NCT02669498

Brief Summary

Two recently published articles need to be cited to explain the rationale for our study since both studies conclude with contrary findings: The first one is "The post-reproductive Fallopian tube: better removed?" and the other is termed "Factors associated with age of onset and type of menopause in a cohort of UK women". In essence, while Dietl et al suggest to remove the Fallopian tube routinely in every hysterectomy and every sterilization procedure after 35 yrs of age, Pokoradi et al showed that pelvic surgical procedures and even simple tubal sterilization are associated with an earlier menopause. Hence, this is an important issue as early menopause leads to adverse health status.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 1, 2016

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

September 1, 2022

Status Verified

August 1, 2022

Enrollment Period

8.1 years

First QC Date

January 25, 2016

Last Update Submit

August 29, 2022

Conditions

Pelvic SurgeryRoutine Fallopian Tube Removal

Outcome Measures

Primary Outcomes (1)

  • Longitudinal changes of FSH pre- and post-operatively

    Follicle-stimulating hormone (U/l)

    6 weeks

Secondary Outcomes (7)

  • Longitudinal changes of AMH

    6 weeks

  • Longitudinal changes of LH

    6 weeks

  • Longitudinal changes of E2

    6 weeks

  • Longitudinal changes of FSH

    1 year

  • Longitudinal changes of AMH

    1 year

  • +2 more secondary outcomes

Study Arms (2)

Surgery with fallopian tube removal

ACTIVE COMPARATOR

Patients receiving routine fallopian tube removal during pelvic surgery after randomization.

Procedure: Routine fallopian tube removal

Surgery without fallopian tube removal

NO INTERVENTION

Fallopian tubes are not removed during pelvic surgery after randomization.

Interventions

Routine fallopian tube removalPROCEDURE

Fallopian tubes are removed by dissection of the Mesosalpinx.

Surgery with fallopian tube removal

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • benign indication for hysterectomy
  • informed consent

You may not qualify if:

  • Menopause
  • Pregnancy
  • Previous pelvic surgery (hysterectomy, salpingectomy, tubal ligation,...)
  • malignancy
  • hormone replacement therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kantonsspital Baden

Baden, 5404, Switzerland

Location

University Women's Hospital

Bern, 3010, Switzerland

Location

Related Publications (2)

  • Dietl J, Wischhusen J, Hausler SF. The post-reproductive Fallopian tube: better removed? Hum Reprod. 2011 Nov;26(11):2918-24. doi: 10.1093/humrep/der274. Epub 2011 Aug 16.

    PMID: 21849300RESULT

  • Pokoradi AJ, Iversen L, Hannaford PC. Factors associated with age of onset and type of menopause in a cohort of UK women. Am J Obstet Gynecol. 2011 Jul;205(1):34.e1-13. doi: 10.1016/j.ajog.2011.02.059. Epub 2011 Feb 27.

    PMID: 21514918RESULT

Study Officials

  • Michael D Mueller, Prof.

    University Women's Hospital Bern, Switzerland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2016

First Posted

February 1, 2016

Study Start

November 1, 2013

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

September 1, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

CH(2)