SalpingectomySTOPOVCAyoungNCT04757922
Stop Ovarian Cancer Young; Effect of the Opportunistic Salpingectomy on Age of Menopause
An observational study of Salpingectomy and Tubal Ligation, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The aim of this study is to evaluate the long-term safety of on the onset of menopause. Read more about this study
- Who is it for?
- Ages 30 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Salpingectomy, Tubal Ligation, Menopause
- What is being tested?
- Opportunistic salpingectomy / bilateral salpingectomy
- Type of treatment
- Surgery or procedure
- How many people
- 1,200 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2021to 1 Jan 2036
- How long will I take part?
- 15 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women who underwent sterilization (bilateral salpingectomy / tubal ligation) supplemented by friend/acquaintances, around the same age, who are not planning to undergo sterilization.
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The aim of this study is to evaluate the long-term safety of on the onset of menopause.
Read the 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.
- Conditions
- Salpingectomy, Tubal Ligation, Menopause
- Being tested
- Opportunistic salpingectomy / bilateral salpingectomy
- Keywords
- Salpingectomy, Sterilization, Tubal ligation, Opportunistic salpingectomy, Menopausal age
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opportunistic salpingectomy / bilateral salpingectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Opportunistic salpingectomy / bilateral salpingectomy | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menopausal age
The age of reaching natural menopause (e.g. last menstruation > 1 year ago )
Measured: At end of follow-up (follow up ends at age of menopause with a maximum follow-up time of 15 years)
Secondary outcomes (1)
Decision regret
The decision regret regarding their choice of sterilization method.
Measured: 1 year post surgery and at age of menopause
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start1 Mar 2021
- Primary completion1 Jan 2035 (estimated)
- Study completion1 Jan 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for SalpingectomyStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Catharina Ziekenhuis Eindhoven
- Responsible party
- Sponsor
- Investigators
- Jurgen MJ Piek, MD, PhD, Principal investigator, Catharina ZiekenhuisJoanne A de Hullu, MD, PhD, Principal investigator, University Medical Center Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757922
- Sponsor's protocol ID
- 2020-6885
- Acronym
- STOPOVCAyoung
- Status last verified
- Jan 2024
- First submitted
- 5 Feb 2021
- Last updated
- 26 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 11745677Reade 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.
PubMed 24518912Falconer 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.
PubMed 25628372van 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.
PubMed 31456223Hanley 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.
PubMed 29852159McAlpine 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.
PubMed 27261215Gelderblom 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.
PubMed 35337614
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stop Ovarian Cancer Young; Effect of the Opportunistic Salpingectomy on Age of Menopause
- ClinicalTrials.gov ID
- NCT04757922
- Acronym / sponsor ID
- STOPOVCAyoung / 2020-6885
- Conditions
- Salpingectomy, Tubal Ligation, Menopause
- Keywords
- Salpingectomy, Sterilization, Tubal ligation, Opportunistic salpingectomy, Menopausal age
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Catharina Ziekenhuis Eindhoven
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jan 2035 (estimated)
- Study completion
- 1 Jan 2036 (estimated)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the long-term safety of on the onset of menopause.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: bilateral salpingectomy | – | Procedure: Opportunistic salpingectomy / bilateral salpingectomyPremenopausal women between 30 and 45 years of age, who will undergo sterilization through Opportunistic Salpingectomy will be asked to participate in the STOPOVCAyoung study. |
| 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. |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women who underwent sterilization (bilateral salpingectomy / tubal ligation) supplemented by friend/acquaintances, around the same age, who are not planning to undergo sterilization.
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opportunistic salpingectomy / bilateral salpingectomyAn 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. | Procedure or surgery | Intervention: bilateral salpingectomy |
Primary outcome
Menopausal age
Time frame: 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 )
1 secondary outcome
Decision regret
Time frame: 1 year post surgery and at age of menopause
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Background: PubMed 11745677Piek 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.
- Background: PubMed 24518912Reade 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.
- Background: PubMed 25628372Falconer 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.
- Background: PubMed 31456223van 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.
- Background: PubMed 29852159Hanley 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.
- Background: PubMed 27261215McAlpine 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.
- Derived from this study: PubMed 35337614Gelderblom 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jurgen MJ Piek, MD, PhD principal investigator
Catharina Ziekenhuis
Joanne A de Hullu, MD, PhD principal investigator
University Medical Center Nijmegen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Salpingectomy and Tubal Ligation, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menopausal age (time frame: At end of follow-up (follow up ends at age of menopause with a maximum follow-up time of 15 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04757922, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2024.