Ovarian Function After Hysterectomy With or Without Fimbriectomy or Salpingectomy

This study is currently recruiting participants.

Verified June 2011 by Kaplan Medical Center

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:

MedlinePlus related topics: Hysterectomy

U.S. FDA Resources

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

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:

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

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.

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.

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.

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

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.

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 May 19, 2013

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