| CTRI Number |
CTRI/2025/08/093334 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
15/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
Role of laparo-hysteroscopy (invasive technique to visualise female reproductive tract) in evaluating female factors in infertility |
|
Scientific Title of Study
|
Role of laparo-hysteroscopy in evaluating female factors in infertility |
| 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 Aditi Gaur |
| Designation |
First year postgraduate student |
| Affiliation |
Kasturba Hospital, Daryaganj , New Delhi |
| Address |
Department of Obstetrics and Gynaecology, Kasturba Hospital , Daryaganj , New Delhi
Central
DELHI
110002
India |
| Phone |
8076412789 |
| Fax |
|
| Email |
gauraditi98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivani Agarwal |
| Designation |
Senior specialist |
| Affiliation |
Kasturba Hospital , Daryaganj |
| Address |
Department of Obstetrics and Gynaecology, Kasturba Hospital, Daryaganj, New Delhi
Central
DELHI
110002
India |
| Phone |
9868249464 |
| Fax |
|
| Email |
dragarwal.shivani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivani Agarwal |
| Designation |
Senior specialist |
| Affiliation |
Kasturba Hospital , Daryaganj |
| Address |
Department of Obstetrics and Gynaecology, Kasturba Hospital, Daryaganj, New Delhi
Central
DELHI
110002
India |
| Phone |
9868249464 |
| Fax |
|
| Email |
dragarwal.shivani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Obstetrics and Gynaecology Kasturba Hospital Daryaganj New Delhi |
|
|
Primary Sponsor
|
| Name |
Dr Aditi Gaur |
| Address |
Kasturba Hospital Daryaganj |
| Type of Sponsor |
Other [Self] |
|
|
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 Aditi Gaur |
Kasturba Hospital |
Department of Obstetrics and Gynaecology
Central
DELHI |
8076412789
gauraditi98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Primary infertility
Secondary infertility
PCOS
Premature ovarian failure |
|
| ExclusionCriteria |
| Details |
Acute pelvic infections
Male factor infertility
Active TB infection
Not living together for 12 months
Contraindication to general anaesthesia
Anorexia
Hypothyroidism
Hyperprolactinemia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcomes of this study can be abnormal findings in laparoscopy or abnormal findings in hysteroscopy which affect the female reproductive system and result in infertility. They can be - any abnormal growth in uterine cavity (polyps, septum), blockage of fallopian tubes (obliterated ostium), adhesions in cavity, ovarian cysts, endometriosis. |
At baseline, when laparoscopy and hysteroscopy is done (same-setting procedure) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="49"
Sample Size from India="49"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
As the infertility rates are rising due to changing lifestyle, there is a need of more developed and more refined techniques to find out the root cause of infertility. Clinically, the majority of pelvic pathologies have been difficult to determine based on routine pelvic examinations alone. Laparohysteroscopy is a more advanced method which helps to diagnose the causes of infertility as it has ability to see and manipulate uterus, ovaries and fallopian tubes and it also offers a panoramic and magnified view of the organs. This study will be carried out to determine the different causes of female infertility and the role of laparohysteroscopy as a diagnostic and therapeutic tool for infertility. |