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CTRI Number  CTRI/2025/03/082224 [Registered on: 12/03/2025] Trial Registered Prospectively
Last Modified On: 11/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   There is association of serum est radio land progesterone levels one day prior to frozen embryo transfer with clinical pregnancy rate  
Scientific Title of Study   Association of serum estradiol and progesterone levels one day prior to frozen embryo transfer with clinical pregnancy outcome 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rashi Verma 
Designation  Post graduate resident 
Affiliation  Vardhman Mahavir medical college and Safdarjung hospital  
Address  IVF centre, department if obstetrics and gynaecology, Vardhman Mahavir medical college and Safdarjung hospital, Ansari nagar west , New Delhi , 110029

South
DELHI
110029
India 
Phone  7838977663  
Fax  9101126163072  
Email  rashiverma299@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bindu Bajaj  
Designation  HOD , department of obstetrics and gynaecology  
Affiliation  Vardhman Mahavir medical college and Safdarjung hospital  
Address  Vardhman Mahavir medical college and Safdarjung hospital, Ansari nagar west , New Delhi , 110029


DELHI
110029
India 
Phone  9711067661  
Fax  9101126163072  
Email  bindubajaj15@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rashi Verma 
Designation  Post graduate resident 
Affiliation  Vardhman Mahavir medical college and Safdarjung hospital  
Address  IVF CENTER, DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY Vardhman Mahavir medical college and Safdarjung hospital, Ansari nagar west , New Delhi , 110029

South
DELHI
110029
India 
Phone  7838977663  
Fax  9101126163072  
Email  rashiverma299@gmail.com  
 
Source of Monetary or Material Support  
Vardhman Mahavir medical college and Safdarjung hospital, Ansari nagar east , New Delhi , India 110029 
 
Primary Sponsor  
Name  Vardhman Mahavir medical college and Safdarjung hospital 
Address  Vardhman Mahavir medical college and Safdarjung hospital , Ansari nagar west, New Delhi 110029 
Type of Sponsor  Government medical college 
 
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 Rashi Verma   Vardhman Mahavir medical college and Safdarjung hospital   IVF centre, department of obstetrics and gynaecology, VMMC and SJH Safdarjung hospital , Ansari nagar east , New Delhi 110029
South
DELHI 
7838977663

rashiverma2199@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethic committee , VMMC & SJH  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, (2) ICD-10 Condition: N979||Female infertility, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil   Nil 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  All patients needing frozen embryo transfer will undergo endometrial preparation with estradiol valerate followed by micronised progesterone 100 mg I/m. Once endometrial thickness becomes more than equal to 7mm and both ovaries show non dominant follicles on TVS .
FET in done  
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Intrauterine gestational sac with cardiac activity  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Pregnancy of unknown origin
Ectopic pregnancy
Blighted ovum
Missed abortion 
4week  
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   24/03/2025 
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 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  

Frozen embryo transfer (FET) has increased in prevalence amongall ART cycles. As use increases it is important to identify factors that improve outcomes. Several known predictors include age,number, and quality of frozen embryos. Another vital aspect is the ‘window of implantation’1, the period when the endometrium is most receptive.2 Progesterone is essential for support of the endometrium and implantation of an embryo in the normal menstrual cycle. This state is induced through an interplay of hormones including estrogen and progesterone.3 When performing FETs an attempt is made to replicate the natural hormonal environment.

GnRH agonist is administered for pituitary down regulation which in turn inhibits the secretion of LH and disturbs endogenous production of progesterone. As the endogenous production of progesterone requires a functioning corpus luteum that is not present in programed cycles., Therefore progesterone supplementation is recommended in these women as luteal phase support to make endometrium secretory and maintain pregnancy4.Hormone replacement therapy (HRT) comprising of both estradiol and progesterone was given to the patients.

According to previously established studies, progesterone luteal support increases the clinical outcome of FETs. Patients who received progesterone luteal support had higher clinical and biochemical pregnancies with increased chances of live birth and lower miscarriage rate.

Even though the adequate level of progesterone on the day of embryo transfer has an undeniable effect on clinical outcomes of FET, there are growing pieces of evidence regarding the nonlinearassociation between serum progesterone levels and such outcomes. There is an optimal window for progesterone values in luteal phases that is in controversy with the traditional belief that higher values of progesterone will lead to better clinical outcomes in FET. If the progesterone level is above an optimum level, this may decrease the pregnancy rate. It might be due to premature luteinization and its subsequent impairment in receptivity of the endometrium.5-8 This study is undertaken to determine the association of serum estradiol and progesterone levels one day prior to FET with the clinical pregnancy rate.

 
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