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

• Conditions: Tubal Ligation; Menopause; Salpingectomy
• Interventions: Procedure: Opportunistic salpingectomy / bilateral salpingectomy

• Registration Number: NCT04757922
• Lead Sponsor: Radboud University Medical Center

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.

Study Timeline

• Study First Submitted: 2021-02-05
• Study First Submitted QC: 2021-02-16
• Study First Posted: 2021-02-17
• Study Start: 2021-03-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-26
• Primary Completion: 2035-01-01
• Study Completion: 2036-01-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 1200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention: bilateral salpingectomy	Opportunistic salpingectomy / 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.

Primary Outcome Measures

Name	Time	Method
Menopausal age	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 Outcome Measures

Name	Time	Method
Decision regret	1 year post surgery and at age of menopause	The decision regret regarding their choice of sterilization method.

Trial Locations

Locations (1)

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Netherlands