NCT01782807

Brief Summary

The impact of Hysterectomy with preservation of the ovaries on ovarian function has long been controversial. studies have shown conflicting data regarding ovarian function after simple Hysterectomy. In recent years, there is a growing evidence that Salpingectomy or Fimbriectomy may have preventive value reducing Ovarian and Primary Peritoneal carcinoma, but the safety and the consequences regarding ovarian function have yet to be established. The aim of this study is to evaluate ovarian function after Hysterectomy alone Vs. Hysterectomy combined with salpingectomy or fimbriectomy

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 4, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Last Updated

February 4, 2013

Status Verified

June 1, 2011

Enrollment Period

2.7 years

First QC Date

January 31, 2013

Last Update Submit

January 31, 2013

Conditions

Ovarian Function Insufficiency

Keywords

Ovarian functionHysterectomySalpingectomyAnti mullerian hormone

Outcome Measures

Primary Outcomes (1)

  • Ovarian function

    ovarian function measured by FSH , AMH and follicule count on ultra-sound

    60 days post-operative

Study Arms (2)

Hysterectomy

NO INTERVENTION

Hysterectomy without oophorectomy or salpingectomy

Hysterctomy with salpingectomy or fimbriectomy

EXPERIMENTAL

Salpingectomy or Fimbriectomy

Procedure: Salpingectomy or Fimbriectomy

Interventions

Salpingectomy or FimbriectomyPROCEDURE
Hysterctomy with salpingectomy or fimbriectomy

Eligibility Criteria

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

You may qualify if:

  • Women undergoing Hysterectomy for Benign In dication (eg. Uterus Myomatous) before menopause

You may not qualify if:

  • Menopause
  • known or suspected malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaplan Medical Center

Rehovot, Israel

RECRUITING

Related Publications (6)

  • Maseela T, Scheele R. [Hysterosalpingectomy. A contribution to the prevention of primary tubal neoplasms]. Fortschr Med. 1980 Jun 5;98(21):818-22. German.

    PMID: 7409710BACKGROUND

  • Zalel Y, Lurie S, Beyth Y, Goldberger S, Tepper R. Is it necessary to perform a prophylactic oophorectomy during hysterectomy? Eur J Obstet Gynecol Reprod Biol. 1997 May;73(1):67-70. doi: 10.1016/s0301-2115(97)02702-4.

    PMID: 9175692BACKGROUND

  • Morse AN, Hammer RA, Walter AJ, Baker S, Magtibay PM. Does hysterectomy without adnexectomy in patients with prior tubal interruption increase the risk of subsequent hydrosalpinx? Am J Obstet Gynecol. 2002 Dec;187(6):1483-5; discussion 1485-6. doi: 10.1067/mob.2002.130212.

    PMID: 12501050BACKGROUND

  • Farquhar CM, Sadler L, Harvey SA, Stewart AW. The association of hysterectomy and menopause: a prospective cohort study. BJOG. 2005 Jul;112(7):956-62. doi: 10.1111/j.1471-0528.2005.00696.x.

    PMID: 15957999BACKGROUND

  • Riedel HH, Lehmann-Willenbrock E, Semm K. Ovarian failure phenomena after hysterectomy. J Reprod Med. 1986 Jul;31(7):597-600.

    PMID: 3746790BACKGROUND

  • Bulent Tiras M, Noyan V, Ozdemir H, Guner H, Yildiz A, Yildirim M. The changes in ovarian hormone levels and ovarian artery blood flow rate after laparoscopic tubal sterilization. Eur J Obstet Gynecol Reprod Biol. 2001 Dec 1;99(2):219-21. doi: 10.1016/s0301-2115(01)00410-9.

    PMID: 11788175BACKGROUND

MeSH Terms

Interventions

SalpingectomySterilization, Tubal

Intervention Hierarchy (Ancestors)

Gynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, OperativeSterilization, Reproductive

Central Study Contacts

Alon Ben- Arie, MD

CONTACT

00-972-50-2460001abenarie@hotmail.com

Yael Naaman, MD

CONTACT

00-972-52-3499377yaelnaa@gmail.con

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director of Kaplan Medical Center

Study Record Dates

First Submitted

January 31, 2013

First Posted

February 4, 2013

Study Start

October 1, 2011

Primary Completion

June 1, 2014

Last Updated

February 4, 2013

Record last verified: 2011-06

Locations

IL(1)