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NCT Number: NCT02284711

Impact of Salpingectomy on Ovarian Reserve

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon - HFME

Lyon, 69003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bipolar electric energy

Device

Coagulation during salpingectomy using conventional bipolar electric energy

ultrasound energy

Device

Coagulation during salpingectomy using UltraCision HARMONIC ACE® ultrasound energy

Primary outcomes

  1. AMH level

    Time frame: 3 months post-surgery

Secondary outcomes

  1. AMH level

    Time frame: 1 month post-surgery

  2. index of vascular resistance in the ovarian vessels

    Time frame: 1 and 3 months post-surgery

  3. menopausal quality of life score

    Time frame: 1 and 3 months post-surgery

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: SALPOVA

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Nov 6, 2014
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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