NCT07177144

Brief Summary

Comparison of Transvaginal Natural Orifice Transluminal Endoscopic Surgery and Conventional Laparoscopy in terms of their effects on ovarian reserve in Opportunistic Bilateral Salpingectomy for Permanent Female Sterilization

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 19, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

September 16, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2025

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

5 months

First QC Date

August 18, 2025

Last Update Submit

November 17, 2025

Conditions

Keywords

vnotessalpingectomyovarian reserve

Outcome Measures

Primary Outcomes (1)

  • measuring anti-millerian hormone level

    To evaluate the effect of two surgical methods on ovarian reserve by measuring serum anti-Müllerian hormone levels (ng/ml) before surgery and after salpingectomy.

    amh level (ng/ml) will be checked before the operation, and after 3 months, she will be called for control and measured again.

Secondary Outcomes (3)

  • comparison of duration of surgery

    Perioperative

  • Postoperative hospital stay duration

    Perioperative

  • postoperative pain

    first hour after surgery

Study Arms (2)

vnotes salpingectomy performed

EXPERIMENTAL

group of women who underwent salpingectomy with the vnotes method for women who wanted to have their tubes removed for contraception

Other: anti müllerian hormoneDiagnostic Test: anti müllerian hormon

laparoscopic salpingectomy performed

ACTIVE COMPARATOR

group of women who underwent salpingectomy with the laparoscopic salpingectomy method for women who wanted to have their tubes removed for contraception

Other: anti müllerian hormoneDiagnostic Test: anti müllerian hormon

Interventions

participants were checked for amh levels preoperatively

laparoscopic salpingectomy performedvnotes salpingectomy performed
anti müllerian hormonDIAGNOSTIC_TEST

participants were checked for amh levels at 3 months postoperatively.

laparoscopic salpingectomy performedvnotes salpingectomy performed

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • to want to have your tubes removed, not to have undergone tubal and ovarian surgery before, not to use hormones and medications that can affect the level of sex hormones and its levels,

You may not qualify if:

  • not being in the specified age range (18-45), having a history of tubal ligation, having tubal cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpaşa Education and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Yassa M, Kaya C, Kalafat E, Tekin AB, Karakas S, Mutlu MA, Birol P, Tug N. The Comparison of Transvaginal Natural Orifice Transluminal Endoscopic Surgery and Conventional Laparoscopy in Opportunistic Bilateral Salpingectomy for Permanent Female Sterilization. J Minim Invasive Gynecol. 2022 Feb;29(2):257-264.e1. doi: 10.1016/j.jmig.2021.08.009. Epub 2021 Aug 16.

MeSH Terms

Interventions

Anti-Mullerian Hormone

Intervention Hierarchy (Ancestors)

Testicular HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor of gynecology and obstetrics

Study Record Dates

First Submitted

August 18, 2025

First Posted

September 16, 2025

Study Start

June 19, 2025

Primary Completion

November 17, 2025

Study Completion

November 17, 2025

Last Updated

November 19, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

The name, surname and personal data of the patients will never be shared with anyone. Data related to the study such as surgical information, amh level, antral follicle count, etc. specified in the informed consent obtained for the study will be used.

Locations