| CTRI Number |
CTRI/2025/07/090454 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
07/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ovulation induction in pcod patient by letrozle by comparing study |
|
Scientific Title of Study
|
Letrozole stair-step protocol
versus standard protocol of ovulation induction in
patients with polycystic ovarian syndrome. |
| 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 ARUNA VERMA |
| Designation |
PROFFESOR |
| Affiliation |
CHAUDHARY CHARAN SINGH UNIVERSITY |
| Address |
APARTMENT NO -38 NEAR SBI BANK LLRM MEDICAL COLLEGE
DEPARTMENT OF OBSTETRICS AND GYNECOLOGY
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9997706487 |
| Fax |
|
| Email |
ArunaVerma36@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
LAKSHMI KUMARI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
CHAUDHARY CHARAN SINGH UNIVERSITY |
| Address |
ROOM NO G -20 PG GIRLS HOSTEL LLRM MEDICAL COLLEGE DEPARTMENT OF OBSTETRICS AND GYNECOLOGY
Meerut
UTTAR PRADESH
250004
India |
| Phone |
7651850526 |
| Fax |
|
| Email |
lakshmikmri141@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
LAKSHMI KUMARI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
CHAUDHARY CHARAN SINGH UNIVERSITY |
| Address |
ROOM NO G- 20 PG GIRLS HOSTEL LLRM MEDICAL COLLEGE
DEPARTMENT OF OBSTETRICS AND GYNECOLOGY
Meerut
UTTAR PRADESH
250004
India |
| Phone |
7651850526 |
| Fax |
|
| Email |
lakshmikmri141@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
LAKSHMI KUMARI |
| Address |
ROOM NO G- 20 PG GIRLS HOSTEL LLRM MEDICAL COLLEGE
DEPARTMENT OF OBSTETRICS AND GYNECOLOGY |
| 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 |
| Lakshmi kumari |
LLRM MEDICAL COLLEGE |
PG girls hostel LLRM medical college meerut
Meerut
UTTAR PRADESH |
7651850526
lakshmikmri141@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Letrozole |
2.5-7.5 mg od 5 days |
| Intervention |
Letrozole |
2.5-7.5 mg od for 5 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
All women giving written and informed consent.
Women aged 21-40 years.
Diagnosis of PCOS based on the Rotterdam criteria.
History of anovulatory infertility
Normal uterine and tubal patency confirmed by hysterosalpingography or laparoscopy.
Normal semen analysis of partner according to WHO criteria |
|
| ExclusionCriteria |
| Details |
All women not giving written and informed consent.
History of hypersensitivity to letrozole or similar drugs
Liver or renal dysfunction
Endocrine disorders other than PCOS (e.g., thyroid disease, hyperprolactinemia)
Previous ovulation induction within the last 3 months
Current or past history of breast or endometrial cancer |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Ovulation induction
|
6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean time of ovulation
Pregnancy and live birth rate
Multiple pregnancy rate
|
1 year |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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 4 |
|
Date of First Enrollment (India)
|
25/07/2025 |
| 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 Yet Recruiting |
| 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 stair step protocol a modified approach to ovulation induction differs from standard protocol by eliminating need for a progestin withdrawal bleed between treatment cycle this allows for a faster identification of a effective dose and potentially quicker ovulation |