| CTRI Number |
CTRI/2024/11/076392 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
29/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Clinical efficacy of Atosiban in different doses for patients during embryo transfer |
|
Scientific Title of Study
|
A Randomized controlled trial to evaluate the efficacy of Atosiban in patients undergoing 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 |
Sree Supriya M |
| Designation |
Fertility consultant |
| Affiliation |
A4 Hospital and Fertility centre |
| Address |
A4 Hospital and Fertility centre
Room No: 4
87 Arcot road , Virugambakkam
Chennai
Chennai
TAMIL NADU
600092
India |
| Phone |
9750878983 |
| Fax |
|
| Email |
drsreesupriya@a4fertility.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sree Supriya M |
| Designation |
Fertility consultant |
| Affiliation |
A4 Hospital and Fertility centre |
| Address |
A4 Hospital and Fertility centre
Room No: 4
87 Arcot road , Virugambakkam
Chennai
Chennai
TAMIL NADU
600092
India |
| Phone |
9750878983 |
| Fax |
|
| Email |
drsreesupriya@a4fertility.com |
|
Details of Contact Person
Public Query
|
| Name |
Sree Supriya M |
| Designation |
Fertility consultant |
| Affiliation |
A4 Hospital and Fertility centre |
| Address |
A4 Hospital and Fertility centre
Room No: 4
87 Arcot road , Virugambakkam
Chennai
Chennai
TAMIL NADU
600092
India |
| Phone |
9750878983 |
| Fax |
|
| Email |
drsreesupriya@a4fertility.com |
|
|
Source of Monetary or Material Support
|
| A4 Hospital and Fertility centre
87 Arcot road Virugambakkam Chennai 600092 |
|
|
Primary Sponsor
|
| Name |
Sree Supriya M |
| Address |
A4 Hospital and Fertility centre
Virugambakkam Chennai |
| 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 |
| DrSree Supriya M |
A4 Hospital and Fertility centre |
A4 Hospital and Fertility centre
Room No: 4
87 Arcot road , Virugambakkam
Chennai
Chennai
TAMIL NADU |
9750878983
drsreesupriya@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 |
| Intervention |
Giving Atosibanto patients undergoing embryo transfer |
Patients undergoing embryo transfer who fulfil our inclusion criteria are divided into two groups, the first group getting Atosiban, Loading dose of 0.9 ml(6.75 mg ) before ET followed by continuous intravenous infusion for 1 hr, 4.1 ml (18 mg ) 20 drops per minute for 1 hour, second group without atosiban. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
23.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Previous atleast one implantation failure
Adenomyosis - by MUSA classification
Grade A and B embryos
|
|
| ExclusionCriteria |
| Details |
Hydrosalpinges on scan and untreated
Moderate or severe endometriosis
Abnormal Chromosome in either or both partners
Fibroids - FIGO 0,1,2
Uncorrected septate uterus
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Biochemical Pregnancy rate |
5 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Implantation Rate |
6 weeks of gestation |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
12/11/2024 |
| 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 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
|
Women undergoing embryo transfer who fulfil the inclusion criteria are selected and divided into two groups - the first group given the full dose - bolus dose followed by continuous intravenous infusion of 18 mg at the rate of 20 drops/min for an hour and 6 drops/min for next 2 hours and the second group proceeded without Atosiban, . Our primary objective is Biochemical pregnancy rate which is determined by a positive urine pregnancy test or serum hCG> 20 mIU/ml measured 2 weeks after embryo transfer. |