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

Sponsor

Radboud University Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04757922

Collaborator

Catharina Ziekenhuis Eindhoven (Other)

1,200

Enrollment

Location

178

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Salpingectomy Tubal Ligation Menopause	Procedure: Opportunistic salpingectomy / bilateral salpingectomy

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Jan 1, 2035

Anticipated Study Completion Date :

Jan 1, 2036

Arms and Interventions

Arm	Intervention/Treatment
Intervention: bilateral salpingectomy Premenopausal women between 35 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.

Arm

Intervention/Treatment

Intervention: bilateral salpingectomy

Premenopausal women between 35 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.

Outcome Measures

Primary Outcome Measures

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

Decision regret [1 year post surgery and at age of menopause]
The decision regret regarding their choice of sterilization method.

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Intervention group

Undergoing an Opportunistic Salpingectomy as sterilization method
Premenopausal status at enrolment
Age between 35 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Catharina Ziekenhuis	Eindhoven		Netherlands	5623 EJ

Sponsors and Collaborators

Radboud University Medical Center
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