| CTRI Number |
CTRI/2025/06/089000 [Registered on: 17/06/2025] Trial Registered Prospectively |
| Last Modified On: |
25/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Finding the best Letrozole regimen for PCOS related infertility |
|
Scientific Title of Study
|
Optimal dose and duration of Letrozole for ovulation induction in infertile women with Polycystic Ovarian Syndrome : A Randomised Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Archana Kumari |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Delhi |
| Address |
Room no 727, MCH BLOCK, Department of Obs and Gynae,
AIIMS ,New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9868308594 |
| Fax |
|
| Email |
drarchanaaiims0312@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vatsala Raje Rao |
| Designation |
Junior Resident (Academic) |
| Affiliation |
All India Institute of Medical Sciences, Delhi |
| Address |
House number 1311
Sector 46
Gurugram
Haryana
Gurgaon
HARYANA
122003
India |
| Phone |
8882965550 |
| Fax |
|
| Email |
vatsalarajerao6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Archana Kumari |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Delhi |
| Address |
Room no 727, MCH BLOCK, Department of Obs and Gynae,
AIIMS ,New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9868308594 |
| Fax |
|
| Email |
drarchanaaiims0312@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences,New Delhi
PIN code-110029
Country-India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences,New Delhi |
| Address |
All India Institute of Medical Sciences,
Ansari Nagar, New Delhi 110608 |
| 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 Vatsala Raje Rao |
All India Institute of Medical Sciences, Delhi |
Room number 727,7th floor
Department of Obstetrics and Gynaecology
Mother and Child Block
All India Institute of Medical Sciences (AIIMS)
Ansari Nagar
New Delhi – 110029 (India)
New Delhi
DELHI |
8882965550
vatsalarajerao6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Post Graduate Research, AIIMS Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E282||Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
T.Letrozole 2.5 mg OD for 10 days |
Group 2 (Case Group A): Low-dose, long-duration Letrozole—2.5 mg for 10 days (Cycle Days 2-11). Ovulation is assessed after the first cycle of treatment. If ovulation occurs, patient continues the same regimen for a total of three cycles.If ovulation does not occur after the first cycle,patients are switched to the high-dose, long-duration regimen (5 mg for 10 days, Group 3 protocol). |
| Comparator Agent |
T.Letrozole 5 mg for 5 days |
Group 1 (Control): Standard Letrozole regimen—5 mg for 5 days (Cycle Days 2-6). Ovulation is assessed after the first cycle of treatment. If ovulation occurs, patient continues the same regimen for a total of three cycles. If ovulation does not occur after the first cycle, patients are switched to the high-dose, long-duration regimen (5 mg for 10 days, Group 3 protocol). |
| Intervention |
T.Letrozole 5 mg OD for 10 days |
Group 3 (Case Group B): High-dose, long-duration Letrozole—5 mg for 10 days (Cycle Days 2-11).Ovulation is assessed after the first cycle of treatment. If ovulation occurs, patient continues the same regimen for a total of three cycles. If ovulation does not occur after the first cycle, patients are given gonadotropin injections (HMG 75/150 IU IM). If gonadotropin therapy fails, patients are managed according to the hospital’s protocol, which may include laparoscopic ovarian drilling or IVF. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
38.00 Year(s) |
| Gender |
Female |
| Details |
1. Any patient from 21 to 38 years attending Gynecology OPD with features of PCOS as per Modified Rotterdam criteria, which includes at least two out of the following three features:
Oligo or anovulation (menstrual cycle length greater than 35 years)
Clinical and or ovarian biochemical evidence of hyperandrogenism (mFG score greater than eight; serum testosterone greater than or equal to 0.56 nanograms per milliliter). FNPO greater than or equal to 20 and ovarian volume greater than 10 cubic centimeters in transvaginal scan done on day two.
2. Normal husband semen parameters as per the sixth edition WHO semen analysis 2021 criteria.
3. Patient with at least one tube patent as confirmed by hysterosalpingography. |
|
| ExclusionCriteria |
| Details |
1. Patients younger than 21 years and older than 38 years.
2. Patient with a history of endometriosis.
3. Patient with diminished ovarian reserve (AMH less than 1.5 nanograms per milliliter, AFC less than seven, FSH greater than 10 international units per milliliter).
