| CTRI Number |
CTRI/2025/02/080120 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to see the efficacy of Atosiban given before Embryo Transfer on In vitro Fertilisation |
|
Scientific Title of Study
|
A Randomized Controlled Trial to study the efficacy of administration of Atosiban before Embryo Transfer on In vitro Fertilisation |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K D Nayar |
| Designation |
Chief Consultant |
| Affiliation |
Akanksha IVF Centre New Delhi |
| Address |
Akanksha IVF Centre
Department of Reproductive Medicine
Room no 628
Test Tube Baby Centre at Mata Chanan Devi Hospital
C1 Janakpuri New Delhi
New Delhi
DELHI
110058
India |
| Phone |
9810398765 |
| Fax |
|
| Email |
kdnayar@usa.net |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aashna Arora |
| Designation |
Fellow |
| Affiliation |
Akanksha IVF Centre |
| Address |
Akanksha IVF Centre
Department of Reproductive Medicine
Room no 628
Test Tube Baby Centre at Mata Chanan Devi Hospital
C1 Janakpuri New Delhi
New Delhi
DELHI
110058
India |
| Phone |
9315489342 |
| Fax |
|
| Email |
aashnalhmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aashna Arora |
| Designation |
Fellow |
| Affiliation |
Akanksha IVF Centre |
| Address |
Akanksha IVF Centre
Department of Reproductive Medicine
Room no 628
Test Tube Baby Centre at Mata Chanan Devi Hospital
C1 Janakpuri New Delhi
New Delhi
DELHI
110058
India |
| Phone |
9315489342 |
| Fax |
|
| Email |
aashnalhmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Akanksha IVF Centre, Mata Chanan Devi Hospital, C-1, Janakpuri,New Delhi-110058 |
|
|
Primary Sponsor
|
| Name |
Akanksha IVF Centre |
| Address |
Department of Reproductive Medicine
Room no 628
Test Tube Baby Centre at Mata Chanan Devi Hospital
C 1 Janakpuri New Delhi 110058 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Aashna Arora |
Akanksha IVF Centre |
Department of Reproductive Medicine
Room no 628
Test Tube Baby Centre at Mata Chanan Devi Hospital
New Delhi 110058
New Delhi
DELHI |
9315489342
aashnalhmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee,Indian Fertility Society |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N83||Noninflammatory disorders of ovary, fallopian tube and broad ligament, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Atosiban |
To give Atosiban (Uterine muscle relaxant), 6.75mg/0.9ml intravenous bolus to the patient , 30 minutes prior to Embryo transfer |
| Comparator Agent |
No treatment |
No treatment |
|
|
Inclusion Criteria
|
| Age From |
23.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1 BMI less than 30kg per m2
2 Diagnosed with primary or secondary infertility
3 Normal uterus on 2D ultrasonography
4 Endometrial thickness greater than 7mm on the day of starting progesterone
5 Good quality embryo (Grade A Cleavage stage embryo or blastocyst) |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical pregnancy rate
Clinical pregnancy rate= Number of clinical pregnancies/Number of Embryo transfer cycles*100
|
2 months
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Implantation rate
2 Biochemical pregnancy
3 First trimester miscarriage |
2 months
4 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
18/02/2025 |
| 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="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
|
Embryo implantation is the most crucial stage in assisted reproduction treatment. Uterine contractions triggered by the embryo transfer process might negatively impact embryo implantation. The impact of Atosiban on embryo implantation is related to the inverse correlation between the frequency of uterine contractions and the implantation rate. Aims and Objectives: To study the effect of Atosiban administration before embryo transfer on In vitro Fertilisation. Material and methods: A total of 100 women undergoing FET at Akanksha IVF centre fulfilling the inclusion and exclusion criteria will be included in the Randomized Controlled Trial. Atosiban I.V. bolus of 6.75mg will be administered at approximately 30 minutes before Embryo transfer. Pregnancy outcome will be assessed in terms of implantation rate, biochemical pregnancy, clinical pregnancy and first trimestere miscarriage. |