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Ovarian Function After Hysterectomy With or Without Fimbriectomy or Salpingectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01782807
Recruitment Status : Unknown
Verified June 2011 by Lion Poles, Kaplan Medical Center.
Recruitment status was:  Recruiting
First Posted : February 4, 2013
Last Update Posted : February 4, 2013
Sponsor:
Information provided by (Responsible Party):
Lion Poles, Kaplan Medical Center

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


Condition or disease Intervention/treatment
Ovarian Function Insufficiency Procedure: Salpingectomy or Fimbriectomy

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Ovarian Function After Hysterectomy With or Without Fimbriectomy or Salpingectomy
Study Start Date : October 2011
Estimated Primary Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Hysterectomy
Hysterectomy without oophorectomy or salpingectomy
Experimental: Hysterctomy with salpingectomy or fimbriectomy
Salpingectomy or Fimbriectomy
Procedure: Salpingectomy or Fimbriectomy



Primary Outcome Measures :
  1. Ovarian function [ Time Frame: 60 days post-operative ]
    ovarian function measured by FSH , AMH and follicule count on ultra-sound



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Menopause
  • known or suspected malignancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01782807


Contacts
Contact: Alon Ben- Arie, MD 00-972-50-2460001 abenarie@hotmail.com
Contact: Yael Naaman, MD 00-972-52-3499377 yaelnaa@gmail.con

Locations
Israel
Kaplan Medical Center Recruiting
Rehovot, Israel
Contact: Alon Ben- Arie, MD       abenarie@hotmail.com   
Contact: Yael Naaman, MD       yaelnaa@gmail.com   
Principal Investigator: Alon Ben- Arie, MD         
Sponsors and Collaborators
Kaplan Medical Center

Publications:
Responsible Party: Lion Poles, Deputy Director of Kaplan Medical Center, Kaplan Medical Center
ClinicalTrials.gov Identifier: NCT01782807     History of Changes
Other Study ID Numbers: kmc0029-11
First Posted: February 4, 2013    Key Record Dates
Last Update Posted: February 4, 2013
Last Verified: June 2011

Keywords provided by Lion Poles, Kaplan Medical Center:
Ovarian function
Hysterectomy
Salpingectomy
Anti mullerian hormone