| CTRI Number |
CTRI/2023/03/051010 [Registered on: 23/03/2023] Trial Registered Prospectively |
| Last Modified On: |
23/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
study the relationship between an ovarian reserve hormone and the number of eggs retrieved in an IVF cycle |
|
Scientific Title of Study
|
to study the serum AMH correlation with number of oocytes retrieved in controlled ovarian stimulation in Indian women ≤ 35 years: managing patients expectations |
| Trial Acronym |
|
|
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 |
CHAIRPERSON , AKANKSHA IVF |
| Affiliation |
AKANKSHA IVF |
| Address |
AKANKSHA IVF , ROOM NUMBER 628 ,NEW BUILDING , MATA CHANAN DEVI HOSPITAL, BLOCK C1 , JANAKPURI
West
DELHI
110058
India |
| Phone |
45582000 |
| Fax |
|
| Email |
kdnayar@usa.net |
|
Details of Contact Person
Scientific Query
|
| Name |
sakshi nayar |
| Designation |
FELLOWSHIP STUDENT |
| Affiliation |
AKANKSHA IVF |
| Address |
AKANKSHA IVF , ROOM NUMBER 628 , NEW BUILDING , MATA CHANAN DEVI HOSPITAL, BLOCK C1 , JANAKPURI
West
DELHI
110058
India |
| Phone |
9811181718 |
| Fax |
|
| Email |
sakshimiglani11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
sakshi nayar |
| Designation |
FELLOWSHIP STUDENT |
| Affiliation |
AKANKSHA IVF |
| Address |
AKANKSHA IVF , ROOM NUMBER 628 , NEW BUILDING MATA CHANAN DEVI HOSPITAL, BLOCK C1 , JANAKPURI
West
DELHI
110058
India |
| Phone |
9811181718 |
| Fax |
|
| Email |
sakshimiglani11@gmail.com |
|
|
Source of Monetary or Material Support
|
| AKANKSHA IVF CENTRE , ROOM NUMBER 628 , NEW BUILDING , MATA CHANAN DEVI HOSPITAL , C1 BLOCK , JANAKPURI |
|
|
Primary Sponsor
|
| Name |
DR K D NAYAR |
| Address |
AKANKSHA IVF , ROOM NUMBER 628, NEW BUILDING , MATA CHANAN DEVI HOSPITAL , BLOCK C1, JANAKPURI |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| SAKSHI NAYAR |
AKANKSHA IVF CENTER |
ROOM NUMBER 628 , NEW BUILDING, MATA CHANAN DEVI HOSPITAL , BLOCK C1, JANAKPURI
West
DELHI |
9811181718
sakshimiglani11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INDEPENDENT ETHICAL COMMITTEE OF IFS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N971||Female infertility of tubal origin, (2) ICD-10 Condition: N972||Female infertility of uterine origin, (3) ICD-10 Condition: N979||Female infertility, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
23.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
HEALTHY INDIAN FEMALES |
|
| ExclusionCriteria |
| Details |
> 35 YEARS
PREVIOUS IVF CYCLES
PREVIOUS OVARIAN SURGERY / OVARIAN PATHOLOGY
CO-EXISTING MEDICAL CONDITION |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
IN AN CONTROLLED OVARIAN STIMULATION CYCLE IN A PATIENT UNDERGOING IVF , NUMBER OF OOCYTES RETRIEVED IS CORRELATED TO THE SERUM AMH OF THE PATIENT
|
10 TO 15 DAYS OF STIMULATION
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
CO-RELATION OF NUMBER OF OOCYTES WITH SERUM AMH AND CLINICAL PREGNANCY RATE
CUT OFF VALUE OF SERUM AMH TO DETERMINE POOR OVARIAN RESPONDER AND HYPER -RESPONDER |
6 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
27/03/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
SERUM AMH IS ONE OF THE MARKERS TO DETERMINE OVARIAN RESERVE . OTHER PROMINENT MARKERS BEING ANTRAL FOLLICLE COUNT (AFC) AND FSH . IF WE CAN DETERMINE THE COR-RELATON BETWEEN THE VALUE OF SERUM AMH WITH THE NUMBER OF OOCYTES RETRIEVED IN AN INDIAN WOMEN AFTER CONTROLLED OVARIAN STIMULATION , IT WILL HELP IN BETTER COUNSELING AND MANAGING PATIENT’S EXPECTATIONS. SO FAR, TO THE BEST OF MY KNOWLEDGE THERE IS ONLY ONE INDIAN STUDY WHICH HAS LOOKED AT THE SERUM AMH AND THE NUMBER OF OOCYTES RETRIEVED. |