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CTRI Number  CTRI/2020/06/025688 [Registered on: 08/06/2020] Trial Registered Prospectively
Last Modified On: 02/11/2022
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 for Anovulatory Infertility in female with PCOS 
Scientific Title of Study   Combination of Letrozole and Clomiphene Citrate Versus Letrozole alone for ovulation induction in women with polycystic ovary 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  Dr Anupama Bahadur 
Designation  Additional Professor 
Affiliation  All India Institute Of Medical Sciences, Rishikesh 
Address  Department of obstetrics and Gynaecology, AIIMS, Rishikesh, Dehradun,Uttarakhand India, 249201

Dehradun
UTTARANCHAL
249201
India 
Phone  9810326959  
Fax    
Email  anupama.bahadur@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anupama Bahadur 
Designation  Additional Professor 
Affiliation  All India Institute Of Medical Sciences, Rishikesh 
Address  Department of obstetrics and Gynaecology, AIIMS, Rishikesh, Dehradun,Uttarakhand India, 249201

Dehradun
UTTARANCHAL
249201
India 
Phone  9810326959  
Fax    
Email  anupama.bahadur@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anupama Bahadur 
Designation  Additional Professor 
Affiliation  All India Institute Of Medical Sciences, Rishikesh 
Address  Department of obstetrics and Gynaecology, AIIMS, Rishikesh, Dehradun,Uttarakhand India, 249201

Dehradun
UTTARANCHAL
249201
India 
Phone  9810326959  
Fax    
Email  anupama.bahadur@gmail.com  
 
Source of Monetary or Material Support  
Dr Anupama Bahadur Additional Professor Department of Obstetrics and Gynaecology AIIMS,Rishikesh, Dehradun,Uttarakhand,India. 
 
Primary Sponsor  
Name  Dr Anupama Bahadur 
Address  Department of Obstetrics and Gynaecology,AIIMS, Rishikesh, Dehradun, Uttarakhand. 
Type of Sponsor  Other [Dr Anupama Bahadur] 
 
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 
Dr Swetha Sri  Department of Obstetrics and Gynaecology, All India Institute Of Medical Sciences, Rishikesh  3rd floor,Block C,OBG department, AIIMA,Rishikes,Dehradun, Uttarakhand,India.
Dehradun
UTTARANCHAL 		 8143409172

swethasri62@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS,RISHIKESH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E282||Polycystic ovarian syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Combination of Letrozole and Clomiphene Citrate Versus Letrozole alone for ovulation induction in women with polycystic ovary syndrome-a Randomized Controlled Trial  Letrozole 2.5 mg + Clomiphene Citrate 50 mg, once a day , orally, 5 days in a month starting on day 2 of menstrual cycle  
Comparator Agent  Combination of Letrozole and Clomiphene Citrate Versus Letrozole alone for ovulation induction in women with polycystic ovary syndrome-a Randomized Controlled Trial  Letrozole 2.5 mg, once a day , orally, 5 days in a month starting on day 2 of menstrual cycle  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  38.00 Year(s)
Gender  Female 
Details  1-Women 20–35 years of age with PCOS(according to Rotterdam criteria).
2-Primary / Secondary Infertile women with PCOS
3-BMI <30 kg/m2
4-Willing to participate in study and follow up
 
 
ExclusionCriteria 
Details  1-Pregnancy
2-Patient already on other drugs for treatment of PCOS like OCPs
3-Other known cause of infertility (Endometriosis, Unexplained Infertility, Moderate to severe male factor infertility)
4-Deranged kidney or liver function tests
5-Uncontrolled Thyroid disorders
6-Untreated hyperprolactinemia
7-Women with any other endocrinological disorders
8-Medical conditions not well controlled or not recommended during pregnancy (i.e., uncontrolled type 1 or 2 diabetes mellitus, hypertension, hypothyroidism)
9-Allergy or contraindications to letrozole or CC
10-Clinical suspicion of other etiologies that mimic PCOS warranting additional evaluation
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Total number of women attaining clinical pregnancy in either group (confirmed by USG)  18 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Ovulation rate
2. Number of OHSS(Ovarian Hyper-Stimulation Syndrome) cases
3. Number of abortions
4. Numberof ectopic or multiple pregnancies
 		 18 months 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
Final Enrollment numbers achieved (Total)= "68"
Final Enrollment numbers achieved (India)="68" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   10/06/2020 
Date of Study Completion (India) 31/12/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="1" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 In this trial we are giving Ovulation induction with Letrozole or letrozole+ clomiphene citrate  for anovulatory PCOS females with infertility and comparing the pregnancy rate in both groups. 
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