Impact of Salpingectomy on Ovarian Reserve (SALPOVA)

August 28, 2025 updated by: Hospices Civils de Lyon

Impact of Salpingectomy on Ovarian Reserve, With Comparison Between Two Coagulation Techniques

Epithelial cancer of the ovaries is the most severe form of gynecologic cancer; a significant proportion of ovarian cancers originate from the Fallopian tube. Guidelines therefore now recommend systematically associating prophylactic salpingectomy to benign hysterectomy. The principal objective of the present study is to assess the impact of salpingectomy on ovarian reserve by anti-Müllerian hormone (AMH) assay and calculating the Doppler index of vascular resistance in the ovarian vessels. The secondary objective is to compare ovarian reserve results between two coagulation techniques used in salpingectomy: bipolar electric energy versus ultrasound.

The study design is single-center, prospective, before-and-after, with open randomization between two groups defined by coagulation technique.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

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

  • France
      • Lyon, France, 69003
        • Hospices Civils de Lyon - HFME

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female subjects aged 18
  • Scheduled surgery: bilateral laparoscopic salpingectomy associated to hysterectomy for benign indication

Exclusion Criteria:

  • Interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, evolutive disease, etc.
  • Pregnancy, ongoing or planned during the study period
  • History of bilateral salpingectomy
  • Salpingectomy associated with pelvic cancer
  • Oral hormonal contraception during the study period
  • Menopause
  • Inability to understand information provided
  • Not covered by a national health insurance scheme, prisoner or under administrative supervision.

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bipolar
Coagulation during salpingectomy using conventional bipolar electric energy
Device: Bipolar electric energy
Coagulation during salpingectomy using conventional bipolar electric energy
Active Comparator: Ultrasound
Coagulation during salpingectomy using UltraCision HARMONIC ACE® ultrasound energy
Device: ultrasound energy
Coagulation during salpingectomy using UltraCision HARMONIC ACE® ultrasound energy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AMH level
Time Frame: 3 months post-surgery
3 months post-surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
AMH level
Time Frame: 1 month post-surgery
1 month post-surgery
index of vascular resistance in the ovarian vessels
Time Frame: 1 and 3 months post-surgery
1 and 3 months post-surgery
menopausal quality of life score
Time Frame: 1 and 3 months post-surgery
1 and 3 months post-surgery

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 9, 2015

Primary Completion (Actual)

October 16, 2020

Study Completion (Actual)

October 16, 2020

Study Registration Dates

First Submitted

November 4, 2014

First Submitted That Met QC Criteria

November 4, 2014

First Posted (Estimated)

November 6, 2014

Study Record Updates

Last Update Posted (Estimated)

September 2, 2025

Last Update Submitted That Met QC Criteria

August 28, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL14_0166
  • 2014-A01218-39 (Other Identifier: ID-RCB)

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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