NCT02377128

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2015

Completed
14 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

April 29, 2016

Status Verified

April 1, 2016

Enrollment Period

1.8 years

First QC Date

February 15, 2015

Last Update Submit

April 28, 2016

Conditions

Ovarian Reserve

Keywords

Studyfocusovarianreserve

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Anti Mullerian hormone (AMH) levels ng/mL at 8 weeks

    AMH levels

    Baseline and 8 weeks following surgery

Study Arms (3)

Bilateral salpingectomy

EXPERIMENTAL

Cesarean section with bilateral salpingectomy

Procedure: Bilateral salpingectomy

Tubal ligation

ACTIVE COMPARATOR

Cesarean section with tubal ligation

Procedure: Tubal ligation

No intervention

NO INTERVENTION

Cesarean section with no additional intervention

Interventions

Bilateral salpingectomyPROCEDURE

Surgical bilateral removal of fallopian tubes (not involving ovaries)

Bilateral salpingectomy
Tubal ligationPROCEDURE

Bilateral ligation of fallopian tubes (not involving ovaries)

Tubal ligation

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Non-elective cesarean section, non willing to have blood withdrawn or participate in follow up, prior salpingectomy, prior premature ovarian failure/egg donation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (14)

  • 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.

    PMID: 24412119BACKGROUND

  • 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.

    PMID: 23583217BACKGROUND

  • 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.

    PMID: 23880597BACKGROUND

  • 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.

    PMID: 8922304BACKGROUND

  • Falconer H, Yin L, Gronberg H, Altman D. Ovarian cancer risk after salpingectomy: a nationwide population-based study. J Natl Cancer Inst. 2015 Jan 27;107(2):dju410. doi: 10.1093/jnci/dju410. Print 2015 Feb.

    PMID: 25628372BACKGROUND

  • 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.

    PMID: 25560145BACKGROUND

  • 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.

    PMID: 19250369BACKGROUND

  • 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. doi: 10.1111/j.1447-0756.2007.00669.x.

    PMID: 18001455BACKGROUND

  • 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.

    PMID: 23558052BACKGROUND

  • 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.

    PMID: 23993887BACKGROUND

  • 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. doi: 10.1056/NEJM199703133361104.

    PMID: 9052654BACKGROUND

  • Koninger 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.

    PMID: 23844593RESULT

  • La Marca A, Giulini S, Orvieto R, De Leo V, Volpe A. Anti-Mullerian hormone concentrations in maternal serum during pregnancy. Hum Reprod. 2005 Jun;20(6):1569-72. doi: 10.1093/humrep/deh819. Epub 2005 Feb 25.

    PMID: 15734752RESULT

  • Ganer Herman H, Gluck O, Keidar R, Kerner R, Kovo M, Levran D, Bar J, Sagiv R. Ovarian reserve following cesarean section with salpingectomy vs tubal ligation: a randomized trial. Am J Obstet Gynecol. 2017 Oct;217(4):472.e1-472.e6. doi: 10.1016/j.ajog.2017.04.028. Epub 2017 Apr 25.

    PMID: 28455082DERIVED

MeSH Terms

Interventions

Sterilization, Tubal

Intervention Hierarchy (Ancestors)

Gynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, OperativeSterilization, Reproductive

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

February 15, 2015

First Posted

March 3, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2016

Last Updated

April 29, 2016

Record last verified: 2016-04