torsion

    Estimated time from admission to the emergency room to de-torsion during laparoscopy in minutes

  • Ovarian size after de-torsion during laparoscopy

    During laparoscopic operation, and through study completion, an average of 1 year

Study Arms (2)

Ovarian torsion

EXPERIMENTAL

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 AMHDiagnostic Test: 3 month post operation blood sample for AMH

No ovarian torsion

OTHER

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 AMHDiagnostic Test: 3 month post operation blood sample for AMH

Interventions

Pre operation Blood sample for AMHDIAGNOSTIC_TEST

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.

No ovarian torsionOvarian torsion
3 month post operation blood sample for AMHDIAGNOSTIC_TEST

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.

No ovarian torsionOvarian torsion

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Suspected ovarian torsion
  • Laparoscopy operation - explorative / de-torsion of ovary

You may not qualify if:

  • Severe endometriosis
  • Known premature ovarian failure
  • Past ovarian operations other than de- torsion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aya Mohr Sasson

Ramat Gan, Please Select, 52621, Israel

Location

Related Publications (8)

  • 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.

    PMID: 26212687RESULT

  • 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.

    PMID: 27988260RESULT

  • 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.

    PMID: 29681508RESULT

  • 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.

    PMID: 25363700RESULT

  • 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.

    PMID: 29153467RESULT

  • 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.

    PMID: 24996496RESULT

  • 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.

    PMID: 24507756RESULT

  • 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.

    PMID: 27928855RESULT

MeSH Terms

Conditions

Ovarian Torsion

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesTorsion AbnormalityPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Aya Mohr Sasson

    Sheba Medical Center, Tel-Hashomer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 12, 2019

First Posted

February 25, 2019

Study Start

March 1, 2019

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

April 9, 2025

Record last verified: 2025-04

Locations

IL(1)