Ovarian Reserve Following Bilateral Salpingectomy Versus Tubal Ligation During Cesarean Section

Ovarian Reserve Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02377128
• Other study ID #: 0028-15-WOMC
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 15, 2015
• Last updated: April 28, 2016
• Start date: March 2015

Study information

• Verified date: April 2016
• Source: Wolfson Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 45
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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undergoing elective cesrean section at the investigators' institution, requesting sterilization, willing to have blood withdrawn for AMH levels prior to surgery, willing to participate in 8 weeks post-operation follow up with blood withdrawn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• Non-elective cesarean section, non willing to have blood withdrawn or participate in follow up, prior salpingectomy, prior premature ovarian failure/egg donation

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Reserve

Intervention

Procedure:
• Bilateral salpingectomy
Surgical bilateral removal of fallopian tubes (not involving ovaries)
• Tubal ligation
Bilateral ligation of fallopian tubes (not involving ovaries)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

References & Publications (13)

Committee on Gynecologic Practice. Committee opinion no. 620: Salpingectomy for ovarian cancer prevention. Obstet Gynecol. 2015 Jan;125(1):279-81. doi: 10.1097/01.AOG.0000459871.88564.09. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Köninger A, Kauth A, Schmidt B, Schmidt M, Yerlikaya G, Kasimir-Bauer S, Kimmig R, Birdir C. Anti-Mullerian-hormone levels during pregnancy and postpartum. Reprod Biol Endocrinol. 2013 Jul 11;11:60. doi: 10.1186/1477-7827-11-60. — View Citation

La Marca A, Giulini S, Orvieto R, De Leo V, Volpe A. Anti-Müllerian hormone concentrations in maternal serum during pregnancy. Hum Reprod. 2005 Jun;20(6):1569-72. Epub 2005 Feb 25. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Anti Mullerian hormone (AMH) levels ng/mL at 8 weeks	AMH levels	Baseline and 8 weeks following surgery	No