Ovarian InsufficiencyNCT06903650
The Effect of Salpingectomy Operation on Ovarian Reserve
An observational study of Ovarian Insufficiency, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the effect of salpingectomy operation on ovarian reserve. Ovarian reserve was evaluated by measuring anti-mullerian hormone levels from serum samples taken from the patients before the operation and 6 weeks after the operation. Read more about this study
- Who is it for?
- Ages 37 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Insufficiency
- What is being tested?
- bilateral salpingectomy, ovarian arter doppler ultrasonography
- Type of treatment
- Surgery or procedure
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Oct 2020to 5 Jun 2021
- Phase
- Observational
- 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 37 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Serum samples will be separated from routine blood samples taken from patients who apply to the outpatient clinic and will undergo salpingectomy within the indication, during perioperative preparation and at the 6th week postoperatively, after patient consent is obtained. This serum sample will be taken into an Eppendorf tube and kept at -40˚C for later AMH levels to be studied. Ovarian artery pulsatility index values measured during the patient's perioperative and postoperative routine ultrasonographic examination and weeks 6 postoperative control will be recorded.
Who may be able to join
- Women between the ages of 37-45 with continuing menstrual cycles (37 and 45 included)
- Patients who will undergo uterine surgery for benign reasons or who will undergo salpingectomy only due to hydrosalpinx, ectopic pregnancy, tubo-ovarian abscess
- Patients who have not had ovarian surgery before
- Those without menopause and premature ovarian failure
- Patients who accept the study
Who cannot join
- Age younger than 37 or older than 45
- Those who want to withdraw from the study
- Those who do not come for follow-up examination
- Use of drugs that affect ovarian reserve
- Any surgical procedure performed on the ovaries during the operation
- No menstrual bleeding in the last year
- Patients who received radiotherapy and hormonal therapy within 3 months before surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dokuz Eylul University School of Medicine
Izmir, 35000
About this study
Official title: Evaluation of the Effect of Salpingectomy Operation on Ovarian Reserve With Anti-Mullerian Hormone and Ovarian Doppler Ultrasonography
This study aimed to evaluate the effect of salpingectomy operation on ovarian reserve. Ovarian reserve was evaluated by measuring anti-mullerian hormone levels from serum samples taken from the patients before the operation and 6 weeks after the operation. Ovarian doppler flow were evaluated by measuring the ovarian artery pulsatility index with transvaginal ultrasonography preoperatively, postoperative days 2 and postoperative weeks 6 . In our study, it was determined that ovarian functions may be negatively affected in the acute period after salpingectomy operation.
- Conditions
- Ovarian Insufficiency
- Being tested
- bilateral salpingectomy, ovarian arter doppler ultrasonography
- Keywords
- Salpingectomy, Ovarian Reserve, Anti-Mullerian Hormone, Doppler Ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilateral salpingectomy, ovarian arter doppler ultrasonographyProcedure or surgery
The effect of salpingectomy operation on ovarian reserve
| Study group | Role | What they receive |
|---|---|---|
| perioperative ovarian arter pulsatility index(PI)(right and left), perioperative AMH levels | Not described Receives: Procedure: bilateral salpingectomy, ovarian arter doppler ultrasonography | |
| postoperative days 2 ovarian arter pulsatility index (PI) (right and left) | Not described Receives: Procedure: bilateral salpingectomy, ovarian arter doppler ultrasonography | |
| postop. weeks 6 ovarian arter pulsatility index(PI)(right and left), postop. weeks 6 AMH levels | Not described Receives: Procedure: bilateral salpingectomy, ovarian arter doppler ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
right ovarian arter pı
rate of 0,87/ 0,84/ 0,76
Measured: perioperative, postoperative days 2 , postoperative weeks 6
left ovarian arter pı
rate of 0,89/ 0,79/ 0.80
Measured: perioperative, postoperative days 2, postoperative weeks 6
AMH levels
Concentration of 1 ng/mL / 0,79 ng/mL
Measured: perioperative-postoperative weeks 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2025
- Study start27 Oct 2020
- Primary completion3 Mar 2021
- Study completion5 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian InsufficiencyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derya Öztürk, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903650
- Sponsor's protocol ID
- SOORAMHODU
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Salpingectomy Operation on Ovarian Reserve With Anti-Mullerian Hormone and Ovarian Doppler Ultrasonography
- ClinicalTrials.gov ID
- NCT06903650
- Acronym / sponsor ID
- SOORAMHODU
- Conditions
- Ovarian Insufficiency
- Keywords
- Salpingectomy, Ovarian Reserve, Anti-Mullerian Hormone, Doppler Ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 3 Mar 2021 (actual)
- Study completion
- 5 Jun 2021 (actual)
- First posted
- 31 Mar 2025 (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.
