| CTRI Number |
CTRI/2021/05/033676 [Registered on: 18/05/2021] Trial Registered Prospectively |
| Last Modified On: |
17/05/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective data analysis |
| Study Design |
Other |
|
Public Title of Study
|
Prediction Of artificial reproductive technology success rate |
|
Scientific Title of Study
|
Cumulative live birth rate per oocyte retrieval in ART cycles – Importance of number of oocytes retrieved |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Devika Gunasheela |
| Designation |
Managing Partner |
| Affiliation |
GUNASHEELA SURGICAL AND MATERNITY HOSPITAL |
| Address |
Department of Reproductive Medicine, No. 1 Dewan N. Madhava Rao Road, Basavanagudi
Bangalore
KARNATAKA
560004
India |
| Phone |
080-46462600 |
| Fax |
|
| Email |
gunasheelaivf@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devika Gunasheela |
| Designation |
Managing Partner |
| Affiliation |
GUNASHEELA SURGICAL AND MATERNITY HOSPITAL |
| Address |
Department of Reproductive Medicine, No. 1 Dewan N. Madhava Rao Road, Basavanagudi
Bangalore
KARNATAKA
560004
India |
| Phone |
080-46462600 |
| Fax |
|
| Email |
gunasheelaivf@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devika Gunasheela |
| Designation |
Managing Partner |
| Affiliation |
GUNASHEELA SURGICAL AND MATERNITY HOSPITAL |
| Address |
Department of Reproductive Medicine, No. 1 Dewan N. Madhava Rao Road, Basavanagudi
Bangalore
KARNATAKA
560004
India |
| Phone |
080-46462600 |
| Fax |
|
| Email |
gunasheelaivf@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gunasheela Surgical and Maternity Hospital, No.1 Dewan N. Madhava Rao Road, Basavanagudi, Bangalore |
|
|
Primary Sponsor
|
| Name |
Gunasheela Surgical and Maternity Hospital |
| Address |
No. 1, Dewan N. Madhava Rao Road, Basavanagudi, Bangalore - 560 004 |
| 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 Devika Gunasheela |
Gunasheela Surgical and Maternity Hospital |
Department of Reproductive Medicine, No. 1 Dewan N. Madhava Rao Road, Basavanagudi
Bangalore
KARNATAKA |
080-46462600
gunasheelaivf@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Gunasheela Surgical and Maternity Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Women who had undergone IVF (In vitro fertilization) /ICSI (Intracytoplasmic sperm injection) |
|
| ExclusionCriteria |
| Details |
1.Donor oocyte cycles
2.Donor embryo cycles
3.IVM (In vitro maturation) cycles
4.Age >40 years
5.PGS/PGD (Preimplantation genetic screening/diagnosis) cycle
6.Embryo pooling cycles
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cumulative live birth rate per oocyte retrieval, stratified according to the number of mature oocytes in younger (less than 35 years) and older women (more than 35 years) |
IVF outcome is measured at 4 weeks after the embryo transfer whether there is a clinical pregnancy or not.
Pregnancy outcome is assessed as, whether they have crossed 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Optimal number of oocytes for a successful live birth in younger (less than 35 years) and older women (more than 35 years |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
17/06/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Will be published in a suitable journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A retrospective observational study to calculate cumulative live birth rates per single oocyte retrieval in IVF / ICSI cycles between January 2015 to December 2019.
The cumulative live birth rate is defined as pregnancy going beyond 24 weeks from oocytes obtained from single egg collection in IVF/ICSI cycles. The embryos formed from the oocytes collected from a single aspiration can be transferred in the fresh cycle or in the subsequent frozen embryo transfer cycle if the fresh cycle fails.
The study included women between the ages of 20 to 40 years and divided into two groups, Group A - included IVF/ICSI cycles in women less than 35 years of age, and Group B - included women more than 35 years of age. Donor oocyte cycles, In vitro maturation cycles, preimplantation genetic screening/diagnosis cycles are excluded from the study.
The cumulative live birth rate is calculated according to the number of mature oocytes retrieved in both Group A and Group B.
Group 1 - Less than 5 oocytes Group 2 - 6 to 10 oocytes Group 3 - 11 to 15 oocytes Group 4 - 16 to 20 oocytes Group 5 - 21 to 24 oocytes Group 6 - more than 25 oocytes
|