Ovarian Function After Hysterectomy With or Without Fimbriectomy or Salpingectomy

Ovarian Function Insufficiency Clinical Trial

Official title:

Ovarian Function After Hysterectomy With or Without Fimbriectomy or Salpingectomy

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01782807
• Other study ID #: kmc0029-11
• Status: Unknown status
• Phase: N/A
• First received: January 31, 2013
• Last updated: January 31, 2013
• Start date: October 2011

Study information

• Verified date: June 2011
• Source: Kaplan Medical Center
• Contact: Alon Ben- Arie, MD
• Phone: 00-972-50-2460001
• Email: abenarie[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 60
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Menopause

• known or suspected malignancy

Related Conditions & MeSH terms

• Ovarian Function Insufficiency

Intervention

Procedure:
• Salpingectomy or Fimbriectomy

Locations

Country	Name	City	State
Israel	Kaplan Medical Center	Rehovot

Sponsors (1)

Lead Sponsor	Collaborator
Kaplan Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (6)

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. — View Citation

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. — View Citation

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

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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ovarian function	ovarian function measured by FSH , AMH and follicule count on ultra-sound	60 days post-operative