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CTRI Number  CTRI/2025/08/092388 [Registered on: 05/08/2025] Trial Registered Prospectively
Last Modified On: 04/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Hormonal predictors of IVF outcome. 
Scientific Title of Study   Association Of IVF/ICSI Outcome With FSH-AMH And FSH- LH Ratio In Poor Ovarian Reserve 
Trial Acronym  NI 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Divya Pandey 
Designation  Professor 
Affiliation  VMMC and Safdarjung Hospital 
Address  Department of Obstetics and Gyenecology, VMMC and Safdarjung hospital,Delhi
Department of Obstetics and Gyenecology, VMMC and Safdarjung hospital,Delhi
South
DELHI
110029
India 
Phone  8860198440  
Fax    
Email  dr_devya1@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Ritika Kumari 
Designation  PG Student 
Affiliation  VMMC and Safdarjung hospital,Delhi 
Address  Department of Obstetics and Gyenecology, VMMC and Safdarjung hospital,Delhi

South
DELHI
110029
India 
Phone  08860198440  
Fax    
Email  ritikakumari7216@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ritika Kumari 
Designation  PG Student 
Affiliation  VMMC and Safdarjung hospital,Delhi 
Address  Department of Obstetics and Gyenecology, VMMC and Safdarjung hospital,Delhi

South
DELHI
110029
India 
Phone  08860198440  
Fax    
Email  ritikakumari7216@gmail.com  
 
Source of Monetary or Material Support  
VMMC and Safdarjung Hospital,MG Marg,Delhi-110029 
 
Primary Sponsor  
Name  VMMC and Safdarjung hospitalDelhi 
Address  VMMC and Safdarjung Hospital,MG Marg,Delhi-110029 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Divya Pandey  VMMC and Safdarjung Hospital  IVF Centre,Department of Obstetrics and Gyenecology, VMMC and Safdarjung hospital,Delhi
South West
DELHI 		 08860198440

dr_devya1@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N97||Female infertility,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  42.00 Year(s)
Gender  Female 
Details  Women aged 21 to 42 years with infertility undergoing IVF/ICSI with Anti-müllerian hormone
less than 1.2 ng/ml and,or Antral follicle count less than5


 
 
ExclusionCriteria 
Details  1. Donor gamete cycles

2. PCOS

3. Severe male factor infertility

4. Uncontrolled hypothyroidism

5. Uncontrolled hyperprolactinemia
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Number of oocytes retrieved Fertilization rate
Embryo quality
Cycle cancellation rate
 		 BASELINE 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
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   N/A 
Date of First Enrollment (India)   31/08/2025 
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="1"
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  

Background

The management of patients with poor ovarian response (POR) to exogenous gonadotropin stimulation is a challenging problem in in vitro fertilisation (IVF) cycles. The incidence of poor response to ovarian stimulation is estimated to be 9-24%. By identifying reliable, accessible hormonal predictors of IVF success in this subgroup, it is aimed to enhance clinical decision- making and enable more tailored stimulation protocols. This could ultimately improve pregnancy outcomes and provide better prognostic counselling for women with low ovarian reserve.

Based on this evidence collected from the available literature, the current study has been designed with the aim of studying association of IVF/ICSI outcome with FSH-AMH and FSH- LH ratio in poor ovarian reserve. 

AIM-To study association of IVF/ICSI outcome with FSH-AMH and FSH-LH ratio in poor ovarian reserve.

OBJECTIVE: To determine the association of IVF/ICSI outcome with FSH-AMH and FSH- LH ratio in poor ovarian reserve.

Study Design: Prospective Observational Cohort Study

 

Duration: 18 months

 

Setting: IVF centre, Department of Obstetrics and Gynaecology & Department of Pathology, VMMC & Safdarjung Hospital, New Delhi.

Inclusion Criteria

 

Women aged 21–42 years with infertility undergoing IVF/ICSI with Anti-müllerian hormone

< 1.2 ng/ml and or Antral follicle count <5

 

Exclusion Criteria

 

1.      Donor gamete cycles

 

2.      PCOS

 

3.      Severe male factor infertility

 

4.      Uncontrolled hypothyroidism

 

5.      Uncontrolled hyperprolactinemia

 

After screening, enrollment will be done as per the eligibility criteria; informed consent will be taken. ART in this study will include IVF(in vitro fertilisation) and ICSI( intracytoplasmic sperm injection). Workup of the couple will be done as per the institutional protocol. Baseline parameters (FSH,LH, AMH) will be noted on day2/3, antral follicle count(AFC) will be assessd by transvaginal sonography on D2/D3 FSH-AMH and FSH-LH ratio will be calculated. Data will be collected as per the proforma. All women will undergo a standardised ovarian stimulation protocol with tablet letrozole 5mg/day on day 2- 6, along with gonadotropin

(FSH/HMG) 150-225 IU/day from day2/3 onwards. The trigger for ovulation will be given injection hCG when the follicle size is more than or equal to 18mm Oocyte pickup will be done 35-36 hours after the trigger. This will be followed by IVF/ICSI. Subsequently, embryo grading will be done. 

Outcome will be noted in terms of 

number of oocytes retrieved

 Fertilization rate

 embryo quality and cycle cancellation

 rate


 
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