| CTRI Number |
CTRI/2020/07/026931 [Registered on: 31/07/2020] Trial Registered Prospectively |
| Last Modified On: |
28/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational |
| Study Design |
Other |
|
Public Title of Study
|
Role of progesterone levels in prediction of pregnancy in cryo embryo transfers |
|
Scientific Title of Study
|
Role of progesterone levels in prediction of clinical pregnancy in cryo embryo transfers. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kagita vasudha bhargavi |
| Designation |
Postgraduate |
| Affiliation |
Maulana Azad medical college |
| Address |
Department of obs and gynaec,Loknayak resident doctor hostel,Maulana Azad medical college,bhadurshah zafar marg,newdelhi
New Delhi
DELHI
110002
India |
| Phone |
7386056395 |
| Fax |
|
| Email |
vasudhak139@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anjali Tempe |
| Designation |
Director professor |
| Affiliation |
Maulana Azad medical college |
| Address |
Department of obs and gynaec, Loknayak hospitals,bhadurshah Zafar Marg,newdelhi.
New Delhi
DELHI
110002
India |
| Phone |
9968604343 |
| Fax |
|
| Email |
anjalitempe@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anjali Tempe |
| Designation |
Director professor |
| Affiliation |
Maulana Azad medical college |
| Address |
Department of obs and gynaec, Loknayak hospitals,bhadurshah Zafar Marg,newdelhi.
New Delhi
DELHI
110002
India |
| Phone |
9968604343 |
| Fax |
|
| Email |
anjalitempe@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad medical college, bhadurshah zafarmarg,newdelhi,110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad medical college |
| Address |
Department of obs and gynaec,Loknayak hospitals, bhadurshah zafarmarg.,newdelhi |
| 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 |
| Kagita vasudha bhargavi |
Loknayakhospitals |
Department of obs and gynaec,
New Delhi
DELHI |
7386056395
vasudhak139@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
All ivf women seeking ivf treatment for cryoembryotransfers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
2 or 3 good blastocysts of cryo embryo transfers |
|
| ExclusionCriteria |
| Details |
Fresh embryotransfers
More than 45 years.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical pregnancy rate. |
14wks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Implantation rate,retrieval rate,miscarriage rate |
6-10 days after ovulation.
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
03/08/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
An observational prospective study of measuring progesterone levels on the day of embryo transfer and day 8 of luteal cycle and correlating the same with pregnancy.In this study,estrogen priming till endometrium reaches 6.5 mm followed by progesterone supplementation and then cryo embryo transfers is done .These women are followed till 5-6 weeks of gestation for the presence of sac/cardiac activity(primary outcome)and followed till 14 weeks to confirm ongoing pregnancy. |