The Effect of Salpingectomy Operation on Ovarian Reserve

March 31, 2025 updated by: Derya Öztürk, Dokuz Eylul University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İzmir, Turkey, 35000
        • Dokuz Eylul University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  1. Women between the ages of 37-45 with continuing menstrual cycles (37 and 45 included)
  2. Patients who will undergo uterine surgery for benign reasons or who will undergo salpingectomy only due to hydrosalpinx, ectopic pregnancy, tubo-ovarian abscess
  3. Patients who have not had ovarian surgery before
  4. Those without menopause and premature ovarian failure
  5. Patients who accept the study

Exclusion Criteria:

  1. Age younger than 37 or older than 45
  2. Those who want to withdraw from the study
  3. Those who do not come for follow-up examination
  4. Use of drugs that affect ovarian reserve
  5. Any surgical procedure performed on the ovaries during the operation
  6. No menstrual bleeding in the last year
  7. Patients who received radiotherapy and hormonal therapy within 3 months before surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
perioperative ovarian arter pulsatility index(PI)(right and left), perioperative AMH levels
Procedure: bilateral salpingectomy, ovarian arter doppler ultrasonography
The effect of salpingectomy operation on ovarian reserve
postoperative days 2 ovarian arter pulsatility index (PI) (right and left)
Procedure: bilateral salpingectomy, ovarian arter doppler ultrasonography
The effect of salpingectomy operation on ovarian reserve
postop. weeks 6 ovarian arter pulsatility index(PI)(right and left), postop. weeks 6 AMH levels
Procedure: bilateral salpingectomy, ovarian arter doppler ultrasonography
The effect of salpingectomy operation on ovarian reserve

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
right ovarian arter pı
Time Frame: perioperative, postoperative days 2 , postoperative weeks 6
rate of 0,87/ 0,84/ 0,76
perioperative, postoperative days 2 , postoperative weeks 6
left ovarian arter pı
Time Frame: perioperative, postoperative days 2, postoperative weeks 6
rate of 0,89/ 0,79/ 0.80
perioperative, postoperative days 2, postoperative weeks 6
AMH levels
Time Frame: perioperative-postoperative weeks 6
Concentration of 1 ng/mL / 0,79 ng/mL
perioperative-postoperative weeks 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dokuz Eylul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 27, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 3, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 5, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SOORAMHODU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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