VnotesNCT07177144
Does Vnotes Salpingectomy Reduce Ovarian Reserve?
A study testing anti müllerian hormone and anti müllerian hormon in people with Vnotes and Salpingectomy, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Vnotes, Salpingectomy, Ovarian Reserve
- What is being tested?
- anti müllerian hormone and anti müllerian hormon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jun 2025to 17 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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,
Who cannot join
- not being in the specified age range (18-45), having a history of tubal ligation, having tubal cancer
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpaşa Education and Research Hospital
Istanbul
About this study
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
Read the detailed description
The study will include participants who apply to our clinic for salpingectomy for contraception and agree to participate in the study. vnotes salpingectomy method or classical laparoscopic salpingectomy will be offered to the patients as two salpingectomy methods and the patient will be included in whichever group in the study. All surgeries will be performed by the same surgeon. 3 months after the date of surgery, the patient will be called for a follow-up for amh repeat and the two groups will be compared both within themselves and with each other to evaluate whether the different surgical technique has an effect on ovarian reserve.
- Conditions
- Vnotes, Salpingectomy, Ovarian Reserve
- Being tested
- anti müllerian hormone, anti müllerian hormon
- Keywords
- vnotes, salpingectomy, ovarian reserve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti müllerian hormoneOther
participants were checked for amh levels preoperatively
anti müllerian hormonDiagnostic test
participants were checked for amh levels at 3 months postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: anti müllerian hormone; Diagnostic 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 Receives: Other: anti müllerian hormone; Diagnostic Test: anti müllerian hormon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
To compare the success of the two surgical techniques Surgery duration: the time from when the patient first receives anesthesia until they are awakened, recorded in minutes (min)
Measured: Perioperative
Postoperative hospital stay duration
The days the patient stays in the hospital, starting from the first day they are admitted for surgery until they are discharged after full recovery following the surgery, will be recorded as days. the number of days the patient stays in the hospital, recorded in days (days)
Measured: Perioperative
postoperative pain
The patient is asked to rate the pain they feel from the moment they wake up after surgery on a scale of 1 to 10.
Measured: first hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start19 Jun 2025
- Primary completion17 Nov 2025
- Study completion17 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for VnotesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Elif Yıldız, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07177144
- Sponsor's protocol ID
- Gaziosmanpasatrehmh
- Status last verified
- Nov 2025
- First submitted
- 18 Aug 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 34411729Yildiz E, Coskun ES, Timur GY, Bacak HB, Aciyiyen Y, Terkan H, Bilici SR, Ersoy D, Aldanmaz B, Salman S, Celikoglu E. When Performing vNOTES Salpingectomy, Are We Damaging the Ovarian Reserve? Results From a Randomized, Controlled Trial. J Minim Invasive Gynecol. 2026 Jul;33(7):994-1000. doi: 10.1016/j.jmig.2026.02.009. Epub 2026 Feb 7.
PubMed 41662907
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Vnotes Salpingectomy Reduce Ovarian Reserve?
- ClinicalTrials.gov ID
- NCT07177144
- Acronym / sponsor ID
- Gaziosmanpasatrehmh
- Conditions
- Vnotes, Salpingectomy, Ovarian Reserve
- Keywords
- vnotes, salpingectomy, ovarian reserve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 19 Jun 2025 (actual)
- Primary completion
- 17 Nov 2025 (actual)
- Study completion
- 17 Nov 2025 (actual)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The study will include participants who apply to our clinic for salpingectomy for contraception and agree to participate in the study. vnotes salpingectomy method or classical laparoscopic salpingectomy will be offered to the patients as two salpingectomy methods and the patient will be included in whichever group in the study. All surgeries will be performed by the same surgeon. 3 months after the date of surgery, the patient will be called for a follow-up for amh repeat and the two groups will be compared both within themselves and with each other to evaluate whether the different surgical technique has an effect on ovarian reserve.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vnotes salpingectomy performed | Experimental | Other: anti müllerian hormone, Diagnostic Test: anti müllerian hormongroup of women who underwent salpingectomy with the vnotes method for women who wanted to have their tubes removed for contraception |
| laparoscopic salpingectomy performed | Active comparator | Other: anti müllerian hormone, Diagnostic Test: anti müllerian hormongroup of women who underwent salpingectomy with the laparoscopic salpingectomy method for women who wanted to have their tubes removed for contraception |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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,
Key exclusion criteria (1 listed)
- not being in the specified age range (18-45), having a history of tubal ligation, having tubal cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anti müllerian hormoneparticipants were checked for amh levels preoperatively | Other | laparoscopic salpingectomy performed, vnotes salpingectomy performed |
| anti müllerian hormonparticipants were checked for amh levels at 3 months postoperatively. | Diagnostic test | laparoscopic salpingectomy performed, vnotes salpingectomy performed |
Primary outcome
measuring anti-millerian hormone level
Time frame: amh level (ng/ml) will be checked before the operation, and after 3 months, she will be called for control and measured again.
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.
3 secondary outcomes
comparison of duration of surgery
Time frame: Perioperative
Postoperative hospital stay duration
Time frame: Perioperative
postoperative pain
Time frame: first hour after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Results publication: PubMed 34411729Yassa 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.
- Derived from this study: PubMed 41662907Yildiz E, Coskun ES, Timur GY, Bacak HB, Aciyiyen Y, Terkan H, Bilici SR, Ersoy D, Aldanmaz B, Salman S, Celikoglu E. When Performing vNOTES Salpingectomy, Are We Damaging the Ovarian Reserve? Results From a Randomized, Controlled Trial. J Minim Invasive Gynecol. 2026 Jul;33(7):994-1000. doi: 10.1016/j.jmig.2026.02.009. Epub 2026 Feb 7.
- Individual participant dataSharing planned: No. 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.
Related trials for Vnotes
Not yet recruitingObservational study
Effects of Trendelenburg Position and Pneumoperitoneum on Mechanical Power and Respiratory Mechanics During V-NOTES Surgery
Vnotes, Respiratory Mechanics
RecruitingObservational study
Ultrasound Evaluation for Improving Patient Selection in vNOTES
Surgery
Recruiting
vNOTES Versus Vaginal Hysterectomy for Benign Gynecologic Indications
Hysterectomy, Benign Uterine Diseases
Recruiting
Deep Neuromuscular Blockade and a Low-Residue Diet for the Surgical Field in vNOTES Hysterectomy
Leiomyoma, Uterine, Benign Gynecological Disease
Not yet recruitingObservational study
vNOTES vs Laparoscopy: Respiratory Mechanics and Hemodynamics
Respiratory Mechanics, Hemodynamics
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anti müllerian hormone and anti müllerian hormon in people with Vnotes and Salpingectomy, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measuring anti-millerian hormone level (time frame: amh level (ng/ml) will be checked before the operation, and after 3 months, she will be called for control and measured again.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07177144, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.