| CTRI Number |
CTRI/2018/05/014274 [Registered on: 31/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
31/12/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
HSG, Hysteroscopic and laparoscopic findings in women wanting to conceive |
|
Scientific Title of Study
|
comparative study of hysterosalpingography and hysterolaparoscopy in infertile women |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Leena Wadhwa |
| Designation |
Associate Professor |
| Affiliation |
Employee State Insurance-Post graduate institute of medical and research,Basaidarapur,Delhi |
| Address |
Academic block,ESI-PGIMSR,Basaidarapur,Delhi
West
DELHI
110015
India
Academic block,ESI-PGIMSR,Basaidarapur,Delhi
West
DELHI
110015
India
New Delhi
DELHI
110015
India |
| Phone |
9910933447 |
| Fax |
|
| Email |
drleena_123@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja Rani |
| Designation |
Post Graduate Student |
| Affiliation |
Employee State Insurance-Post graduate institute of medical and research,Basaidarapur,Delhi |
| Address |
Academic block,ESI-PGIMSR,Basaidarapur,Delhi
West
DELHI
110015
Academic block,ESI-PGIMSR,Basaidarapur,Delhi
West
DELHI
110015
New Delhi
DELHI
110015
India |
| Phone |
07838257265 |
| Fax |
|
| Email |
worship.pooja65@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Leena Wadhwa |
| Designation |
Associate Profesor |
| Affiliation |
Employee State Insurance-Post graduate institute of medical and research,Basaidarapur,Delhi |
| Address |
Academic block,ESI-PGIMSR,Basaidarapur,Delhi
West
DELHI
110015
Academic block,ESI-PGIMSR,Basaidarapur,Delhi
West
DELHI
110015
New Delhi
DELHI
110015
India |
| Phone |
09910933447 |
| Fax |
|
| Email |
drleena_123@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| ESI PGIMSR Basaidarapur New Delhi |
|
|
Primary Sponsor
|
| Name |
Employee state insurance post graduate institute of medicine and researchBASAIDARAPUR |
| Address |
ESI-PGIMSR,BASAIDARAPUR,DELHI |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Leena Wadhwa |
Department of Obstetrics and Gynaecology, Infertility clinic |
Academic Block,ESI-PGIMSR Basaidarapur, Delhi west
New Delhi
DELHI |
09910933447
drleena_123@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Infertility, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
single arm trial in which HSG followed by hysterolaparoscopy will be done and then compared |
| Intervention |
single arm trial in which HSG findings are compared with hysterolaparoscopy |
the findings and complications of HSG and hysterolaparoscopy will be compared in infertile women |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. All women attending infertility clinic for treatment (primary and secondary)
2. Age 20-40 years
3. No prior pelvic surgery
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria
1. Known pelvic inflammatory disease
2. Women with acute vaginal and cervical infection
3. Women allergic to dye used in hysterosalpingography
4. Cardiac and respiratory diseases contraindicating CO2 pneumoperitoneum
5. Diaphragmatic and umbilical hernia
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of diagnostic value of hysterolaparoscopy with hysterosalpingography in infertile women |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| complications of hysterolaparoscopy as compared to hysterosalpingography in infertile women |
3 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
23/10/2013 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Present study is an observational comparative study conducted to compare the diagnostic value of hysterosalpingography with hysterolaparoscopy in infertile women. Women attending infertility clinic with primary or secondary infertility , who fulfill the inclusion criteria , are enrolled in the study. After performing basic infertility work up, Hysterosalpingography and Hysterolaparoscopy will be performed on each women included in study. The findings and complications of both the procedures will be compared. The diagnostic value of both the procedures in identifying the cause of infertility will be evaluated and compared.
Primary outcome
Comparison of diagnostic value of hysterosalpingography with hysterolaparoscopy
Secondary outcome
Comparison of complications of hysterolaparoscopy as compare to hysterosalpingography
|