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CTRI Number  CTRI/2024/07/071335 [Registered on: 25/07/2024] Trial Registered Prospectively
Last Modified On: 21/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two oral drugs for ovulation in women with unexplained infertility: Randomised Control Trial.  
Scientific Title of Study   Comparison of efficacy of clomiphene citrate and tamoxifen for controlled ovarian stimulation in women with unexplained infertility: Randomised 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 Deepika Singh  
Designation  Post graduate resident 
Affiliation  Lady Hardinge medical college and associated hospitals 
Address  room number 102,ART centre, infertlity unit(division), OPD building, obstetrics and gynecology department, Lady Hardinge medical college and associated hospitals, Connaught place

New Delhi
DELHI
110001
India 
Phone  09289358525  
Fax    
Email  deepikasingh9196@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pikee Saxena  
Designation  Director Professor 
Affiliation  Lady Hardinge medical college and associated hospitals 
Address  room number 101,ART centre,infertlity unit(division), OPD building, obstetrics and gynecology department, Lady Hardinge medical college and associated hospitals, Connaught place

New Delhi
DELHI
110001
India 
Phone  9868223323  
Fax    
Email  pikeesaxena@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pikee Saxena  
Designation  Director Professor 
Affiliation  Lady Hardinge medical college and associated hospitals 
Address  room number 101,ART centre,infertlity unit(division), OPD building, obstetrics and gynecology department, Lady Hardinge medical college and associated hospitals, Connaught place

New Delhi
DELHI
110001
India 
Phone  9868223323  
Fax    
Email  pikeesaxena@gmail.com  
 
Source of Monetary or Material Support  
Lady Hardinge medical college and associated hospitals, Connaught place, New Delhi-110001 
 
Primary Sponsor  
Name  Deepika Singh 
Address  Lady Hardinge medical college and associated hospitals, Connaught place, New Delhi-110001 
Type of Sponsor  Other [Self] 
 
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 Deepika Singh  Lady Hardinge Medical College and associated hospitals  room number 101,ART centre, infertility unit(division), OPD building, obstetrics and gynecology department, Lady Hardinge medical college and associated hospitals, Connaught place,New Delhi-110001
New Delhi
DELHI 		 09289358525

deepikasingh9196@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Lady Hardinge Medical College and associated hospitals   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N979||Female infertility, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Clomiphene citrate   Group A will receive clomiphene citrate 50mg orally from day 2 to day 6 of menstrual cycle for 3 cycles. If patient does not ovulate in the first cycle then dose will be increased to 100mg in subsequent cycles. 
Comparator Agent  Tamoxifen  Group B will receive tamoxifen 20 mg from day 2 to day 6 for three cycles. If patient does not ovulate in the first cycle then dose will be increased to 40 mg in subsequent cycles. 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  38.00 Year(s)
Gender  Female 
Details  Women with unexplained infertility (whether primary or secondary in which couple fails to achieve pregnancy after 1 year of unprotected and regular intercourse) with following criteria:
1 Normal husband semen analysis
2 Patent fallopian tube on HSG/ chromopertubation
3 Normal uterine cavity on USG
4 Normal ovulatory function.
 
 
ExclusionCriteria 
Details  Patients with any of the following:
1 Hormonal imbalance (hypothyroidism, insulin resistance and hyperprolactinemia)
2 History of ovarian or uterine tumour
3 AFC less than 5, AMH less than 1ng/ml
4 BMI greater than 35kg/m2 or higher
5 Resistance to clomiphene citrate or tamoxifen
6 Predicted decreased endometrial receptivity ,intrauterine abnormalities, adhesions and chronic endometritis, uterine polyp or submucosal fibroid).
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Comparison of mean number of dominant follicles formed during controlled ovulation stimulation among clomiphene citrate and tamoxifen over 3 cycles.   3 months  
 
Secondary Outcome  
Outcome  TimePoints 
To compare the following parameters among the two drugs.
1.Mean Endometrial thickness
2.Mean resistivity index and pulsatility index of ovarian and uterine artery
3.Mid luteal serum progesterone.
4.Proportion of women with biochemical pregnancy by measuring beta HCG levels / urine pregnancy test
5.Proportion of women with clinical pregnancy rates ( detected by G sac visualization on transvaginal ultrasound)
6.Proportion of women with Ovarian Hyperstimulation Syndrome (OHSS)
7.Proportion of women with multiple gestation
8.Proportion of women who have miscarriages
 		 3 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/08/2024 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [deepikasingh9196@gmail.com].

  6. For how long will this data be available start date provided 09-01-2026 and end date provided 09-01-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

      For women with unexplained infertility, COS is done with oral ovulogens , clomiphene citrate and tamoxifen, superiority of one over the other is not yet established. In this study, two oral ovulogens, clomiphene citrate and tamoxifen will be compared for evaluating the efficacy and safety for controlled ovarian stimulation over 3 cycles in women with unexplained infertility. Concealed allocation by placing in sealed envelopes will be done. Each women will be assigned one envelope and would be categorized into group A and B .Group A will receive clomiphene citrate 50mg orally from day 2 to day 6 of menstrual cycle for 3 cycles. If patient does not ovulate in the first cycle then dose will be increased to 100mg in subsequent cycle .Group B will receive tamoxifen 20 mg from day 2 to day 6 for three cycles. If patient does not ovulate in the first cycle then dose will be increased to 40 mg in subsequent cycle. Comparison of mean number of dominant follicles formed during controlled ovulation stimulation among clomiphene citrate and tamoxifen over 3 cycles will be done. Further ,Mean Endometrial thickness, Mean resistivity index and pulsatility index of ovarian and uterine artery, Proportion of women with biochemical pregnancy (urine pregnancy test positive), Proportion of women with clinical pregnancy will be compared over the 3 cycles.

 
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