4. Patient with uncontrolled thyroid disorders.
5. Patient with abnormal prolactin levels.
6. Patient with prior ovarian surgery.
7. Patient who has used any hormonal contraception or insulin sensitizers in the last three months. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Successful ovulatory response as determined by disappearance of dominant follicle on USG |
To assess response, follicular phase ultrasound will be performed
on day 11 of the cycle. Follicular monitoring will continue every
alternate day till a Dominant follicle of size more than 16 mm is formed.
Timed intercourse will be advised.
Response to treatment implies disappearance of at least one
dominant follicle more than 16 mm diameter or appearance of corpus luteal
cyst |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Number of different sizes of dominant follicles developed in each group.
2. Time to ovulation.
3.Maximum follicle size before rupture.
4. Endometrial thickness at the time of ovulation.
5.Need for Injection Gonadotropin.
6.Ovarian hyperstimulation syndrome rate (OHSS).
7.Clinical pregnancy rate.
8. Rate of multiple pregnancies.
9.Cycle cancellation rate.
10. Abortion rate.
11.Side effects like nausea, vomiting & any other drug reactions. |
1.On each follicular scan(Day 11 till ovulation)
2.From start of treatment to ovulation,per cycle
3.On last scan before rupture/ovulation
4.On last scan before follicle rupture
5.Recorded per cycle if given for ovulation trigger
6.Upto 2 weeks post-ovulation
7.UPT test if missed periods after 2 weeks
8.On early pregnancy USG (6–10 weeks gestation)
9.Documented per cycle due to non-response or complications
10.Recorded through first trimester follow-up
11.Monitored throughout each treatment cycle |
|
|
Target Sample Size
|
Total Sample Size="177"
Sample Size from India="177"
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)
|
10/05/2026 |
| 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)
|
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [vatsalarajerao6@gmail.com].
- For how long will this data be available start date provided 15-07-2027 and end date provided 15-06-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Thesis Protocol Summary
Title: Optimal Dose and Duration of Letrozole for Ovulation Induction in Infertile Women with PCOS
Study Design
A prospective interventional study comparing three different Letrozole regimens for ovulation induction in women with polycystic ovary syndrome (PCOS).
Study Groups
1. Group 1 (Control): Letrozole 5 mg for 5 days (Day 2-6)
2. Group 2 (Case A): Letrozole 2.5 mg for 10 days (Day 2-11)
3. Group 3 (Case B): Letrozole 5 mg for 10 days (Day 2-11)
Treatment Protocol
Maximum 3 cycles of Letrozole treatment.
If no ovulation after 1 cycle, dose modification will be done.
If ovulation is not achieved after 3 cycles, the patient will be switched to gonadotropin injections (HMG 75/150 IU IM).
If still unresponsive, management will follow hospital protocol (e.g., laparoscopic ovarian drilling or IVF).
Inclusion Criteria
Women aged 21-38 years with PCOS diagnosed by Modified Rotterdam Criteria (at least 2 out of 3):
Oligo/anovulation (cycle length >35 days)
Clinical/biochemical hyperandrogenism (mFG score >8, serum testosterone ≥0.56 ng/ml)
Polycystic ovaries on ultrasound (FNPO ≥20, ovarian volume >10 cc)
Normal husband semen parameters (as per WHO 2021 criteria).
At least one patent fallopian tube confirmed by hysterosalpingography.
Exclusion Criteria
Age <21 or >38 years
Endometriosis or prior ovarian surgery
Diminished ovarian reserve (AMH <1.5 ng/ml, AFC <7, FSH >10 IU/ml)
Uncontrolled thyroid disorders or abnormal prolactin levels
Use of hormonal contraception or insulin sensitizers in the past 3 months
The cost of Letrozole is covered by the institution. 2 ml blood will be taken for baseline investigations.
This study aims to determine the most effective Letrozole regimen for ovulation induction in PCOS patients, optimizing both dose and duration to improve pregnancy outcomes. |