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CTRI Number  CTRI/2023/10/059166 [Registered on: 26/10/2023] Trial Registered Prospectively
Last Modified On: 15/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   study to assess efficacy of extended regimen of letrozole in infertile women with polycystic ovarian syndrome 
Scientific Title of Study   Efficacy of extended regimen of letrozole in infertile women with polycystic ovarian syndrome: a randomized 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  Bhavneet Kaur 
Designation  Junior Resident 
Affiliation  AIIMS NEW DELHI 
Address  Department of Obstetrics and Gynaecology, AIIMS, Ansari Nagar East, New Delhi

South
DELHI
110029
India 
Phone  9888704201  
Fax    
Email  bhavneetkaur201@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Archana Kumari 
Designation  Assistant Professor 
Affiliation  AIIMS NEW DELHI 
Address  Department of Obstetrics and Gynaecology, AIIMS, Ansari Nagar East, New Delhi

South
DELHI
110029
India 
Phone  9888704201  
Fax    
Email  drarchanaaiims0312@gmail.com  
 
Details of Contact Person
Public Query  
Name  Bhavneet Kaur 
Designation  Junior Resident 
Affiliation  AIIMS NEW DELHI 
Address  Department of Obstetrics and Gynaecology, AIIMS, Ansari Nagar East, New Delhi

South
DELHI
110029
India 
Phone  9888704201  
Fax    
Email  bhavneetkaur201@gmail.com  
 
Source of Monetary or Material Support  
AIIMS, Ansari Nagar East, New Delhi 
 
Primary Sponsor  
Name  AIIMS NEW DELHI 
Address  Department of Obstetrics and Gynaecology, AIIMS, Ansari Nagar East, NEW DELHI 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Bhavneet Kaur  AIIMS NEW DELHI  DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY
South
DELHI 		 9888704201

bhavneetkaur201@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS NEW DELHI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N970||Female infertility associated withanovulation, (2) ICD-10 Condition: E282||Polycystic ovarian syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Letrozole extended regimen for ovulation induction  Tablet letrozole (Aromatase inhibitor) 2.5 mg once daily per oral for 10 days given from day 2-11 of menstrual cycle for ovulation induction in infertile women with polycystic ovarian syndrome upto 3 ovulation induction cycles 
Comparator Agent  Letrozole standard regimen for ovulation induction  Tablet letrozole (Aromatase inhibitor) 2.5 mg once daily per oral for 5 days given from day 2-6 of menstrual cycle for ovulation induction in infertile women with polycystic ovarian syndrome upto 3 ovulation induction cycles 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  38.00 Year(s)
Gender  Female 
Details  Any patient from 21-38 years attending gynaecology OPD with features of PCOS as per modified Rotterdam criteria i.e. with 2/3 features: Oligo/anovulation, clinical and/or biochemical evidence of hyperandrogenism
Normal husband semen parameters as per sixth edition WHO semen analysis 2021 criteria.
Patient with at least one patent fallopian tube confirmed by hysterosalpingography or laparoscopy.
Patient with controlled thyroid disorders.
Patient with normal prolactin levels.
Patient with no ovarian surgery.
Patient who are not on any hormonal contraception or insulin sensitizers in last 3 months.

 
 
ExclusionCriteria 
Details  Patients less than 21 years and more than 38 years.
Patient with history of endometriosis.
Patient with diminished ovarian reserve (AMH <1.5 ng/ml, AFC<7, FSH>10 IU/ml).
Patient with uncontrolled thyroid disorder.
Patient with hyperprolactinemia.
Patient with non-classical congenital adrenal hyperplasia.
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Development of at least one follicle 16mm diameter with ovulation induction cycle by extended letrozole regimen as well as the standard regimen   18 days  
 
Secondary Outcome  
Outcome  TimePoints 
Number of different sizes of dominant follicles developed in each group.
To correlate S.AMH levels with follicular response in both groups.
Need for Injection Gonadotropin.
Ovarian hyperstimulation syndrome rate (OHSS).
Clinical pregnancy rate.
Cycle cancellation rate.
Abortion rate.
 		 3 ovulation induction cycles 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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 2/ Phase 3 
Date of First Enrollment (India)   26/10/2023 
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 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   Polycystic ovary syndrome (PCOS) is a complex condition in women associated with psychological, reproductive and metabolic features. PCOS is the most common hormonal disorder in women and accounts for ~80% of women with anovulatory infertility. A large subset of patients with chronic anovulation are unable to conceive and seek treatment for infertility. Ovulation induction therapy is the treatment of choice for such patients. Letrozole, a highly selective aromatase inhibitor (AI), has been found to be effective in inducing ovulation in anovulatory and ovulatory infertile women with inadequate response to clomiphene citrate (CC). Letrozole is typically prescribed at a starting dose of 2.5 mg or 5 mg daily for 5 days. Women with PCOS who do not ovulate or become pregnant with letrozole may be candidates for therapy with injectable gonadotropins. Advantages of AIs include that they can be orally administered with almost 100% bioavailability, have rapid clearance from the body (short half-life, ≈45 hours), well tolerated on daily administration and have no adverse effect on endometrium or cervical mucus. Moreover, the disadvantages of gonadotropins are injectable preparation, thus uncomfortable for the patient, require a health professional and multiple hospital visits for administration, have higher costs for ovulation induction along with increased risk of OHSS. Extending the duration of letrozole treatment in the mid follicular phase would maintain FSH levels above the threshold allowing multi follicular development and larger size dominant and mature follicles. Looking at the advantages and the mechanism by which letrozole works in ovulation induction, letrozole alone treatment has been tried with different doses. However there has been very few studies assessing the optimum duration of letrozole therapy. Thus the purpose of this study is to assess the response of extended letrozole regimen compared to standard letrozole regimen in infertile women with PCOS undergoing ovulation induction.

AIM: To assess the response to extended regimen of letrozole in comparison to standard letrozole regimen in infertile women with PCOS undergoing ovulation induction.

HYPOTHESIS: Extended letrozole therapy might result in better ovulatory response than standard letrozole therapy in infertile women with PCOS. 
 
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