| 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
|
|
|
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
|
|
|
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 |
|
|
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. |