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

Radboud University Medical Center

Status: Invitation-only

Conditions: Menopause; Salpingectomy; Tubal Ligation

Treatments: Procedure: Opportunistic salpingectomy / bilateral salpingectomy

Study type: Observational

Funder types: Other

Identifiers

NCT04757922

2020-6885

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,200 estimated patients

Sex: Female

Ages: 30 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,200 participants in 2 patient groups

Intervention: bilateral salpingectomy

Description:

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.

Treatment:

Procedure: Opportunistic salpingectomy / bilateral salpingectomy

Control: tubal ligation or no sterilization

Description:

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.