Impact of Salpingectomy on Ovarian Reserve

NCT ID: NCT02284711

Last Updated: 2025-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-09

Study Completion Date

2020-10-16

Brief Summary

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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.

Detailed Description

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Conditions

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Laparoscopic Salpingectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Bipolar

Coagulation during salpingectomy using conventional bipolar electric energy

Group Type ACTIVE_COMPARATOR

Bipolar electric energy

Intervention Type DEVICE

Coagulation during salpingectomy using conventional bipolar electric energy

Ultrasound

Coagulation during salpingectomy using UltraCision HARMONIC ACE® ultrasound energy

Group Type ACTIVE_COMPARATOR

ultrasound energy

Intervention Type DEVICE

Coagulation during salpingectomy using UltraCision HARMONIC ACE® ultrasound energy

Interventions

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Bipolar electric energy

Coagulation during salpingectomy using conventional bipolar electric energy

Intervention Type DEVICE

ultrasound energy

Coagulation during salpingectomy using UltraCision HARMONIC ACE® ultrasound energy

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospices Civils de Lyon - HFME

Lyon, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 28757104 (View on PubMed)

Other Identifiers

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2014-A01218-39

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL14_0166

Identifier Type: -

Identifier Source: org_study_id

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