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Clinical Trials/NCT04757922
NCT04757922
Enrolling By Invitation
Not Applicable

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

Radboud University Medical Center1 site in 1 country1,200 target enrollmentMarch 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Salpingectomy
Sponsor
Radboud University Medical Center
Enrollment
1200
Locations
1
Primary Endpoint
Menopausal age
Status
Enrolling By Invitation
Last Updated
2 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
January 1, 2036
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

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

  • Decision regret(1 year post surgery and at age of menopause)

Study Sites (1)

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