Laparoscopic SalpingectomySALPOVANCT02284711
Impact of Salpingectomy on Ovarian Reserve
A study testing Bipolar electric energy and ultrasound energy in people with Laparoscopic Salpingectomy, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Laparoscopic Salpingectomy
- What is being tested?
- Bipolar electric energy and ultrasound energy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- 9 Mar 2015to 16 Oct 2020
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female subjects aged 18
- Scheduled surgery: bilateral laparoscopic salpingectomy associated to hysterectomy for benign indication
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Laparoscopic Salpingectomy
- Being tested
- Bipolar electric energy, ultrasound energy
- Keywords
- salpingectomy, ovarian reserve, coagulation technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bipolar electric energyDevice
Coagulation during salpingectomy using conventional bipolar electric energy
ultrasound energyDevice
Coagulation during salpingectomy using UltraCision HARMONIC ACE® ultrasound energy
| Study group | Role | What they receive |
|---|---|---|
| Bipolar | Active comparator | Coagulation during salpingectomy using conventional bipolar electric energy Receives: Device: Bipolar electric energy |
| Ultrasound | Active comparator | Coagulation during salpingectomy using UltraCision HARMONIC ACE® ultrasound energy Receives: Device: ultrasound energy |
What is being measured
The primary outcome is the main question the study is designed to answer.
AMH level
Measured: 3 months post-surgery
Secondary outcomes (3)
AMH level
Measured: 1 month post-surgery
index of vascular resistance in the ovarian vessels
Measured: 1 and 3 months post-surgery
menopausal quality of life score
Measured: 1 and 3 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study start9 Mar 2015
- Primary completion16 Oct 2020
- Study completion16 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic SalpingectomyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02284711
- Sponsor's protocol ID
- 69HCL14_0166
- Other IDs
- 2014-A01218-39
- Acronym
- SALPOVA
- Status last verified
- Aug 2025
- First submitted
- 4 Nov 2014
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Lamblin G, Thiberville G, Bansac Lamblin A, Moret S, Du-Mesnildot P, Rannou C, Ploton I, Chabert P, Chene G. [What haemostatic technique should we use for opportunistic salpingectomy during benign laparoscopic hysterectomy?]. Gynecol Obstet Fertil Senol. 2017 Sep;45(9):453-459. doi: 10.1016/j.gofs.2017.06.017. Epub 2017 Jul 27. French.
PubMed 28757104
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Salpingectomy on Ovarian Reserve, With Comparison Between Two Coagulation Techniques
- ClinicalTrials.gov ID
- NCT02284711
- Acronym / sponsor ID
- SALPOVA / 69HCL14_0166
- Conditions
- Laparoscopic Salpingectomy
- Keywords
- salpingectomy, ovarian reserve, coagulation technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 9 Mar 2015 (actual)
- Primary completion
- 16 Oct 2020 (actual)
- Study completion
- 16 Oct 2020 (actual)
- First posted
- 6 Nov 2014 (estimated)
- 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bipolar | Active comparator | Device: Bipolar electric energyCoagulation during salpingectomy using conventional bipolar electric energy |
| Ultrasound | Active comparator | Device: ultrasound energyCoagulation during salpingectomy using UltraCision HARMONIC ACE® ultrasound energy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female subjects aged 18
- Scheduled surgery: bilateral laparoscopic salpingectomy associated to hysterectomy for benign indication
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Bipolar electric energyCoagulation during salpingectomy using conventional bipolar electric energy | Device | Bipolar |
| ultrasound energyCoagulation during salpingectomy using UltraCision HARMONIC ACE® ultrasound energy | Device | Ultrasound |
Primary outcome
AMH level
Time frame: 3 months post-surgery
3 secondary outcomes
AMH level
Time frame: 1 month post-surgery
index of vascular resistance in the ovarian vessels
Time frame: 1 and 3 months post-surgery
menopausal quality of life score
Time frame: 1 and 3 months post-surgery
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 2 Sep 2025.
- Results publication: PubMed 28757104Lamblin G, Thiberville G, Bansac Lamblin A, Moret S, Du-Mesnildot P, Rannou C, Ploton I, Chabert P, Chene G. [What haemostatic technique should we use for opportunistic salpingectomy during benign laparoscopic hysterectomy?]. Gynecol Obstet Fertil Senol. 2017 Sep;45(9):453-459. doi: 10.1016/j.gofs.2017.06.017. Epub 2017 Jul 27. French.
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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?
A study testing Bipolar electric energy and ultrasound energy in people with Laparoscopic Salpingectomy, run by Hospices Civils de Lyon at 1 site in France.
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 8 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 2 Sep 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 France. 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?
AMH level (time frame: 3 months post-surgery). 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 NCT02284711, which also lists 1 linked publication.
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 2 Sep 2025.