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Enrolling by Invitation

NCT Number: NCT04757922

Stop Ovarian Cancer Young; Effect of the Opportunistic Salpingectomy on Age of Menopause

The aim of this study is to evaluate the long-term safety of on the onset of menopause.

Enrolling by Invitation

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Key information

Conditions

Salpingectomy Menopause Tubal Ligation

Age range

30 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Catharina Ziekenhuis

Eindhoven, 5623 EJ, Netherlands

About this study

The aim of this study is to evaluate the long-term safety of on the onset of menopause. To investigate the effect of Opportunistic Salpingectomy on the age of menopause, we will compare age of menopause in women who underwent sterilization through opportunistic salpingectomy with a control group consisting of women who underwent sterilization by tubal ligation or who had no sterilization.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Intervention group

  • Undergoing an Opportunistic Salpingectomy as sterilization method
  • Premenopausal status at enrolment
  • Age between 30 and 45 years
  • Will have residual ovarian tissue after surgery
  • Able to understand the written or spoken Dutch language
  • Gives consent for participating in surveys

Control group

  • Premenopausal status at enrolment
  • Either sterilization by tubal ligation or no sterilization at all
  • Age between 35 and 45 years
  • Able to understand the written or spoken Dutch language
  • Gives consent for participating in surveys

Exclusion criteria

  • Postmenopausal status at enrolment
  • Under the age of 35 or above 45
  • Previous salpingectomy of oophorectomy
  • Previous hysterectomy
  • Women with abnormal karyotype (such as Turner Syndrome and Fragile X syndrome)
  • Underwent chemotherapy or radiation
  • Unable to understand the written or spoken Dutch language

Treatment and study plan

Opportunistic salpingectomy / bilateral salpingectomy

Procedure

An opportunistic salpingectomy refers to removal of the salpinges without the ovaries during (laparoscopic) interventions for benign (gynaecological) disease to reduce the number of ovarian cancer cases. Therefore, a so-called opportunistic salpingectomy is a method of female sterilization.

Primary outcomes

  1. Menopausal age

    Time frame: At end of follow-up (follow up ends at age of menopause with a maximum follow-up time of 15 years)

    The age of reaching natural menopause (e.g. last menstruation > 1 year ago )

Secondary outcomes

  1. Decision regret

    Time frame: 1 year post surgery and at age of menopause

    The decision regret regarding their choice of sterilization method.

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Catharina Ziekenhuis Eindhoven

Registry information

Acronym: STOPOVCAyoung

Important dates

Study start
2021
Primary completion
2035
Study completion
2036
First posted
Feb 17, 2021
Registry last updated
Jan 26, 2024

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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