| CTRI Number |
CTRI/2025/04/084727 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
14/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
This is observational study to observe the effectiveness and safety of estradiol hemihydrate tablet. |
| Study Design |
Other |
|
Public Title of Study
|
This is a study to observe the effectiveness and safety of estradiol hemihydrate tablet usage vaginally in patients with thin endometrial for endometrial preparation in Frozen Embryo Transfer (FET) cycles |
|
Scientific Title of Study
|
A retrospective investigator-initiated study to observe the effectiveness and safety of estradiol
hemihydrate tablet usage vaginally in patients with thin endometrial for endometrial preparation in
Frozen Embryo Transfer (FET) cycles |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol No: 0020-25, Version: 1.0, Dated: 10 Dec 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jatin Shah |
| Designation |
Principal Investigator |
| Affiliation |
Kamala Poly Clinic & Nursing Home |
| Address |
66-C, Motiwala Building, 1st Floor, A K Marg, West, Opposite Aung Kranti Maidan, Gowalia Tank, Grant Road, Mumbai, Maharashtra- 400025, India
Mumbai
MAHARASHTRA
400025
India |
| Phone |
9820080449 |
| Fax |
9820080449 |
| Email |
drjatin2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jatin Shah |
| Designation |
Principal Investigator |
| Affiliation |
Kamala Poly Clinic & Nursing Home |
| Address |
66-C, Motiwala Building, 1st Floor, A K Marg, West, Opposite Aung Kranti Maidan, Gowalia Tank, Grant Road, Mumbai, Maharashtra- 400025, India
MAHARASHTRA
400025
India |
| Phone |
9820080449 |
| Fax |
9820080449 |
| Email |
drjatin2000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jatin Shah |
| Designation |
Principal Investigator |
| Affiliation |
Kamala Poly Clinic & Nursing Home |
| Address |
66-C, Motiwala Building, 1st Floor, A K Marg, West, Opposite Aung Kranti Maidan, Gowalia Tank, Grant Road, Mumbai, Maharashtra- 400025, India
MAHARASHTRA
400025
India |
| Phone |
9820080449 |
| Fax |
9820080449 |
| Email |
drjatin2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Jatin Shah, Kamala Poly Clinic & Nursing Home, 66-C, Motiwala Building, 1st Floor, A K Marg, West, Opposite Aung Kranti Maidan, Gowalia Tank, Grant Road, Mumbai, Maharashtra- 400025, India
|
|
|
Primary Sponsor
|
| Name |
Dr Jatin Shah |
| Address |
Kamala Poly Clinic & Nursing Home, 66-C, Motiwala Building, 1st Floor, A K Marg, West, Opposite Aung Kranti Maidan, Gowalia Tank, Grant Road, Mumbai, Maharashtra- 400025, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Jatin Shah |
Kamala Poly Clinic & Nursing Home |
Department of Clinical
Research, Room No.
NA, 66-C, Motiwala Building, 1st Floor, A K Marg, West, Opposite Aung Kranti Maidan, Gowalia Tank, Grant Road, Mumbai, Maharashtra- 400025, India
Mumbai
MAHARASHTRA |
9820080449
drjatin2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indira IVF Hospital Ethics Committee- Mumbai, Dr. Jatin Shah |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
42.00 Year(s) |
| Gender |
Both |
| Details |
a. Age 25 to 42 years (both inclusive)
b. Patients planned to undergo Frozen embryo transfer cycle where endometrial preparation will be
done by hormone replacement therapy (HRT)
c. Normal pelvic ultrasonography |
|
| ExclusionCriteria |
| Details |
a. Women who smoke
b. Women under 25 years or over 42 years of age
c. Women who had unexplained vaginal bleeding
d. Women who had Ashermans syndrome
e. Women with history of Malignancy, HIV and Tubercular endometritis
g. Any Contraindications for receiving estradiol
h. Hypersensitivity to estradiol or any of its excipients
i. Any other condition which precludes the use of estradiol |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
A retrospective real world observational study to observe the effectiveness and safety of estradiol
hemihydrate tablet usage vaginally in patients with thin endometrial for artificial endometrial
preparation in Frozen Embryo Transfer (FET) cycles |
Following retrospective data will be collected in this study.
• Patients Age
• Duration and cause of Infertility
• Number of previous IVF treatment cycle
• Base line investigations
• Endometrial thickness - before starting and after administration of vaginal estradiol
hemihydrate; and on progesterone start day
• Pregnancy test - positive or negative 10 to 15 days after embryo |
|
|
Secondary Outcome
|
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
25/04/2025 |
| 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="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 - NO
|
|
Brief Summary
|
This is a retrospective real world observational study to observe the effectiveness and safety of estradiol hemihydrate tablet usage vaginally in patients with thin endometrial for artificial endometrial preparation in Frozen Embryo Transfer (FET) cycles |