| CTRI Number |
CTRI/2026/02/103657 [Registered on: 11/02/2026] Trial Registered Prospectively |
| Last Modified On: |
10/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Laser-assisted Laboratory- based procedural intervention] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Survival of IVF Embryos With and Without Laser Treatment Before Freezing |
|
Scientific Title of Study
|
A Prospective Study To Compare The Efectivenes Of Laser-Assisted
Blastocyst Collapse Before Vitrification. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| F.1/IEC/IFS/2026/No.07 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr KD Nayar |
| Designation |
Chief Consultant Infertility and IVF |
| Affiliation |
Akanksha IVF Centre |
| Address |
Room no.628,mata chanan devi hospital,C-1 Janakpuri New Delhi
West DELHI 110058 India |
| Phone |
09810398765 |
| Fax |
|
| Email |
kdnayar@usa.net |
|
Details of Contact Person Scientific Query
|
| Name |
Gaurav Kant |
| Designation |
Chief Embryologist |
| Affiliation |
Akanksha IVF Centre |
| Address |
Room no.628,mata chanan devi hospital,C-1 Janakpuri New Delhi
West DELHI 110058 India |
| Phone |
8750345277 |
| Fax |
|
| Email |
gauravchdry86@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Akansha Negi |
| Designation |
Trainee |
| Affiliation |
Akanksha IVF Centre |
| Address |
Room no.628,mata chanan devi hospital,C-1 Janakpuri New Delhi
West DELHI 110058 India |
| Phone |
8439284183 |
| Fax |
|
| Email |
negi.akansha0328@gmail.com |
|
|
Source of Monetary or Material Support
|
| Akanksha IVF centre, Block C-1 room no.628 mata chanan devi hospital,Janakpuri New Delhi India 110058 |
|
|
Primary Sponsor
|
| Name |
Akanksha Ivf Centre |
| Address |
Block C-1 room no.628 mata chanan devi hospital,Janakpuri New Delhi India 110058 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Akansha Negi |
Akanksha IVF centre |
Room no.628,mata chanan devi hospital,C-1 Janakpuri New Delhi West DELHI |
08439284183
negi.akansha0328@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indian Fertility Society |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Women with repeated IVF Failures |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
34.00 Year(s) |
| Gender |
Female |
| Details |
women aged 21 to 34 years undergoing assisted reproductive treatment |
|
| ExclusionCriteria |
| Details |
women aged more than or equal to 35 years at the time of oocyte retrieval |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Implantation and Pregnancy rate |
Implantation rate: Assessed at 14 days after embryo transfer
Pregnancy rate: Assessed at 6–7 weeks of gestation by ultrasound |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Re-expansion rate of the blastocyst |
2–4 hours after warming (post-thaw culture period) |
|
|
Target Sample Size
|
Total Sample Size="118" Sample Size from India="118"
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)
|
21/02/2026 |
| 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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [negi.akansha0328@gmail.com].
- For how long will this data be available start date provided 01-05-2026 and end date provided 01-05-2031?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Blastocyst vitrification is routinely used in in-vitro fertilization (IVF) programs; however, the presence of a fluid-filled blastocoel may influence post-warming survival and subsequent clinical outcomes. Laser-assisted blastocyst collapse is commonly practiced in many laboratories to reduce blastocoelic volume prior to vitrification, but its impact on post-warming recovery and pregnancy outcomes varies across different clinical settings. This prospective observational study aims to evaluate and compare post-warming survival, re-expansion characteristics, implantation rate, and clinical pregnancy outcomes of blastocysts vitrified with prior laser-assisted collapse and those vitrified without collapse, under routine laboratory conditions. The findings of this study will help assess the effectiveness of laser-assisted blastocyst collapse within the study centre and contribute to evidence-based optimization of blastocyst vitrification practices. |