- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01782807
Ovarian Function After Hysterectomy With or Without Fimbriectomy or Salpingectomy
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alon Ben- Arie, MD
- Phone Number: 00-972-50-2460001
- Email: abenarie@hotmail.com
Study Contact Backup
- Name: Yael Naaman, MD
- Phone Number: 00-972-52-3499377
- Email: yaelnaa@gmail.con
Study Locations
-
-
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Rehovot, Israel
- Recruiting
- Kaplan Medical Center
-
Contact:
- Alon Ben- Arie, MD
- Email: abenarie@hotmail.com
-
Contact:
- Yael Naaman, MD
- Email: yaelnaa@gmail.com
-
Principal Investigator:
- Alon Ben- Arie, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women undergoing Hysterectomy for Benign In dication (eg. Uterus Myomatous) before menopause
Exclusion Criteria:
- Menopause
- known or suspected malignancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Hysterectomy
Hysterectomy without oophorectomy or salpingectomy
|
|
Experimental: Hysterctomy with salpingectomy or fimbriectomy
Salpingectomy or Fimbriectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ovarian function
Time Frame: 60 days post-operative
|
ovarian function measured by FSH , AMH and follicule count on ultra-sound
|
60 days post-operative
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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. doi: 10.1016/s0301-2115(97)02702-4.
- 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.
- 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.
- 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. doi: 10.1016/s0301-2115(01)00410-9.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- kmc0029-11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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