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CTRI Number  CTRI/2026/02/105028 [Registered on: 27/02/2026] Trial Registered Prospectively
Last Modified On: 24/02/2026
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 Standard Versus Personalised hormone (progesterone) Support in Women Undergoing IVF and Its impact on Pregnancy Outcomes 
Scientific Title of Study   Comparison of Standard versus Personalised Luteal Phase Support in patients undergoing frozen-thawed embryo transfer cycles: an open labelled randomised controlled 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 Aaroshi Gupta 
Designation  Junior Resident  
Affiliation  AIIMS Delhi  
Address  701, 7th floor, Mother and Child block, Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Ansari Nagar New Delhi 110029

South West
DELHI
110029
India 
Phone  8527361366  
Fax    
Email  aaroshig2001@aiims.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Neena Malhotra  
Designation  Professor and Head of Department  
Affiliation  AIIMS Delhi 
Address  701, 7th floor, Mother and Child block, Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Ansari Nagar New Delhi 110029

South West
DELHI
110029
India 
Phone  9891557707  
Fax    
Email  malhotraneenaaiims@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Neena Malhotra  
Designation  Professor and Head of Department  
Affiliation  AIIMS Delhi 
Address  701, 7th floor, Mother and Child block, Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Ansari Nagar New Delhi 110029

South West
DELHI
110029
India 
Phone  9891557707  
Fax    
Email  malhotraneenaaiims@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi, Delhi - 110029, India 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences (AIIMS), New Delhi  
Address  All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi - 110029, India 
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 Aaroshi Gupta   AIIMS Delhi   All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi - 110029, India
South West
DELHI 		 8527361366

Aaroshig2001@aiims.edu  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute of ethics Committee AIIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N97||Female infertility,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Personalised Luteal Phase Support  Serum progesterone will be first measured on the day of embryo transfer. Serum progesterone levels will be repeated serially on day 7 post embryo transfer, day of pregnancy test (day 14 of embryo transfer) and 6 weeks of gestation. Patients with serum progesterone greater than or equal to 10ng/ml will be continued on the same dosage i.e. vaginal micronized progesterone 800mg daily, and those with lesser than 10ng/ml at any checkpoint, will receive additional progesterone supplement in form of Inj aqueous progesterone 25mg subcutaneous daily which can be escalated to 50 mg subcutaneous daily and then further to intramuscular progesterone 100 mg daily (instead of subcutaneous) along with vaginal progesterone if the serum levels of P4 are less than 10ng/ml at the next checkpoint. The luteal phase support will be continued till 12 weeks of gestation. 
Comparator Agent  Standard Luteal Phase Support  Serum progesterone will be measured on the day of embryo transfer. Patients with serum progesterone greater than or equal to 10ng/ml will be continued on the same dosage i.e. vaginal micronized progesterone 800mg daily, and those with lesser than 10ng/ml will receive additional progesterone supplement in form of Inj aqueous progesterone 25mg subcutaneous. No further modification in progesterone supplementation will be done irrespective of serum progesterone levels in this arm according to the standard protocol followed in the institute. The luteal phase support will be continued till 12 weeks of gestation. 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Patients undergoing frozen-thawed embryo transfer cycles
2. Age: 21–40 years old.
3. Availability of at least one good quality embryo (Day 5- 3BB and
beyond, Day 3- 6 celled, grade B and beyond)
4. Willing to give consent 
 
ExclusionCriteria 
Details  1. Recurrent implantation failures (more than or equal to 3 failed transfers)
2. Diffuse adenomyosis
3. Multiple fibroids
4. Refusal to participate in study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Clinical pregnancy rate: Presence of an intrauterine gestational sac with
foetal cardiac activity, confirmed on transvaginal ultrasound 		 at 6 weeks of gestation
 
 
Secondary Outcome  
Outcome  TimePoints 
Biochemical pregnancy rate (UPT positive)  5 weeks gestation 
Miscarriage rate  12 weeks gestation 
ongoing pregnancy rate   at 12 weeks of gestation 
Serum progesterone levels  on the day of embryo transfer, day 7 post
embryo transfer, day of pregnancy test (day 14 of embryo transfer), 6
weeks of gestation 
 
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   Phase 3 
Date of First Enrollment (India)   01/05/2026 
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="1"
Months="10"
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 - NO
Brief Summary  

The primary objective of our study is to compare the clinical pregnancy rates between women receiving personalised serial progesterone-guided rescue luteal phase support and those receiving standard luteal phase support during frozen-thawed embryo transfer cycles. The secondary objectives include 1. comparison of other pregnancy outcomes, including biochemical pregnancy rates, miscarriage rates, and ongoing pregnancy rates between women receiving personalised serial progesterone guided rescue luteal phase support and those receiving standard luteal phase support during frozen-thawed embryo transfer cycles 2. To study the trend of serum progesterone level at different time points- day of embryo transfer, day 7 of ET, day of pregnancy test (day 14 of embryo transfer), at 6 weeks of gestation in both the groups across various protocols of Frozen thawed embryo transfer cycles.

 
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