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

January 25, 2024 updated by: Radboud University Medical Center
The aim of this study is to evaluate the long-term safety of on the onset of menopause.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Eindhoven, Netherlands, 5623 EJ
        • Catharina Ziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 43 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Women who underwent sterilization (bilateral salpingectomy / tubal ligation) supplemented by friend/acquaintances, around the same age, who are not planning to undergo sterilization.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intervention: bilateral salpingectomy
Premenopausal women between 30 and 45 years of age, who will undergo sterilization through Opportunistic Salpingectomy will be asked to participate in the STOPOVCAyoung study.
Procedure: Opportunistic salpingectomy / bilateral salpingectomy
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.
Control: tubal ligation or no sterilization
The control group will consists of women who chose for sterilization by clips/tubal ligation supplemented by friend/acquaintances, around the same age, who are not planning to undergo sterilization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 )
At end of follow-up (follow up ends at age of menopause with a maximum follow-up time of 15 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decision regret
Time Frame: 1 year post surgery and at age of menopause
The decision regret regarding their choice of sterilization method.
1 year post surgery and at age of menopause

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Catharina Ziekenhuis Eindhoven

Investigators

  • Principal Investigator: Jurgen MJ Piek, MD, PhD, Catharina Ziekenhuis
  • Principal Investigator: Joanne A de Hullu, MD, PhD, University Medical Center Nijmegen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Estimated)

January 1, 2035

Study Completion (Estimated)

January 1, 2036

Study Registration Dates

First Submitted

February 5, 2021

First Submitted That Met QC Criteria

February 16, 2021

First Posted (Actual)

February 17, 2021

Study Record Updates

Last Update Posted (Estimated)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2020-6885

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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