- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02377128
Ovarian Reserve Following Bilateral Salpingectomy Versus Tubal Ligation During Cesarean Section
April 28, 2016 updated by: Hadas Ganer Herman, Wolfson Medical Center
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
45
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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undergoing elective cesrean section at the investigators' institution, requesting sterilization, willing to have blood withdrawn for AMH levels prior to surgery, willing to participate in 8 weeks post-operation follow up with blood withdrawn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- Non-elective cesarean section, non willing to have blood withdrawn or participate in follow up, prior salpingectomy, prior premature ovarian failure/egg donation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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bilateral salpingectomy
Cesarean section with bilateral salpingectomy
|
Surgical bilateral removal of fallopian tubes (not involving ovaries)
|
Active Comparator: Tubal ligation
Cesarean section with tubal ligation
|
Bilateral ligation of fallopian tubes (not involving ovaries)
|
No Intervention: No intervention
Cesarean section with no additional intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in Anti Mullerian hormone (AMH) levels ng/mL at 8 weeks
Time Frame: Baseline and 8 weeks following surgery
|
AMH levels
|
Baseline and 8 weeks following surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
February 15, 2015
First Submitted That Met QC Criteria
March 2, 2015
First Posted (Estimate)
March 3, 2015
Study Record Updates
Last Update Posted (Estimate)
April 29, 2016
Last Update Submitted That Met QC Criteria
April 28, 2016
Last Verified
April 1, 2016
More Information
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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Clinical Trials on Bilateral salpingectomy
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