This study aimed to evaluate the effect of salpingectomy operation on ovarian reserve. Ovarian reserve was evaluated by measuring anti-mullerian hormone levels from serum samples taken from the patients before the operation and 6 weeks after the operation. Ovarian doppler flow were evaluated by measuring the ovarian artery pulsatility index with transvaginal ultrasonography preoperatively, postoperative days 2 and postoperative weeks 6 . In our study, it was determined that ovarian functions may be negatively affected in the acute period after salpingectomy operation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| perioperative ovarian arter pulsatility index(PI)(right and left), perioperative AMH levels | – | Procedure: bilateral salpingectomy, ovarian arter doppler ultrasonography |
| postoperative days 2 ovarian arter pulsatility index (PI) (right and left) | – | Procedure: bilateral salpingectomy, ovarian arter doppler ultrasonography |
| postop. weeks 6 ovarian arter pulsatility index(PI)(right and left), postop. weeks 6 AMH levels | – | Procedure: bilateral salpingectomy, ovarian arter doppler ultrasonography |
Who may qualify
- Ages
- 37 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Serum samples will be separated from routine blood samples taken from patients who apply to the outpatient clinic and will undergo salpingectomy within the indication, during perioperative preparation and at the 6th week postoperatively, after patient consent is obtained. This serum sample will be taken into an Eppendorf tube and kept at -40˚C for later AMH levels to be studied. Ovarian artery pulsatility index values measured during the patient's perioperative and postoperative routine ultrasonographic examination and weeks 6 postoperative control will be recorded.
Key inclusion criteria (5 listed)
- Women between the ages of 37-45 with continuing menstrual cycles (37 and 45 included)
- Patients who will undergo uterine surgery for benign reasons or who will undergo salpingectomy only due to hydrosalpinx, ectopic pregnancy, tubo-ovarian abscess
- Patients who have not had ovarian surgery before
- Those without menopause and premature ovarian failure
- Patients who accept the study
Key exclusion criteria (7 listed)
- Age younger than 37 or older than 45
- Those who want to withdraw from the study
- Those who do not come for follow-up examination
- Use of drugs that affect ovarian reserve
- Any surgical procedure performed on the ovaries during the operation
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 |
|---|---|---|
| bilateral salpingectomy, ovarian arter doppler ultrasonographyThe effect of salpingectomy operation on ovarian reserve | Procedure or surgery | perioperative ovarian arter pulsatility index(PI)(right and left), perioperative AMH levels, postop. weeks 6 ovarian arter pulsatility index(PI)(right and left), postop. weeks 6 AMH levels, postoperative days 2 ovarian arter pulsatility index (PI) (right and left) |
Primary outcome
right ovarian arter pı
Time frame: perioperative, postoperative days 2 , postoperative weeks 6
rate of 0,87/ 0,84/ 0,76
left ovarian arter pı
Time frame: perioperative, postoperative days 2, postoperative weeks 6
rate of 0,89/ 0,79/ 0.80
AMH levels
Time frame: perioperative-postoperative weeks 6
Concentration of 1 ng/mL / 0,79 ng/mL
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 3 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Ovarian Insufficiency
RecruitingObservational study
Longitudinal Study of Ultra-rare Inherited Metabolic and Degenerative Neurological Diseases.
Inherited Disease, Rare Diseases
RecruitingObservational study
Proteomic and Biological Characterisation of Plasma for the Study of Changes Following Ovarian Reactivation Treatment
Poor Ovarian Response, Ovarian Reactivation
RecruitingPhase 2
Autologous Hair Follicle-Derived Secretome and Platelet-Rich Plasma for Premature Ovarian Insufficiency
Premature Ovarian Insufficiency, POI
RecruitingObservational study
Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
Turner Syndrome, Post-menarcheal Adolescents
Not yet recruitingPhase 1
Oral GDC-0077 in Premature Ovarian Insufficiency
Primary Ovarian Insufficiency
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Insufficiency, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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 5 inclusion and 7 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 3 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 Turkey (Türkiye). 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?
right ovarian arter pı (time frame: perioperative, postoperative days 2 , postoperative weeks 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2025.