| CTRI Number |
CTRI/2018/05/013894 [Registered on: 15/05/2018] Trial Registered Prospectively |
| Last Modified On: |
15/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of effect of Letrozole or Leuprolide for preparing the endometrium(lining of uterus) before transferring frozen embryos |
|
Scientific Title of Study
|
RANDOMISED CONTROL TRIAL COMPRARING PREGNANCY OUTCOME USING LETROZOLE VERSUS GNRH AGONIST DOWNREGULATED HRT FOR ENDOMETRIAL PREPARATION IN WOMEN UNDERGOING FROZEN EMBRYO TRANSFER CYCLES |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gayathri M S |
| Designation |
Junior resident |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCE |
| Address |
Dr Gayathri MS,
Junior resident
Dpt of Obs and Gynae
AIIMS
Ansari Nagar, Delhi
New Delhi
DELHI
110029
India |
| Phone |
7838421681 |
| Fax |
|
| Email |
dr.gayathri012@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neena Malhotra |
| Designation |
Professor,Dpt of OBG |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCE |
| Address |
Dr Neena Malhotra ,
Dpt of Obs and Gynae
AIIMS,
Ansari Nagar,New Delhi
110029
New Delhi
DELHI
110016
India |
| Phone |
9891557707 |
| Fax |
|
| Email |
malhotraneena@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Gayathri M S |
| Designation |
Junior resident |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCE |
| Address |
Dr Gayathri MS,
Dpt of Obs and Gynae
AIIMS
Ansari Nagar,New Delhi
Mredugaythri house,Adoor,PO Kadachira,Kannur, 670621
New Delhi
DELHI
110029
India |
| Phone |
7838421681 |
| Fax |
|
| Email |
dr.gayathri012@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dpt of Obs and Gynae
AIIMS,
Ansari Nagar,New Delhi
Pin 110029 |
|
|
Primary Sponsor
|
| Name |
AIIMSDelhi |
| Address |
Ansari Nagar East, Gautam Nagar, New Delhi, DL 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 |
| Gayathri M S |
All India Institute of Medical Scienc(AIIMS),,Delhi |
ART Centre(IVF LAB)
Department of Obst. And Gynaecolgy,
Third Floor, Main Hospital,
AIIMS, Ansaari Nagar, N.Delhi-pin 110029
New Delhi
DELHI |
7838421681
dr.gayathri012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee,AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Infertility , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
HRT CYCLE |
HRT Cycle- Women will be stated on GnRH-agonist, Luprolide (Injection Lupride 0.5 mg s.c), beginning from day 21 of the preceding cycle and continued until the day of progesterone start. |
| Intervention |
Letrozole (intervention) |
Tab letrozole 2.5mg starting from day3-day7 |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Women undergoing FET with at least 2 embryo vitrified , normal endometrial cavity and willing to participate in study |
|
| ExclusionCriteria |
| Details |
Women undergoing IVF with severe male factor demanding ICSI or surgical sperm extraction , poor responders ( < 3 oocyte retrieved at ovum pick up ), adenomyosis / fibroid , uterine adhesions/uterine cavity’s unsuitable for IVF FET at pre IVF WORKUP, donor oocyte cycle |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1)Clinical pregnancy rate 2)ongoing pregnancy rate |
1)Clinical pregnancy rate 4wk after embryo transfer I.e 6wk POG
2)ongoing pregnancy rate 10 wk of embryo transfer or 12 wk POG |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1)Implantation rate. 2)endometrial thickness and pattern |
1)6wk. 2) 2wk |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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 4 |
|
Date of First Enrollment (India)
|
22/05/2018 |
| 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="2"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Women planned for IVF cycles will undergo pre-treatment assessment as per unit guidelines. Women undergoing IVF cycles for tubal factor, PCOS, unexplained infertility and expected to have an optimal response such that will undergo FET cycles will be recruited after a proper counseling. After embro-cryopreservation women planned for FET and meeting eligibility criteria will be randomly allocated to letrozole stimulated endometrial preparation (Group A) and GnRH-agonist HRT based endometrial preparation (Group B), through computer generated random numbers. Randomization will be done prior to the start of endometrial preparation. |