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NCT Number: NCT01893086

Impact of Opportunistic Salpingectomy on Ovarian Reserve in Patients Undergoing Laparoscopic Hysterectomy

Recently, many gynecologic oncologists proposed that surgeons should consider opportunistic salpingectomy to prevent ovarian cancer for all patients undergoing hysterectomy for benign disease. However, the safety and the consequences regarding ovarian function after salpingectomy have not yet to be established. Therefore, the aim of this randomized controlled study is compare the ovarian reserve via anti-Müllerian hormone (AMH) between laparoscopic hysterectomy (LH) alone and LH combined with salpingectomy.

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Key information

Conditions

Benign Uterine Disease

Age range

19 year–52 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Keimyung University School of Medicine, Daegu, South Korea

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • women who were planning to undergo laparoscopic hysterectomy for benign uterine diseases
  • women aged between 19 and 52 years
  • women with regular menstruation (defined as the duration of menstrual cycle between 21 and 45 days)
  • women who were appropriated medical status for laparoscopic surgery

Exclusion criteria

  • any ovarian cysts requiring ovarian surgery
  • any suspicious findings of malignant diseases
  • history of prior salpingectomy or salpingo-oophorectomy
  • pregnant or menopausal status
  • preoperative serum anti-Müllerian hormone (AMH) < 0.30 ng/mL
  • use of hormonal treatments in the three months before surgery
  • any other endocrine disease (such as uncontrolled thyroid dysfunction, hyperprolactinemia, or Cushing syndrome)
  • an inability to understand and provide written informed consent.

Treatment and study plan

LH alone

Procedure

LH, laparoscopic hysterectomy

LH with opportunistic salpingectomy

Procedure

LH, laparoscopic hysterectomy

Primary outcomes

  1. Change in ovarian reserve

    Time frame: 3 months after surgery

    The primary outcome measure was the change of ovarian reserve, determined by the rate of decline in AMH level from before surgery to 3-month post-surgery with the following formula : decline rate (%) = 100 × (preoperative AMH level - postoperative AMH level) ÷ preoperative AMH level.

Sponsors and collaborators

Lead sponsor

CHA University

Other

Registry information

Official study title

Impact of Opportunistic Salpingectomy on Ovarian Reserve in Patients Undergoing Laparoscopic Hysterectomy: a Multi-center, Randomized Controlled Trial

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 8, 2013
Registry last updated
Jan 28, 2016

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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