Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 5 of 21 for:    salpingectomy

Ovarian Function After Hysterectomy With or Without Fimbriectomy or Salpingectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Kaplan Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Lion Poles, Kaplan Medical Center
ClinicalTrials.gov Identifier:
NCT01782807
First received: January 31, 2013
Last updated: NA
Last verified: June 2011
History: No changes posted
  Purpose

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 Intervention
Ovarian Function Insufficiency
Procedure: Salpingectomy or Fimbriectomy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Ovarian Function After Hysterectomy With or Without Fimbriectomy or Salpingectomy

Resource links provided by NLM:


Further study details as provided by Kaplan Medical Center:

Primary Outcome Measures:
  • Ovarian function [ Time Frame: 60 days post-operative ] [ Designated as safety issue: No ]
    ovarian function measured by FSH , AMH and follicule count on ultra-sound


Estimated Enrollment: 60
Study Start Date: October 2011
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Hysterectomy
Hysterectomy without oophorectomy or salpingectomy
Experimental: Hysterctomy with salpingectomy or fimbriectomy
Salpingectomy or Fimbriectomy
Procedure: Salpingectomy or Fimbriectomy

  Eligibility

Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: January 31, 2013
Last Updated: January 31, 2013
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on November 20, 2014