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CTRI Number  CTRI/2022/03/040793 [Registered on: 04/03/2022] Trial Registered Prospectively
Last Modified On: 03/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Biological 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to find out clinical outcomes with variable durations of testosterone local application gel as pretreatment in patients with suspected poor results in IVF cycles  
Scientific Title of Study   A Randomized Controlled Trial to assess the clinical outcomes with different durations of Transdermal Testosterone gel as pretreatment in patients with Poor prognosis in Antagonist IVF/ICSI cycles 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DRKDNAYAR 
Designation  SENIOR CONSULTANT AND HOD 
Affiliation  AKANKSHA IVF CENTRE 
Address  Department of Reproductive Medicine, Division of Obs and Gynae DEPARTMENT ROOM NO.711 AKANKSHA IVF CENTRE MATA CHANAN DEVI HOSPITAL C-1 JANAKPURI NEW DELHI

West
DELHI
110058
India 
Phone  9810398765  
Fax  25544001  
Email  kdnayar@usa.net  
 
Details of Contact Person
Scientific Query  
Name  DRKDNAYAR 
Designation  SENIOR CONSULTANT AND HOD 
Affiliation  AKANKSHA IVF CENTRE 
Address  AKANKSHA IVF CENTRE DEPARTMENT OF REPRODUCTIVE MEDICINE DIVISION OF OBS AND GYNAE DEPARTMENT ROOM NO.711 MATA CHANAN DEVI HOSPITAL C-1 JANAKPURI NEW DELHI

West
DELHI
110058
India 
Phone  9810398765  
Fax  25544001  
Email  kdnayar@usa.net  
 
Details of Contact Person
Public Query  
Name  DRGARIMA KAUR 
Designation  IFS FELLOW  
Affiliation  AKANKSHA IVF CENTRE 
Address  AKANKSHA IVF CENTRE DEPARTMENT OF REPRODUCTIVE MEDICINE ,DIVISION OF OBS AND GYNAE DEPARTMENT ROOM NO.711 MATA CHANAN DEVI HOSPITAL C-1 JANAKPURI NEW DELHI

West
DELHI
110058
India 
Phone  9313054547  
Fax  25544001  
Email  gary.zest@gmail.com  
 
Source of Monetary or Material Support  
AKANKSHA IVF CENTRE, MATA CHANAN DEVI HOSPITAL C1 JANAKPURI,DELHI 
 
Primary Sponsor  
Name  DRKD NAYAR 
Address  AKANKSHA IVF CENTRE MATA CHANAN DEVI HOSPITAL C-1 JANAKPURI NEW DELHI 
Type of Sponsor  Other [] 
 
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 
DRKD NAYAR  AKANKSHA IVF CENTRE,MATA CHANAN DEVI HOSPITAL  DEPARTMENT OF REPRODUCTIVE MEDICINE DIVISION OF OBS AND GYNAE DEPARTMENT ROOM NO. 711
West
DELHI 		 9810398765
25544001
kdnayar@usa.net 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Indian fertility society  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  no pretreatment  GEL NOT GIVEN before stimulation 
Intervention  TRANSDERMAL TESTOSTERONE GEL  1.25gm testosterone gel once daily(12.5mg testosterone) GIVEN FOR 2,3 AND 4 WEEKS AS PRETREATMENT 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  39.00 Year(s)
Gender  Female 
Details  antral follicle count less than 5
anti mullerian hormone less than/ equal to 1.1ng/ml 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
CLINICAL PREGNANCY RATE  CARDIAC ACTIVITY AT 7WEEKS after last menstrual period 
 
Secondary Outcome  
Outcome  TimePoints 
No. of mature oocytes
miscarriage rates
ongoing pregnancy rates
fertilization rate
implantation rate 		 7months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   07/03/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  07/03/2022 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
All infertility patients will undergo detailed History & examination complete hematological , biochemical & ultrasound screening will be done
AFC is ascertained 5 ml blood sample is sent for Complete blood count, Serum AMH, Blood sugar, Urine-routine & microscopy, TSH, Prolactin, HIV, HbsAg, VDRL and Anti-HCV

to look for inclusion and exclusion criteria

After ethical clearance and proper informed consent patients who fulfil the inclusion criteria will be enrolled into one of the 4 groups randomly by a computer generated randomization program
TVS monitoring would be started on day 2 of menses
Controlled ovarian hyperstimulation with Antagonist protocol followed by either IVF /ICSI at Akanksha IVF Center
Oocyte retrievals will be performed under transvaginal ultrasound guidance 35 - 36 hours after HCG trigger
Fresh embryo transfers will be performed for all cases ,soft catheter will be used for embryo transfer . Transfers & ultrasounds will be done by a single clinician to avoid bias
All embryos will be graded according to Istanbul Consensus 2011
The luteal phase support with vaginal micronized progesterone
Urine pregnancy test will be performed after 14 days of embryo transfer, if positive luteal support will be given until 12th week of pregnancy
 
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