Ovarian Reserve Following Bilateral Salpingectomy Versus Tubal Ligation During Cesarean Section
Sponsor
Wolfson Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT02377128
Collaborator
(none)
45
3
Study Details
Study Description
Brief Summary
The aforementioned study was designed to evaluate short term ovarian reserve as assessed by anti-Mullerian hormone(AMH) levels following bilateral salpingectomy versus tubal ligation, as part of cesarean sections performed in women requesting future sterilization. The investigators aim to recruit 3 groups of 15 women undergoing elective cesarean section at the investigators' institution, 2 of which request sterilization (allocated to tubal ligation or bilateral salpingectomy) and one undergoing solely cesarean section. The groups will have blood drawn for AMH prior to the procedure and at a post-operation visit 8 weeks following. This is preformed in light of validated data offering better sterilization and possible diminished future risk of ovarian cancer with salpingectomy. Also, is has been proved to be just as safe as tubal ligation. This will be performed as a randomized controlled trial.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Study Start Date
:
Mar 1, 2015
Anticipated Primary Completion Date
:
Dec 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Bilateral salpingectomy Cesarean section with bilateral salpingectomy |
Procedure: Bilateral salpingectomy
Surgical bilateral removal of fallopian tubes (not involving ovaries)
|
| Active Comparator: Tubal ligation Cesarean section with tubal ligation |
Procedure: Tubal ligation
Bilateral ligation of fallopian tubes (not involving ovaries)
|
| No Intervention: No intervention Cesarean section with no additional intervention |
Outcome Measures
Primary Outcome Measures
- Change from baseline in Anti Mullerian hormone (AMH) levels ng/mL at 8 weeks [Baseline and 8 weeks following surgery]
AMH levels
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Women undergoing elective cesrean section at the investigators' institution, requesting sterilization, willing to have blood withdrawn for AMH levels prior to surgery, willing to participate in 8 weeks post-operation follow up with blood withdrawn
Exclusion Criteria:
- Non-elective cesarean section, non willing to have blood withdrawn or participate in follow up, prior salpingectomy, prior premature ovarian failure/egg donation
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Wolfson Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Committee opinion no. 620: Salpingectomy for ovarian cancer prevention. Obstet Gynecol. 2015 Jan;125(1):279-281. doi: 10.1097/01.AOG.0000459871.88564.09. Erratum in: Obstet Gynecol. 2016 Feb;127(2):405. Obstet Gynecol. 2016 Feb;127(2):405.
- Erickson BK, Conner MG, Landen CN Jr. The role of the fallopian tube in the origin of ovarian cancer. Am J Obstet Gynecol. 2013 Nov;209(5):409-14. doi: 10.1016/j.ajog.2013.04.019. Epub 2013 Apr 10. Review.
- Falconer H, Yin L, Grönberg H, Altman D. Ovarian cancer risk after salpingectomy: a nationwide population-based study. J Natl Cancer Inst. 2015 Jan 27;107(2). pii: dju410. doi: 10.1093/jnci/dju410. Print 2015 Feb.
- Findley AD, Siedhoff MT, Hobbs KA, Steege JF, Carey ET, McCall CA, Steiner AZ. Short-term effects of salpingectomy during laparoscopic hysterectomy on ovarian reserve: a pilot randomized controlled trial. Fertil Steril. 2013 Dec;100(6):1704-8. doi: 10.1016/j.fertnstert.2013.07.1997. Epub 2013 Aug 29.
- Ghezzi F, Cromi A, Siesto G, Bergamini V, Zefiro F, Bolis P. Infectious morbidity after total laparoscopic hysterectomy: does concomitant salpingectomy make a difference? BJOG. 2009 Mar;116(4):589-93. doi: 10.1111/j.1471-0528.2008.02085.x.
- Kamran MW, Vaughan D, Crosby D, Wahab NA, Saadeh FA, Gleeson N. Opportunistic and interventional salpingectomy in women at risk: a strategy for preventing pelvic serous cancer (PSC). Eur J Obstet Gynecol Reprod Biol. 2013 Sep;170(1):251-4. doi: 10.1016/j.ejogrb.2013.06.030. Epub 2013 Jul 21.
- McAlpine JN, Hanley GE, Woo MM, Tone AA, Rozenberg N, Swenerton KD, Gilks CB, Finlayson SJ, Huntsman DG, Miller DM; Ovarian Cancer Research Program of British Columbia. Opportunistic salpingectomy: uptake, risks, and complications of a regional initiative for ovarian cancer prevention. Am J Obstet Gynecol. 2014 May;210(5):471.e1-11. doi: 10.1016/j.ajog.2014.01.003. Epub 2014 Jan 9.
- Morelli M, Venturella R, Mocciaro R, Di Cello A, Rania E, Lico D, D'Alessandro P, Zullo F. Prophylactic salpingectomy in premenopausal low-risk women for ovarian cancer: primum non nocere. Gynecol Oncol. 2013 Jun;129(3):448-51. doi: 10.1016/j.ygyno.2013.03.023. Epub 2013 Apr 2.
- Peterson HB, Xia Z, Hughes JM, Wilcox LS, Tylor LR, Trussell J. The risk of ectopic pregnancy after tubal sterilization. U.S. Collaborative Review of Sterilization Working Group. N Engl J Med. 1997 Mar 13;336(11):762-7.
- Rosenblatt KA, Thomas DB. Reduced risk of ovarian cancer in women with a tubal ligation or hysterectomy. The World Health Organization Collaborative Study of Neoplasia and Steroid Contraceptives. Cancer Epidemiol Biomarkers Prev. 1996 Nov;5(11):933-5.
- Sezik M, Ozkaya O, Demir F, Sezik HT, Kaya H. Total salpingectomy during abdominal hysterectomy: effects on ovarian reserve and ovarian stromal blood flow. J Obstet Gynaecol Res. 2007 Dec;33(6):863-9.
Responsible Party:
Hadas Ganer Herman,
Dr.,
Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT02377128
Other Study ID Numbers:
- 0028-15-WOMC
First Posted:
Mar 3, 2015
Last Update Posted:
Apr 29, 2016
Last Verified:
Apr 1, 2016