Ovarian TorsionOTAMHNCT03852615
Ovarian Reserve After Ovarian Torsion
A study testing Pre operation Blood sample for AMH and 3 month post operation blood sample for AMH in people with Ovarian Torsion, run by Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Torsion
- What is being tested?
- Pre operation Blood sample for AMH and 3 month post operation blood sample for AMH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2019to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Suspected ovarian torsion
- Laparoscopy operation - explorative / de-torsion of ovary
Who cannot join
- Severe endometriosis
- Known premature ovarian failure
- Past ovarian operations other than de- torsion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Ovarian Torsion and Surgical De-torsion on Ovarian Reserve
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.
Read the 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.
- Conditions
- Ovarian Torsion
- Being tested
- Pre operation Blood sample for AMH, 3 month post operation blood sample for AMH
- Keywords
- Ovarian Torsion, Laparoscopy, Anti Mullarian Hormone (AMH)
- Medical subject headings
- Ovarian Torsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Pre operation Blood sample for AMH; Diagnostic 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 Receives: Diagnostic Test: Pre operation Blood sample for AMH; Diagnostic Test: 3 month post operation blood sample for AMH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti Mullarian Hormone (AMH) change
The change in Anti Mullarian Hormone (AMH) levels before and three month after laparoscopy
Measured: From date of recruitment before laparoscopy until three month after laparoscopy
Secondary outcomes (3)
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)
Measured: 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
Measured: 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
Measured: During laparoscopic operation, and through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start1 Mar 2019
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Ovarian TorsionStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Aya Mohr-Sasson, Sheba Medical Center
- Investigators
- Aya Mohr Sasson, Principal investigator, Sheba Medical Center, Tel-Hashomer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852615
- Sponsor's protocol ID
- 5646-18-SMC
- Acronym
- OTAMH
- Status last verified
- Apr 2025
- First submitted
- 12 Feb 2019
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26212687Robertson 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.
PubMed 27988260Grunau 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.
PubMed 29681508Fujishita 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.
PubMed 25363700Dasgupta 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.
PubMed 29153467Kaya 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.
PubMed 24996496Parlakgumus 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.
PubMed 24507756Yasa 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.
PubMed 27928855
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Ovarian Torsion and Surgical De-torsion on Ovarian Reserve
- ClinicalTrials.gov ID
- NCT03852615
- Acronym / sponsor ID
- OTAMH / 5646-18-SMC
- Conditions
- Ovarian Torsion
- Keywords
- Ovarian Torsion, Laparoscopy, Anti Mullarian Hormone (AMH)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 25 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Ovarian torsion | Experimental | Diagnostic Test: Pre operation Blood sample for AMH, Diagnostic Test: 3 month post operation blood sample for AMHWomen admitted to the gynecological emergency room with high clinical suspicious of ovarian torsion, that went through laparoscopic ovarian de-torsion surgery |
| No ovarian torsion | Other | Diagnostic Test: Pre operation Blood sample for AMH, Diagnostic Test: 3 month post operation blood sample for AMHControl 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 |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Suspected ovarian torsion
- Laparoscopy operation - explorative / de-torsion of ovary
Key exclusion criteria (3 listed)
- Severe endometriosis
- Known premature ovarian failure
- Past ovarian operations other than de- torsion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre operation Blood sample for AMHBlood sample for Anti Mullarian Hormone (AMH) analysis will be taken during preparation for surgery, while inserting vein line and taking the customary blood samples. | Diagnostic test | No ovarian torsion, Ovarian torsion |
| 3 month post operation blood sample for AMHAdditional blood sampling that will include a single tube containing 3 cc of blood for analysis of AMH will be taken three month from operation. | Diagnostic test | No ovarian torsion, Ovarian torsion |
Primary outcome
Anti Mullarian Hormone (AMH) change
Time frame: From date of recruitment before laparoscopy until three month after laparoscopy
The change in Anti Mullarian Hormone (AMH) levels before and three month after laparoscopy
3 secondary outcomes
Ovarian change in color after de-torsion during laparoscopy
Time frame: During laparoscopic operation, and through study completion, an average of 1 year
Time to de-torsion
Time frame: Estimated time from admission to the emergency room to de-torsion during laparoscopy in minutes
Ovarian size after de-torsion during laparoscopy
Time frame: During laparoscopic operation, and through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Results publication: PubMed 26212687Asfour 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.
- Results publication: PubMed 27988260Robertson 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.
- Results publication: PubMed 29681508Grunau 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.
- Results publication: PubMed 25363700Fujishita 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.
- Results publication: PubMed 29153467Dasgupta 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.
- Results publication: PubMed 24996496Kaya 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.
- Results publication: PubMed 24507756Parlakgumus 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.
- Results publication: PubMed 27928855Yasa 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.
- Individual participant dataSharing planned: Undecided
Related trials for Ovarian Torsion
RecruitingObservational study
Pediatric Ovarian Tissue Banking - Operative Specimens From Females 0-18 Years of Age
Benign Cysts Ovarian, Cystectomy
RecruitingPhase 3
Contribution of Contrast Enhanced Ultrasound for Diagnosis of Adnexal Torsion
Adnexal Torsion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aya Mohr Sasson principal investigator
Sheba Medical Center, Tel-Hashomer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre operation Blood sample for AMH and 3 month post operation blood sample for AMH in people with Ovarian Torsion, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti Mullarian Hormone (AMH) change (time frame: From date of recruitment before laparoscopy until three month after laparoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03852615, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.