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

N/AEnrolling By InvitationNCT04757922

Radboud University Medical Center1,200 enrolled

Overview

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

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

1,200

Conditions

Salpingectomy Tubal Ligation Menopause

Interventions

Opportunistic salpingectomy / bilateral salpingectomyPROCEDURE

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.

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Catharina Ziekenhuis

Eindhoven, Netherlands

Outcomes

Primary Outcomes

Menopausal age

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

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

Secondary Outcomes

Decision regret

The decision regret regarding their choice of sterilization method.

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

Data from ClinicalTrials.gov

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