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

NCT ID: NCT04757922

Last Updated: 2024-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2036-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Salpingectomy Tubal Ligation Menopause

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention: 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.

Opportunistic salpingectomy / bilateral salpingectomy

Intervention Type PROCEDURE

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.

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jurgen MJ Piek, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Catharina Ziekenhuis

Joanne A de Hullu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Nijmegen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Catharina Ziekenhuis

Eindhoven, , Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 11745677 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24518912 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25628372 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31456223 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29852159 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27261215 (View on PubMed)

Gelderblom ME, IntHout J, Hermens RPMG, Coppus SFPJ, Ebisch I, van Ginkel AA, van de Laar R, de Lange N, Maassen M, Pijlman B, Smedts HPM, Vos MC, Beerendonk CCM, de Hullu JA, Piek JMJ. STop OVarian CAncer (STOPOVCA) young: Protocol for a multicenter follow-up study to determine the long-term effects of opportunistic salpingectomy on age at menopause. Maturitas. 2022 May;159:62-68. doi: 10.1016/j.maturitas.2022.01.006. Epub 2022 Jan 15.

Reference Type DERIVED
PMID: 35337614 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-6885

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.