| CTRI Number |
CTRI/2025/08/092378 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
03/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Sexually transmitted infections among women seeking fertility care |
|
Scientific Title of Study
|
Sexually transmitted infections among female attendees of a fertility clinic |
| 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 Prakriti Chaudhuri |
| Designation |
Junior resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Microbiology, Maulana Azad Medical College, New Delhi, India
Central
DELHI
110002
India |
| Phone |
9073265102 |
| Fax |
|
| Email |
prakriti1506@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rohit Chawla |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Microbiology, Maulana Azad Medical College, New Delhi, India
Central
DELHI
110002
India |
| Phone |
9810079074 |
| Fax |
|
| Email |
rohitchawla75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rohit Chawla |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Microbiology, Maulana Azad Medical College, New Delhi, India
Central
DELHI
110002
India |
| Phone |
9810079074 |
| Fax |
|
| Email |
rohitchawla75@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and Lok Nayak Hospital, Delhi 110002, India |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Bahadur Shah Zafar Marg, Near Delhi Gate, Maulana Azad Medical College campus, Balmiki Basti, New Delhi 110002 |
| 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 Prakriti Chaudhuri |
Maulana Azad Medical College |
Department of Microbiology, Pathology block, Maulana Azad Medical College, Delhi 110002
Central
DELHI |
9073265102
prakriti1506@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z314||Encounter for procreative investigation and testing, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
The study will include first time adult female attendees of a fertility clinic. |
|
| ExclusionCriteria |
| Details |
The study will exclude patients who have received antibiotics in the past 15 days. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the frequency of various sexually transmitted pathogens among first time female attendees of the fertility clinic of Lok Nayak Hospital, New Delhi |
1 Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the association of various clinico-epidemiological factors associated with various sexually transmitted infections in these study subjects. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
18/08/2025 |
| 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="0"
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
|
The study entitled "Sexually transmitted infections among female attendees of a fertility clinic" will be conducted at the Department of Microbiology, Maulana Azad Medical College, in collaboration with the Department of Obstetrics and Gynaecology, Maulana Azad Medical College. Only after proper consent, urine and blood samples will be taken for multiplex PCR and serology testing respectively as part of the diagnosis. A semi structured questionnaire will be used for recording data regarding the clinico-epidemiological profile of the patients. |