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

Menopause Clinical Trial

— STOPOVCAyoung  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04757922
• Other study ID #: 2020-6885
• Status: Enrolling by invitation
• Start date: March 1, 2021
• Est. completion date: January 1, 2036

Study information

• Verified date: January 2024
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1200
• Est. completion date: January 1, 2036
• Est. primary completion date: January 1, 2035
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Menopause
• Salpingectomy
• Tubal Ligation

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Catharina Ziekenhuis	Eindhoven

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University Medical Center	Catharina Ziekenhuis Eindhoven

Country where clinical trial is conducted

Netherlands, 

References & Publications (6)

Falconer H, Yin L, Gronberg H, Altman D. Ovarian cancer risk after salpingectomy: a nationwide population-based study. J Natl Cancer Inst. 2015 Jan 27;107(2):dju410. doi: 10.1093/jnci/dju410. Print 2015 Feb. — View Citation

Hanley GE, Kwon JS, Finlayson SJ, Huntsman DG, Miller D, McAlpine JN. Extending the safety evidence for opportunistic salpingectomy in prevention of ovarian cancer: a cohort study from British Columbia, Canada. Am J Obstet Gynecol. 2018 Aug;219(2):172.e1-172.e8. doi: 10.1016/j.ajog.2018.05.019. Epub 2018 May 28. — View Citation

McAlpine JN, Tone AA, Hanley GE. Opportunistic Salpingectomy: We Chose to Act, Not Wait. J Obstet Gynaecol Can. 2016 May;38(5):425-7. doi: 10.1016/j.jogc.2016.04.084. Epub 2016 May 6. No abstract available. — View Citation

Piek JM, van Diest PJ, Zweemer RP, Jansen JW, Poort-Keesom RJ, Menko FH, Gille JJ, Jongsma AP, Pals G, Kenemans P, Verheijen RH. Dysplastic changes in prophylactically removed Fallopian tubes of women predisposed to developing ovarian cancer. J Pathol. 2001 Nov;195(4):451-6. doi: 10.1002/path.1000. — View Citation

Reade CJ, McVey RM, Tone AA, Finlayson SJ, McAlpine JN, Fung-Kee-Fung M, Ferguson SE. The fallopian tube as the origin of high grade serous ovarian cancer: review of a paradigm shift. J Obstet Gynaecol Can. 2014 Feb;36(2):133-140. doi: 10.1016/S1701-2163(15)30659-9. — View Citation

van Lieshout LAM, Steenbeek MP, De Hullu JA, Vos MC, Houterman S, Wilkinson J, Piek JM. Hysterectomy with opportunistic salpingectomy versus hysterectomy alone. Cochrane Database Syst Rev. 2019 Aug 28;8(8):CD012858. doi: 10.1002/14651858.CD012858.pub2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Menopausal age	The age of reaching natural menopause (e.g. last menstruation > 1 year ago )	At end of follow-up (follow up ends at age of menopause with a maximum follow-up time of 15 years)
Secondary	Decision regret	The decision regret regarding their choice of sterilization method.	1 year post surgery and at age of menopause