| CTRI Number |
CTRI/2024/11/077034 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
18/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Natural cycle vs Hormonal replacement theraphy in Embryo transfer |
|
Scientific Title of Study
|
Stimulated Natural Cycle Versus Hormone Replacement Therapy Cycle in Frozen-Thawed Embryo Transfer |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSanchaya Selvaraj |
| Designation |
Consultant |
| Affiliation |
Department of Reproductive medicine and Endocrinology |
| Address |
Room no: 3
A4 Hospital and Fertility centre
87, Arcot Rd, AVM Avenue, Virugambakkam, Chennai, Tamil Nadu 600092
Chennai
TAMIL NADU
600092
India |
| Phone |
9841354321 |
| Fax |
|
| Email |
drsanchaya@a4fertility.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSanchaya Selvaraj |
| Designation |
Consultant |
| Affiliation |
Department of Reproductive medicine and Endocrinology |
| Address |
Room no: 3
A4 Hospital and Fertility centre
87, Arcot Rd, AVM Avenue, Virugambakkam, Chennai, Tamil Nadu 600092
TAMIL NADU
600092
India |
| Phone |
9841354321 |
| Fax |
|
| Email |
drsanchaya@a4fertility.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSanchaya Selvaraj |
| Designation |
Consultant |
| Affiliation |
Department of Reproductive medicine and Endocrinology |
| Address |
Room no: 3
A4 Hospital and Fertility centre
87, Arcot Rd, AVM Avenue, Virugambakkam, Chennai, Tamil Nadu 600092
TAMIL NADU
600092
India |
| Phone |
9841354321 |
| Fax |
|
| Email |
drsanchaya@a4fertility.com |
|
|
Source of Monetary or Material Support
|
| A4 Hospital and Fertility centre
No 87 Arcot road Virugambakkam
Chennai - 600092
Tamilnadu |
|
|
Primary Sponsor
|
| Name |
DrSanchaya Selvaraj |
| Address |
Room no: 3
Department of Reproductive medicine
A4 Hospital and Fertility centre
No 87 Arcot road Virugambakkam
Chennai - 600092
Tamilnadu |
| Type of Sponsor |
Other [Other (Dr.Sanchaya Selvaraj) ] |
|
|
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 |
| DrSanchaya Selvaraj |
A4 Hospital and Fertility centre |
Room No: 3
Department of Reproductive medicine
A4 Hospital and Fertility centre
No 87 Arcot road Virugambakkam
Chennai - 600092
Tamilnadu
Chennai
TAMIL NADU |
09841354321
drsanchaya@a4fertility.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| A4 Hospital - instituitional ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N972||Female infertility of uterine origin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
HRT ( ESTRADIOL HEMIHYDRATE ) |
WILL RECEIVE HORMONE REPLACEMENT THERAPY FOR ENDOMETRIAL PREPARATION FOR 2-3 DAYS |
| Intervention |
HRT (LETROZOLE) |
WILL RECEIVE MILDLY STIMULATED NATURAL CYCLE FOR ENDOMETRIAL PREPARATION FOR 2 TO 3 WEEKS |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
ICSI followed by FET.
Atleast one good quality embryo available for transfer.
|
|
| ExclusionCriteria |
| Details |
ET less than 7mm.
Women with medical complications such as Hypertension , Diabetes |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical pregnancy rate – USG confirmation of gestational sac and fetal heart rate four weeks after embryo transfer.
|
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Implantation rate – presence of an intrauterine gestational sac 2-3 weeks after embryo transfer.
Live birth rate. |
12 months |
|
|
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)
|
02/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
02/12/2024 |
| 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 Yet Recruiting |
| 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
|
•Stimulated Natural cycle versus hormone replacement therapy cycle in frozen-thawed embryo transfer.Currently, there is an increasing interest in the method of endometrial preparation for Frozen embryo transfer. Optimal Endometrial preparation helps in improving the implantation rates, and reduces miscarriages and pregnancy complications. MILDLY STIMULATED MODIFIED NATURAL CYCLE: For the preparation of patients in the natural cycle group, Letroz 5mg will be from the D2/D3 of the cycle, after a baseline USG. •Patient is advised to come on D8 – for follicular monitoring. •When the dominant follicle is greater than 18 mm, Sr. Progesterone will be checked and hCG 10000 U will be administered as Trigger. •If the Sr. Progesterone value is less than 0.8ng/ml, Endometrium is primed with Progesterone. •Embryo Transfer is done on Day 6 of Progesterone. HRT : The patients in the HRT cycle group are administered estradiol valerate between day 2- day 3 of the cycle, after a baseline scan. •Patients will review for USG on the on D9/D10 of their cycle. •When adequate endometrial thickness is attained, Sr. Progesterone level is checked. •If the Sr. Progesterone value is less than 0.8ng/ml, Endometrium is primed with Progesterone. •The embryos were thawed and transferred on Day 6 of Progesterone. •The patients in the HRT cycle group are administered estradiol valerate between day 2- day 3 of the cycle, after a baseline scan. •Patients will review for USG on the on D9/D10 of their cycle. •When adequate endometrial thickness is attained, Sr. Progesterone level is checked. •If the Sr. Progesterone value is less than 0.8ng/ml, Endometrium is primed with Progesterone. •The embryos were thawed and transferred on Day 6 of Progesterone. |