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CTRI Number  CTRI/2026/02/104230 [Registered on: 18/02/2026] Trial Registered Prospectively
Last Modified On: 17/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study to Compare Embryo Development from Sibling Eggs Using ICSI in Different Culture Media 
Scientific Title of Study   Assessment of Embryo Developmental Outcomes from Sibling Oocytes Subjected to ICSI in Sodium Bicarbonate-Buffered Versus HEPES-Buffered Media 
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 KD Nayar 
Designation  Chief Consultant IVF 
Affiliation  Akanksha IVF Centre, Mata Chanan Devi Hospital, Janakpuri, New Delhi 
Address  Akanksha IVF Centre, Mata Chanan Devi Hospital, Janakpuri, New Delhi

West
DELHI
110058
India 
Phone  98103 98765  
Fax    
Email  kdnayar@usa.net  
 
Details of Contact Person
Scientific Query  
Name  Simran Kochhar 
Designation  Fellow embryologist  
Affiliation  Akanksha IVF, Room 628, Mata Chanan Devi Hospital  
Address  11/67, Block 11 , Subhash Nagar, Delhi

West
DELHI
110027
India 
Phone  9646943744  
Fax    
Email  simrankochhar123@gmail.com  
 
Details of Contact Person
Public Query  
Name  Simran Kochhar 
Designation  Fellow embryologist  
Affiliation  Akanksha IVF, Room 628, Mata Chanan Devi Hospital  
Address  11/67, Block 11 , Subhash Nagar, Delhi

West
DELHI
110027
India 
Phone  9646943744  
Fax    
Email  simrankochhar123@gmail.com  
 
Source of Monetary or Material Support  
Akanksha IVF Centre, Room no. 628, Mata Chanan Devi Hospital, Janakpuri, Delhi, India Pincode- 110058 
 
Primary Sponsor  
Name  Akanksha IVF Centre 
Address  Mata chanan Devi Hospital, Room 628, Janakpuri, Delhi, India Pincode-110058 
Type of Sponsor  Private hospital/clinic 
 
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 KD Nayar  Akanksha IVF Centre  Akanksha IVF Centre, Room-628, Mata Chanan Devi Hospital, Janakpuri, Delhi, India Pincode-110058
West
DELHI 		 98103 98765

Kdnayar@usa.net 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Independent Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patients with infertility. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  ICSI in HEPES-Buffered Culture Medium  Sibling oocytes from the same participant will undergo intracytoplasmic sperm injection (ICSI) followed by embryo culture in HEPES-buffered medium. Embryo developmental outcomes will be assessed and compared with the intervention group. 
Intervention  ICSI in Sodium Bicarbonate-Buffered Culture Medium  Sibling oocytes will undergo intracytoplasmic sperm injection (ICSI) followed by embryo culture in sodium bicarbonate-buffered medium. Embryo developmental outcomes will be assessed and recorded. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Women between the ages of 25-35 years 
 
ExclusionCriteria 
Details  Severe male factors and poor ovarian response ( less than 5 oocytes) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare embryo developmental outcome i.e blastocyst
formation rate between sibling oocytes subjected to ICSI (bicarbonate-buffered medium,
and HEPES-buffered medium.) 		 Baseline (Day 0):
At the time of intracytoplasmic sperm injection (ICSI) and allocation of sibling oocytes to sodium bicarbonate-buffered or HEPES-buffered media.

Day 1 (16–18 hours post-ICSI):
Assessment of fertilization outcome.

Day 3 (68–72 hours post-ICSI):
Assessment of cleavage-stage embryo development and quality.

Day 5/6 post-ICSI :
Assessment of blastocyst formation and quality. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare fertilization rates (2PN formation) between the two media.
To assess cleavage, blastomere symmetry, fragmentation, & multinucleation were assessed.
Blastocyst formation rate, expansion grade, ICM grade, & TE grade were evaluated.
To determine whether transient exposure to HEPES during ICSI affects downstream embryo viability and
usability rates.
To generate evidence for refining standard operating procedures in ICSI laboratories. 		 Baseline (Day 0):
At the time of intracytoplasmic sperm injection (ICSI) & allocation of sibling oocytes to sodium bicarbonate-buffered or HEPES-buffered media.

Day 1 (16–18 hours post-ICSI):
Assessment of fertilization outcome.

Day 3 (68–72 hours post-ICSI):
Assessment of cleavage-stage embryo development & quality.

Day 5/6 post-ICSI :
Assessment of blastocyst formation & quality. 
 
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 4 
Date of First Enrollment (India)   01/03/2026 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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

  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 [simrankochhar123@gmail.com].

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    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 prospective randomized sibling oocyte study compares bicarbonate buffered and HEPES buffered media used during ICSI to evaluate their effect on fertilization embryo cleavage and blastocyst development up to day five under strict laboratory conditions using standard embryo grading guidelines.


 
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