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CTRI Number  CTRI/2025/03/081960 [Registered on: 07/03/2025] Trial Registered Prospectively
Last Modified On: 19/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study the effects of gonadotropin with clomiphene citrate as compared to gonadotropin with letrozole in conception of infertile women. 
Scientific Title of Study   A comparative study evaluating the efficacy of Gonadotropin in Conjunction with Clomiphene citrate versus Letrozole in Pregnancy rate in women with Ovulatory dysfunction undergoing intrauterine Insemination: A randomized control trial. 
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 SANA AAFREEN 
Designation  JUNIOR RESIDENT DOCTOR 
Affiliation  JNMC WARDHA(DMIHER) 
Address  DEPARTMENT OF OBSTETRICS and GYNAECOLOGY, JNMC, SAWANGI(MEGHE), WARDHA(MH)

Wardha
MAHARASHTRA
442107
India 
Phone  9742569740  
Fax    
Email  sana.afreenxl@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR KAMLESH CHAUDHARI  
Designation  PROFESSOR 
Affiliation  JNMC WARDHA(DMIHER) 
Address  DEPARTMENT OF OBSTETRICS and GYNAECOLOGY, JNMC, SAWANGI(MEGHE), WARDHA(MH)

Wardha
MAHARASHTRA
442107
India 
Phone  9320568673  
Fax    
Email  dr.kamleshchaudhari@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR KAMLESH CHAUDHARI  
Designation  PROFESSOR 
Affiliation  JNMC WARDHA(DMIHER) 
Address  DEPARTMENT OF OBSTETRICS and GYNAECOLOGY, JNMC, SAWANGI(MEGHE), WARDHA(MH)

Wardha
MAHARASHTRA
442107
India 
Phone  9320568673  
Fax    
Email  dr.kamleshchaudhari@gmail.com  
 
Source of Monetary or Material Support  
JNMC SAWANGI WARDHA (DMIHER) 
 
Primary Sponsor  
Name  JNMC WARDHA 
Address  DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, JNMC, SAWANGI(MEGHE), WARDHA(MH), 442107 
Type of Sponsor  Research institution and hospital 
 
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 Kamlesh Chaudhari   JNMC Sawangi(Meghe) DMIHER Wardha  1st floor, Department of obstetrics & gynaecology.
Wardha
MAHARASHTRA 		 9320568673

dr.kamleshchaudhari@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee DMIHER   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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Goup L :Gonadotropin with Letrozole   This group will receive Letrozole 2.5 mg BID for 5 days from day 2 of menstrual cycle.Later on HCG trigger will be given when follicle size becomes 18-20 mm 
Comparator Agent  Group C: Gonadotropin with Clomiphene citrate   This group will receive Clomiphene citrate 50 mg BID for 5 days starting from day 2 of menstrual cycle & later on HCG trigger will be given when follicle size becomes 18-20mm 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  38.00 Year(s)
Gender  Female 
Details  Consenting women of Primary & Secondary infertility
Polycystic ovarian syndrome
Cervical factor infertility
Retrograde ejaculation
Patent fallopian tube,
Mild male factor infertility  
 
ExclusionCriteria 
Details  Women with Thyroid dysfunction, Hyperprolactinemia, Endometriosis.
Uterine Pathology
Tubal causes of Infertility  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The Pregnancy Rate;
Assessed: Chemically by a positive Beta HCG levels and Clinically by Ultrasonography  		 Transvaginal USG will be done on days 3 9 12 of the cycle and then every 3 days  
 
Secondary Outcome  
Outcome  TimePoints 
Endometrial Thickness
Dominant Follicles
Perifollicular blood flow
Ovarian hyper stimulation syndrome  		 TVS will be done on days 3 9 12 day of cycle and then every 3 days  
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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 3/ Phase 4 
Date of First Enrollment (India)   10/03/2025 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sana.afreenxl@gmail.com].

  6. For how long will this data be available start date provided 29-01-2025 and end date provided 29-10-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study aims to compare the efficacy of Letrozole+HMG with Clomiphene+HMG in a group of patients with unexplained infertility who had failed to p conceive after previous treatment by Clomiphene alone 
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