| CTRI Number |
CTRI/2026/01/101536 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
17/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Preventive |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
This study looks at whether removing the fallopian tubes affects how well the ovaries continue to work in patients planned for another surgery mainly hysterectomy and their effect on hormones released by the ovaries |
|
Scientific Title of Study
|
Effect of opportunistic salpingectomy on ovarian reserve A quasi experimental study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vigya Baghel |
| Designation |
First year Post graduate resident |
| Affiliation |
Uttar Pradesh university of medical sciences |
| Address |
Department of obstetrics and gynaecology, Uttar Pradesh University of Medical Sciences(UPUMS), Saifai
Etawah
UTTAR PRADESH
206130
India |
| Phone |
8076972827 |
| Fax |
|
| Email |
vigyawrites@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Soniya Vishwakarma |
| Designation |
Professor junior grade |
| Affiliation |
Uttar Pradesh university of medical sciences |
| Address |
Department of obstetrics and Gynaecology, Uttar Pradesh University of Medical Sciences(UPUMS), Saifai
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7500271576 |
| Fax |
|
| Email |
soniyaramesh17@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soniya Vishwakarma |
| Designation |
Professor junior grade |
| Affiliation |
Uttar Pradesh university of medical sciences |
| Address |
Department of obstetrics and Gynaecology, Uttar Pradesh University of Medical Sciences(UPUMS), Saifai
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7500271576 |
| Fax |
|
| Email |
soniyaramesh17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttar Pradesh University of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Uttar Pradesh university of medical sciences |
| Address |
Saifai, Etawah, Uttar Pradesh, India
Pin Code: 206130 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vigya Baghel |
UPUMS (Uttar Pradesh university of medical sciences) |
OPD Number 10, Department of Obstetrics and Gynaecology, Saifai Etawah
Etawah
UTTAR PRADESH |
8076972827
vigyawrites@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: N859||Noninflammatory disorder of uterus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Opportunistic salpingectomy |
In patients undergoing hysterectomy for benign causes, opportunistic salpingectomy ie bilateral fallopian tubes will be removed and their effect on ovarian reserve will be studied in terms of Serum follicle stimulating hormone leutinizing hormone and anti mullerian hormone. Their levels will be measured and compared pre and post opertiavely in hysterectomy patients. This will be done for a time period of 18 months. |
| Comparator Agent |
Patients who are not undergoing opportunistic salpingectomy for benign causes |
patients who fall into the exclusion criteria |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Premenopausal women with regular menstrual cycles that are undergoing opportunistic salpingectomy for benign reasons with normal baseline ovarian reserve and are willing to participate in the trial |
|
| ExclusionCriteria |
| Details |
Patients that have undergone any ovarian, tubal or gynecological surgery or presence of any gynaecological pathology like PCOS malignancy or endometrioma. Women who are on hormonal pills for the past 3 months or who have known infertility. Post menopausal women and women who have underwent hysterectomy with unilateral or bilateral oopherectomy or salpingo oopherectomy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The vascular supply to the ovaries is largely preserved when salpingectomy is performed carefully. Hence, no early menopause or hormonal dysfunction has been. Helps reduce the cancer burden.It is a cost-neutral or low-cost addition to routine surgeries.
|
FSH, LH and AMH will be measured at baseline level and then after salpingectomy and after 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="115"
Sample Size from India="115"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
28/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Opportunistic
salpingectomy, the surgical removal of both non diseased fallopian tubes,
performed for various benign gynaecological indications such as fibroid uterus,
adenomyosis and as tubal sterilization, and as a prophylactic procedure in
women at average risk for ovarian or tubal cancers. While this procedure is generally considered safe and
effective, growing attention is being directed toward its potential impact on
ovarian function. The ovaries and fallopian
tubes share a close anatomical and vascular relationship. The concern that
salpingectomy might compromise ovarian blood supply and thus impair ovarian
function has prompted several studies.
Ovarian dysfunction, often characterized by
altered hormone levels, decreased ovarian reserve, and changes in menstrual
regularity, can have significant implications for a woman’s reproductive and
overall health. This thesis aims to
investigate the effects of opportunistic salpingectomy on ovarian function,
examining hormonal profiles, ovarian reserve markers such as anti-Müllerian
hormone (AMH) and clinical outcomes related to ovarian reserve and menopause
onset.
Understanding whether salpingectomy adversely
affects ovarian health is essential in guiding clinical decisions, especially
in women of reproductive age or those at risk of early ovarian insufficiency.
Through a comprehensive
analysis of available clinical data and comparison with non-salpingectomy
controls, this study seeks to clarify whether opportunistic salpingectomy poses
a risk to ovarian function, and under what circumstances such risks might be
mitigated. |